Medical Device Registration Guideline

Transcription

1 Medical Device Registration Guideline Registration and Drug Control Department Ministry of Health - UAE

2 Acknowledgement This guideline was prepared by a technical team under the supervision of: Dr. Fatima Albariki - Director of Registration & Drug Control Department The team members: Dr. Ehab Youssef Abu Eida Ph. Nadia Younis Ph. Mohammed Abdullah References used: A- Global Harmonization Task Force (GHTF) for Medical Device, B- EU Medical Device Directives 93/42/EEC, EU.in Vitro Diagnostic Device Directive (IVDD) 98/79/EC and EU Active Implantable Medical Device Directive (AIMDD) 90/385/EEC. C- US FDA (United State Food & Drug Administration) D- Australia TGA E- Singapore HSA 2

3 Introduction The regulation of medical devices in UAE is aimed to maintain a balance between ensuring product safety, quality and effectiveness and providing the public with timely access to medical devices and preventing the entrance of unsafe or ineffective devices into the UAE market. Accordingly, this guideline is constructed to provide safeguard measures for patients, appliers, users and third parties against possible hazards they may be exposed to as regards their health and safety during the use of such devices and their accessories. The essential requirements in medical devices and their accessories and its implementation were laid down by this guideline to assure that these devices shall meet the internationally established principles and requirements relating to their design, classification, manufacture, placing on the market, putting into service and inspection. In this document we referred to the available guidelines issued by the World Health Organization (WHO), US Food and Drug Administration (FDA), Global Harmonization Task Force (GHTF), Health Canada, Asian Harmonization Working Party (AHWP), European Council Directives 90/385/EEC and 93/42/EEC, Health Science Authority (HAS) of Singapore. Medical Device control and regulation in UAE will be supervised and directed by Drug Control Dept / MOH. Classification, requirements and evaluation of Medical Devices in UAE is supported by the UAE Pharmacy Law No 4 for 1983 and will conform with the global trends, rules and regulations recognized as above. Finally we acknowledge the efforts of the technical team who prepared this guideline and we are looking forward to achieve our goals toward public welfare by their implementation. 3

4 CONTENTS P. No. Definitions 5 Preface 11 Part One General Rules 12 Importation Rules 15 Applicant and Local Representative Rule 16 Recognized Conformity Assessment Body 17 Medical Devices Marketing Approval Flow Chart 18 Classification Of Medical Devices 19 Conformity Assessment 21 Medical Device Manufacturer General Rules 22 The Company Registration Requirements 23 Medical Device Products registration/listing requirements 24 Annex 1 Classification rules 37 Annex 2 Classification Rules for In Vitro Diagnostic 41 Annex 3 45 Annex 4 Application for Medical Device Company 47 Annex 5 54 Annex 6 57 Annex 7 Essential Principles Conformity Checklist 76 Annex

5 DEFINITIONS Accessory Adverse Event AIMD Authorized Representative Body orifice CE Marking on a product: Conformity Assessment An article which, whilst not being itself a medical device or having a specific medical-device-intended purpose, is however intended by its company and its manufacturing site to be used together with a parent medical device to enable that medical device to achieve its intended purpose. A problem that can, or actually resulted in permanent impairment, injury or death to the patient or the user. Active Implantable Medical Device. Any person explicitly designated by a manufacturer, to represent it within a country or jurisdiction where it is not itself established, in respect of matters raised by the relevant Regulatory Authority, with regard to the manufacturer s obligations under the regulations that operate within that country or jurisdiction. Any natural opening on the body including the external surface of the eye socket and any artificially formed permanent opening. indicates to governments that the product can be legally sold within the European Union (EU). ensures the product can move freely throughout the European Single Market, indicates to customers that the product meets designated minimum safety standards and therefore a minimum level of quality, promotes public health and safety, enhances product credibility, leads to improved sales and greater customer satisfaction. Systematic examination to determine the extent to which a medical device fulfils specified requirements. Or/ Any activity relating to the testing and examination and/or certification of the conformity of devices and their accessories to the provisions of this Regulation. Conformity Assessment Body (CAB) Custom-made device Device for performance evaluation EN A body engaged in the performance of procedures for determining whether the relevant requirements in technical regulations or standards are fulfilled. Any device made specifically in accordance with a duly qualified practitioner s written prescription which gives specific design characteristics and is intended for the sole use of a particular patient or client. Any device intended by the company and its manufacturing site to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises. European Norms (Official European Standards) 5

6 Establishment EU FDA GHTF GMP Harm Hazard Implantable device Means a legal person or company and its manufacturing site or importer or distributor or authorized representative (excluding a retailer) responsible for placing a medical device on the market. European Union Food and Drug Administration Global Harmonization Task Force Good Manufacturing Practice physical injury or damage to the health of people, or damage to property or the environment potential source of harm Any device, including those that are partially or wholly to be totally introduced into the human body; or absorbed, which is intended: - to replace an epithelial surface or the surface of the eye, - by surgical intervention which is intended to remain in place after the procedure. Incident Instructions for use Intended use or intended purpose Invasive device IVD Label Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device. An unusual (unexpected) event associated with the use of a medical device. May or may not lead to problems. All incidents should be investigated for potential problems. Information provided by the Company and its manufacturing site to inform the device user of the product s proper use and of any precautions to be taken. Objective intent of the company and its manufacturing site or other legal entity, or person, under whose name the device is placed on the market, in respect of the application and performance of the device, as indicated in the labeling and/or promotional material. A device, which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. Body orifice means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma or permanent tracheotomy. Surgically invasive device means an invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation. Note: Devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices. In-vitro Diagnostic Medical Device Information provided upon the medical device itself. Where physical constraints prevent this happening, this term includes information provided on the packaging of each unit or on the packaging of multiple 6

7 Labeling Manufacturer (Company) and its manufacturing site devices. Affixed to a medical device means written, printed or graphic matter; accompanying a medical device or any of its containers or wrappers, or, device, related to identification, technical description, and use of the medical device, but excluding shipping documents. Of a medical device is the person/organization that place a medical device on the market under his/its own name and, thereby, is responsible for ensuring that the device is suitable for its intended purpose as indicated in the accompanying labeling. The function of the company and its manufacturing site includes one or assignment of the intended design; more of the following activities: sterilization or labeling; assembly; production/fabrication; purpose; modification or re-labeling or refurbishment of packaging; other processing; the medical devices. When any of these responsibilities are subcontracted, the Company and its manufacturing site remains the responsible party. Note 1: Under its own name indicates the needs for the provision of information on the medical device sufficient to allow a beneficiary, user or Regulatory Authority to make contact with the Manufacturer, if such proves necessary. Medical device Note 2: Placing on the market is the initial action of making each finished medical device available on the market, either for payment or free of charge, with a view to its use for the purposes intended by the Company and its manufacturing site as indicated in the labeling. any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: a.) intended by the company and its manufacturing site to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, Indicate the sterilization process completion 7

8 providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and b.) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means. Note 1: The definition of a device for in vitro examination includes, for example, reagents, calibrators, sample collection and storage devices, control materials, and related instruments or apparatus. The information provided by such an in vitro diagnostic device may be for diagnostic, monitoring or compatibility purposes. In some jurisdictions, some in vitro diagnostic devices, including reagents and the like, may be covered by separate regulations. Note 2: Products which may be considered to be medical devices in some jurisdictions but for which there is not yet a harmonized approach, are: aids for disabled/handicapped people, devices for the treatment/diagnosis of diseases and injuries in animals, accessories for medical devices (see Note 3), disinfection substances, devices incorporating animal and human tissues which may meet the requirements of the above definition but are subject to different controls. Note 3: Accessories intended specifically by manufacturers to be used together with a parent medical device to enable that medical device to achieve its intended purpose should be subject to the same procedures as apply to the medical device itself. For example, an accessory will be classified as though it is a medical device in its own right. This may result in the accessory having a different classification than the parent device. Note 4: Components to medical devices are generally controlled through the manufacturer s quality management system and the conformity assessment procedures for the device. In some jurisdictions, components are included in the definition of a medical device. MOH Ministry of Health 8

9 Notified Body 1. A Notified Body is an organization that has been nominated by a member Government and Notified by the European Commission. A Notified Body will be nominated based on designated requirements, such as knowledge, experience, independence and resources to conduct the conformity assessments. PAL Place on the market Putting into service' Regulatory Authority (RA) Risk Risk analysis Risk assessment Risk control Risk evaluation 2. The primary role of a Notified Body is to provide services for conformity assessment on the conditions set out in the New Approach Directives in support of CE Marking. This normally means assessing the manufacturers conformity to the essential requirements listed in each Pharmaceutical Affairs Law of Japan First making available of a medical device with a view to its distribution and/or use, other than where the use is restricted to premarket clinical investigation or performance evaluation of an in vitro diagnostic device Means the stage at which a device is ready for use on the Community market for the first time for its intended purpose. Government agency or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements Combination of the probability of occurrence of harm and the severity of that harm. systematic use of available information to identify hazards and to estimate the risk overall process comprising a risk analysis and a risk evaluation process through which decisions are reached and protective measures are implemented for reducing risks to, or maintaining risks within, specified levels judgment, on the basis of risk analysis, of whether a risk which is acceptable has been achieved in a given context based on the current values of society Risk management systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk Summary Technical Documentation (STED) Summary of technical documentation held or submitted for conformity assessment purposes. Technical File/Technical Documentation Documentation required assessing conformity of the medical device with the regulations. 9

10 Time (Duration) Means the stage at which a device is ready for use on the Community market for the first time for its intended purpose. Transient Normally intended for continuous use for less than 60 minutes Short term Normally intended for continuous use for not more than 30 days Long term Normally intended for continuous use for more than 30 days Concept of continuous use Concepts of duration such as transient short term and long term are defined in terms of continuous use. Continuous must be understood as an uninterrupted actual use for the intended purpose. TGA Validation Vendor Verification WHO Therapeutic Goods Administration, Australia Conformation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled Any person who sells medical devices. This person could be a manufacturer, an importer, a distributor, a wholesaler or a retailer. Conformation, through the provision of objective evidence, that specified requirements have been fulfilled World Health Organization 10

11 PREFACE The application to place a medical device on the UAE market must be made by the device manufacturer or its authorized representative. The manufacturer or its authorized representative is required to maintain objective evidence on the safety and effectiveness of the medical device. The objective evidence is used to assess the quality, safety and effectiveness of the medical device for its intended use, to identify the risks involved when used for the medical condition and to ensure that these risks are acceptable when weighed against its benefits. T he application to place a medical device on the UAE market will result in either Device listing or Device Registration based on approval of the relevant technical committee. 11

12 Part One: General Rules 1 General Rules for Applications: 1.1 Application processing route A. Where a device is intended to administer a medicinal product, that device shall be governed by this guideline, without prejudice to the corresponding regulations for registration of medicinal products for human use set by the Drug Control Dept. If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by corresponding regulations for registration of medicinal products for human use set by the Drug Control Dept. The relevant essential requirements of Annex 7 shall apply as far as safety and performance related device features are concerned. B. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and which is liable to act upon the body with action ancillary to that of the device, the product will be classified considering its main primary mode of action to achieve its intended therapeutic effect. That device must be assessed and authorized in accordance with this guideline. Primary mode of action is defined as the single mode of action of a combination product that provides the most important therapeutic action of the combination product. The most important therapeutic action is defined as the mode of action that is expected to make the greatest contribution to the overall intended therapeutic effects of the combination product. C. All applications shall be made by submitting a dully filled in application form (Annex 4 for Company and Annex 6 for Product) accompanied with prescribed information as detailed in these guidelines and given annexes. Evidence must be submitted to the Drug Control to support the placement of the medical device on the UAE market. D. The company registration file should be submitted at the same time with the registration files of its first product/s. Afterward files for the subsequent products from the same manufacturer could be submitted without the need for the company file. Medical devices for the same company that are under the same category or family (carrying the same trade name) and which share one certification documents could be consolidated within one application and registration file. For 12

13 products which come under listing rule, more than one category can be given at the same time, given that categories are classified within the same line. E. The applications will be processed both for expedite listing and will be issued a listing certificate, or for the review of the Technical Committee which upon approval will be granted a License certificate. F. The registration files should include all required documents and studies for products according to the presentation form and the class of the medical device product. Annex 3 will list the following: Types of medical devices subject for listing Types of medical devices that will be exempted from this guideline and will be regulated at the time of importation. G. Product Registration Dossiers in addition to the non-refundable application fees and the application form, need to include the List of Devices intended to be marketed in UAE in Excel sheet format According to Annex 5 (soft copy and hard copy) with labeling and artwork for each (soft copy). A representative label could be sufficient for those groups of more than 5 versions based on an undertaking letter that the labels will be identical for all those sections which are not related to the differentiating factor (unit size, pack size, software version ), given that, the parts relevant to differentiation should be highlighted. Along with labels a representative sample for each product category, should be provided with the company registration dossier as well as the required certificates for each device. The Dossier for medical devices (whether for listing or registration) will not differ in requirements, as these requirements are based on the product class and labeling and not on the route of registration it will follow. Companies can ask for exemption from sample submission for those devices of big size, or extra expensive. In such a case, the product catalogue and/or sample viewing could be considered by DR&CD. H. Once an application has been accepted the processing of an application will involve evaluation of application, request for additional data/samples and clarification of some issues where applicable. Once a query or a request has been raised, the processing shall halt until after the response to the query has been received. If no response to the query or request is received within six months from the written query notification date, the application could be subject for cancelation or rejection. As part of evaluation of the medical device, a pre-registration GMP inspection or Quality System audit may be conducted to verify compliance. 1.2 All applications and supporting documents shall be made in Arabic or English. 1.3 Declaration by the local authorized representative of the applicant should be 13

14 submitted for all applications to declare that: a. He will insure that all submitted documents are accurate reflection of truth, by ensuring that these were collected and compiled through the right and legal channels, from the concerned responsible parties, that are authenticated by signature and stamping of their source and by all possible means available. b. He will be fully responsible for the product and post market plan submitted for complain handling or recall. c. Will fully comply with the requirements of the Drug control dept after the placing the product in the market. 1.4 Registration/listing Certificate of the device When a device is found to have complied with all the registration requirements, the applicant will be informed to that effect. A certificate of registration or listing shall be issued. The approved artwork and design would be attached with the registration certificates. (if applicable). 1.5 Validity of registration/ Listing: The registration or listing of a medical device shall be valid for five (5) years unless suspended or revoked by Registration and Drug Control Department or terminated by the registrant. The validity of registration shall be subject to:- (a) Submission of biannual post-marketing surveillance reports for those products defined by the DR&CD to be of high risk or require special attention. (b) Submission of adverse effects reports associated with the use of device. (applicable for pharmaceutical products classified as medical devices and class 3 and 4 invasive and implantable medical devices). 1.6 Termination of registration The Registration and Drug Control Department may by giving reasons in writing suspend or revoke the registration of a device, or amend the conditions of its registration. The registrant may by giving 30 days written notice and reasons to the Registration and Drug Control Department terminate the registration of a device. 1.7 Appeals: Any objection to a decision of the Registration and Drug Control Department in relation to any application for registration/listing of a medical device could be submitted in writing to Registration and Drug Control Department. If after consideration of the representations, the department may approve registration/listing of a medical device and if not satisfied it shall reject the application. 1.8 Application for variation of a registered device The Registration and Drug Control Department should be informed on any significant change(s) that could reasonably be expected to affect the safety or effectiveness of a medical device. Significant change(s) may include any (but not limited to) of the following: (a) The manufacturing process, facility or equipment; (b) the manufacturing quality control procedures, including the methods, tests or procedures used to control the quality, purity and sterility of the device or of the materials used in its manufacture; (c) the design of the device, including its performance characteristics, principles of operation and specifications of materials, energy source, software or accessories; and (d) the intended use of the device, including any new or extend use, any addition or 14

15 deletion of a contraindication for the device and any change to the period used to establish its expiry date. The above mentioned major changes will require Registration and Drug Control Department approval before they can be implemented. In case the Manufacturer was not sure of the urgency to report a certain change, the subject of change should be communicated in writing to the DC&RD with a detailed report of expected risk and impact. The Manufacture has to follow the decisions and instruction of DR&CD with regard to the change. Any other minor change(s) should be notified immediately to the Registration and Drug Control Department and may be implemented without prior approval. All applications for variation to a registered/listed device shall be made in writing and shall be accompanied by the variation application fee. 1.9 Applications for renewal of registration Applications for renewal of registration shall be made at least 90 days before the expiry date of registration of the device. The application shall include submission of filled in application form and information pertaining to changes that were made to a registered device. 2 Importation Rules 2.1 All medical devices imports will not be cleared unless a pre-approval for importation of the consignment is issued by Drug Registration and Control Department. This is will be only allowed for importers with MOH medical store license. 2.2 Annex 3 lists all medical devices that are not subject for listing or registration as a condition for pre-import application approval. Documents to be attached to the consignment pre-import approval application form 1-ISO (or appropriate updated quality system in case this ISO standards are subject to change; in case of any change/update the company should ensure that the substituting certificate/document submission is endorsed by DR&CD) issued by recognized conformity assessment Body for the Legal manufacturer and the source (the site where a significant transformation of the medical device is carried out and where the medical device is transformed into its first usable form). 2-Free sale Certificate / documentation or letters of regulatory approval / relevant CE certification/ clearance to manufacture, sell, import and export the medical device from competent authority in export country. 3-Declaration of conformity from legal manufacturer for class 1 devices. 2.3 Used medical devices are not allowed for importation and marketing into UAE. For medical devices need to be exported from and then re-imported into UAE for refurbishment/upgrading/maintenance purposes, the importer should ensure the submission of documents which proofs that the subject medical devices were imported into UAE through legal channels, then exported under approval of the DR&CD. Such consignments will be cleared only upon a pre import permit signed by DR&CD and based 15

16 on proper documentation. 2.4 All devices should carry a clear labeling that includes the name of the company responsible for the placement of the product in UAE market, Manufacturer at Country of Origin, the local distributer address or website that mentions the local distributer name, contact numbers and address. Local Distributors can add stickers on the outer pack of their products in a way that doesn t conceal any basic or essential information. Any Medical Device without distributer contact information will be liable for confiscation. The sticker should be approved by DR&CD. 3 Applicant and Local Representative Rules 3.1 Where a company (Manufacturer) is based outside UAE, they have to appoint local representative to act on behalf of them. A local representative person is the legal entity licensed by ministry of Health, who has received a mandate from the mother company (manufacture at Country of origin / company that owns the rights of the device marketing worldwide) to act on its behalf with regard to matters pertaining to placing the product in UAE Market and all its registration requirements as set by DR&CD. 3.2 The local representative must be appointed in writing, by contract agreement; all duties and responsibilities ought to be clearly defined and assigned. A legalized agreement stating the appointment of the local authorized representative by the company should be submitted. The representative must file an evidence of a legalized Power of Attorney from the company which authorizes him to delegate for his principals. The local Representative may face liability claims resulting either from product malfunction or serious complaint! 3.3 The local representative should be licensed by ministry of health as a medical store or scientific office (in case of scientific office, importation and distribution activities should be performed by an appointed Licensed Medical Store). 3.4 An application for registration of medical device(s) should be made & singed by the Manufacturer in country of origin (MAH in case of pharmaceutical products) jointly with the authorized and qualified local representative. The applicant and its local authorized representative shall be responsible for the product, information supplied in support of the application for registration and any variations thereof. 3.5 The Local Representative Shall: (a) Monitor the device on the market and inform the Authority immediately after the detection of any problem relating to a registered device such as serious manufacturing defects which may endanger public health. (b) Facilitate communication between the applicant and the Authority on matters relating to the product. (c) Handle device recalls. (d) Provide technical support and services to users of registered device(s). 16

17 (e) Required to notify Drug Control Department of any new models of medical devices they market in UAE. (f) Advise accurately on all the Regulatory issues of Labeling, including The Label itself, Product Inserts, Inner and Outer Packaging, Instructions for Use and Advertising etc (g) Can advice on effective implementation of all Regulatory Procedures, including Adverse and Near Incident Reporting, Advisory Notice Issue (including Product Recall), Post Market Feedback, Complaint Handling and Significant Change Notifications. (h) The local representative should appoint a qualified person to act as a local contact person responsible for the product, its registration or listing status updates, can answer queries for all aspects regarding the device, its design and its use and can effectively perform the above duties. The qualifications of this person should be attached within the application along with documented proofs that supports his training by the mother company on the device use and information. 3.6 Change of Local Authorized Representative Principle Companies are free to make any changes desired or necessary for their required Local Representative as far that they are compliant with the relevant UAE laws & regul a t i o n. In such a case the Company is required to report all changes, including the new local representative name, address or phone number, to Drug Control Department within (30) business days supported by a documented clearance issued by relevant authorities responsible for agency and trademarks regulation in UAE. The new rule allows a foreign company s representative to report those kinds of changes directly to Drug Control Department. However, foreign firms are advised to duplicate that reporting effort to ensure compliance. 3.7 The Import of Medical Devices through Distributor that is licensed as a medical store by ministry of health - Drug Registration and Control Department has to comply with a code of practice issued by the Drug Control Department. The main consideration is whether or not an existing distributor of manufacturer s products can act as the authorized representative, in this case distributor has to show evidence of his ability to effectively fulfill the regulatory responsibilities mentioned in above section alongside their marketing activities. 4 Recognized Conformity Assessment Body The Registration and control Department in Ministry of Health may accept third party conformity assessment procedures performed by recognized Conformity Assessment Body, where they are registered and accredited by their respective Competent Authorities having the capability of carrying out assessment of the medical devices. The Conformity Assessment Body shall have technical qualification with the appropriate accreditation or other official authorization and qualified personnel to conduct assessment of medical devices within the scope accredited that shall include scientific technical evaluations of high-risk medical devices and quality system assessments. 4.1 The Conformity Assessment Body shall fulfill the requirements of EN45000 series and ISO/IEC UAE Ministry of Health Drug registration and Control Department shall accept Accreditation of Conformity Assessment Bodies from European Union, Australia, Canada, 17

18 United State, Japan, and Singapore, that are equivalent to Notified Bodies associated with CE marking. 4.3 LIST OF STANDARDS EMPLOYED IN THE ACCREDITATION OF CONFORMITY ASSESSMENT BODIES: 1) TS EN ISO/IEC General Requirements for the Competence of Testing and Calibration Laboratories 2) TS EN General Criteria for Operation of Various Types of Bodies Performing Inspection 3) TS EN General Criteria for Certification Bodies Operating Quality System Certification 4) TS EN General Criteria for Certification Bodies Operating Product Certification 5) TS EN General Criteria for Certification Bodies Operating Personnel Certification 18

19 Medical Devices Marketing Approval flow chart Registration & Drug Control Department Local Authorized representative (Scientific Office) Distributor Medical Store Licensed Registration file for Medical Device Company + registration file of Product(s) (category (line) wise ) Declaration of Conformity of Essential requirements of M.D. Submit Certificate for each device or device category Labeling and artworks Technical Documentation for pharmaceuticals, non listing devices Registration committee (Generally for pharmaceutical dosage form, for products with exaggerated medical claims intended for patients, new technologies, self testing kits) Listing of the Devices (Generally for products used in hospitals under medical professional supervision, classical products with no claims, blood bags, etc, in-vitro diagnostics excluding self testing) Assessment Approval Products exempted from registration or listing Import permit Post market Surveillance Vigilance Reporting 19

20 5 Classification Of Medical Devices 5.1 The control of medical devices will be based on a risk assessment and risk management. The level of regulatory control applied to the medical device is proportional to the degree of perceived risk associated with the device. The requirements of the review process differ for each class, type and technology of medical device. 5.2 Medical devices may be classified into 4 classes: Class l (low risk). II and III (medium risk) or IV (high risk). Refer to annex 1 for classification rules of general medical devices. Class I Devices those needing the lowest level of regulation because of low risk to the patient except sterile products. They are subject to the General Controls requirements. Declaration of conformity is accepted from the legal manufacturer. Class II Devices are of a medium risk. These devices are invasive in their interaction with the human body, but the methods of invasion are limited to natural body orifices. The category may also include therapeutic devices used in diagnosis or in wound management Class III Devices are of a medium risk. They are either partially or totally implantable within the human body, and may modify the biological or chemical composition of body fluids. Class IV devices are of high risk and require design/clinical trial reviews, product certification and an assessed quality system involving clinical trials. These devices affect the functioning of vital organs and/or life-support systems. Devices are usually invasive, life-sustaining, life-supporting, or is used "in preventing impairment of human health or if the device presents a potential unreasonable risk of illness or injury". 5.3 In-Vitro Diagnostic medical devices are based on the potential risk involved in their use and interpretation clinically, refer to Annex 2 for their classification rules. In-Vitro Diagnostic medical devices may be classified into 4 classes: Class A (Low Individual Risk and Low Public Health Risk). Class B (Moderate Individual Risk and/or Low Public Health Risk). Class C (High Individual Risk and/or Moderate Public Health Risk). Class D (High Individual Risk and High Public Health Risk). 5.4 General Consideration in classification In terms of further interpretation of the decision rules, the following should be considered: A. It is the intended and not the accidental use of the device that determines the class of the device. If a medical practitioner uses the device in a manner not intended by the 20

21 company this does not change the class of the device for purpose of conformity assessment. B. It is the intended purpose assigned by the company to the device that determines the class of the device and not the class assigned to other similar products. C. as an alternative to classifying the system as a whole the determination of the class of a particular device may be made with respect to the simplest configuration that can still be considered, in view of its proper functional features, as a device in its own right. A device that is part of a system may be classed as a device in its own right rather than classifying the system as a whole. Similarly combination devices with parts that have different functional purpose may be analyzed separately with respect to each of these parts for instance a drainage device will have an invasive tube and non-invasive collections device. These components may be classified separately. D. Accessories must be classified separated from their parent device. E. If a given device can be classified according to several rules, then the highest possible class applies. F. If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use. Classification of the device will have to be determined on the basis of claims contained in the information provided with the device. The company and its manufacturing site must be sufficiently specific in that regard. If the company and its manufacturing site wants to avoid the particular higher classification, then it must clearly on the labeling the intended purpose in such a way that device falls into the lower class. The company and its manufacturing site must provide as a minimum requirement either appropriate positive or negative indications for use. G. For a device to be "specifically intended" for the purpose referenced in a particular classification rule, the company and its manufacturing site must clearly indicate that the device is intended for such a specific purpose in the information accompanying the device. Otherwise it is deemed to intended to be used principally for the purpose that is accepted in general medical practice. H. Multi-application equipment such as laser printers and identification cameras, which may be used in combination with medical devices, are not medical devices unless their company and its manufacturing site places them on the market with specific intended purpose as medical devices. I. Standalone software, e.g. software which is used for image enhancement is regards as driving or influencing the use of a device and so falls automatically into the same class. Other standalone software, which neither is nor regarded as driving or influencing the use of a device is classified in its own right. 6 Conformity assessment Medical devices company is required to conduct conformity assessment according to the Essential Principles mentioned in this guidance. In certain cases (mostly determined by the risk class of the device), the Technical Documentation may need to be reviewed/ and approval by a Conformity Assessment foreign Notified Body before the applicable device is placed on the UAE market. 21

22 7 Medical Device Manufacturer general rules: In order the company can place a medical device in UAE, should appoint a local authorized representative who is responsible to apply for registration of the company prior or along with its first product registration. For registration of manufacturers of Medical Devices classified as non pharmaceutical dosage form, the file should include the required documents and information relevant to the main manufacturer (final releaser / assembly) to be evaluated according to the set regulation. Declaration from manufacturer should declare the list of their manufacturing site, contract manufacturer, and contract sterilizers, specification developers, re packagers or re labelers, re processors of single-use devices, re-manufacturers, and manufacturers of components or accessories that are sold or leased directly to the end user. The Registration &Drug control Department has the right to ask for certificates for any of the above sites For the registration of manufacturers of Medical devices classified as pharmaceutical dosage form, documentation and information relevant to all sites involved in manufacturing process is required according to set regulation. 7.2 The Manufacturer (could be the product s rights owner, or Marketing Authorization Holder -MAH- in case of pharmaceutical products) at country of origin has to give the technical support to the local authorized representative to submit application, to register the manufacturing facilities where the products are manufactured. If marketing company (product s rights owner) is different than that of the manufacturer an authenticated relationship issued from both parties (jointly or separately) should be submitted. The technical agreements at this level are not needed (see below for product registration). 7.3 A company shall demonstrate compliance with ISO issued by recognized conformity assessment body. The legalized (notarized as true copy if not original then stamped from the UAE Embassy) copies for these accreditations should be attached to the application as direction mentioned in Annex The company shall inform the Registration and Drug Control Department any major changes of his quality management system and change of certification of his quality management system e.g. change of the scope of certification or suspension or withdrawal of certification by the conformity assessment body. 7.5 The Company must prepare provision for audit plan and provide all documents necessary and related to contract manufactures / sterilizers that it employs. 7.6 Contract Sterilizers, Contract Device Manufacturers and Finished Device Manufacturers are considered an extension of the finished device manufacturer's process. The manufacturing site of the finished device is ultimately responsible for assuring that validations, operations, process controls, quality assurance checks, etc. are appropriate, 22

23 adequately documented and correctly performed. Contract sterilizers and contract manufacturers of finished devices are considered manufacturers for the purpose of applying the accreditation. Contract sterilizers and contract manufacturers of finished devices are subject to those parts of the Quality System regulation that apply to the operations that are performed. The finished device manufacturing site bears overall responsibility for the safety and effectiveness of the finished device and must control all contractors. For contract sterilization, the written agreement, between the company and contract sterilizer, required may be referenced to determine how the parties have defined their respective responsibilities. For other contract manufacturers, any written agreements used as part of supplier controls may be referenced to determine how the parties have defined their activities and respective responsibilities. 8 The Company Registration Requirements 8.1 The company applying for registration shall make application in writing by completing an official form Annex 4, which is to be signed by duly authorized representative in the company and by the local authorized representative. 8.2 Company Business License includes their manufacturing site issued by the competent authority in country of origin. 8.3 If the company has multiple manufacturing sites, each manufacturing location should be identified indicating the manufacturing step carried out in as follows(see application for company registration).: A. Design B. Production C. Sterilization (if applicable) D. Packaging E. Labeling F. Final Release. 8.4 Site Master File for each manufacturing site (if applicable- mainly required for pharmaceutical product manufacturers). 8.5 Warehousing & dispatch General Information on Manufacturing Site and quality management system follows. 8.6 Organization of Quality Assurance system (flow chart). 8.7 Notarized copies of certificates pertaining for Quality Accreditations from recognized notified bodies (section above) for each manufacturing facility that involved in the manufacturing of the medical device intended for registration in UAE. 23

24 8.8 For pharmaceutical products / class I (non-sterile) / IVD A manufacturer GMP certificate (or equivalent) and manufacturing License (or equivalent after endorsing that equivalent document by DR&CD) for each of the manufacturing sites is required. 8.9 For classes III & IV / IVD C & D manufacturer: Copies of the Design Examination, Type Examination certificates or equivalent health authority approvals issued for these devices should be provided as a proof of compliance of the company with best practices Report of Recent audit by other auditing organization includes the nonconformities points and evidence of corrective action program and supporting documentation (if applicable) For Sterilization process: full verification that processes are appropriate to produce sterile products should be submitted; including the controlled condition; evidence that process records for each sterilization batch are maintained and traceable to each batch; validation studies including qualification of sterilizer. Proofs that the process is operating within specific limits; if the sterilization process is software controlled, the validation of the software should be submitted; proves and SOPs that shows that the equipment used has been adjusted, calibrated and maintained Post marketing surveillance general plan General profile including the following Information: a) Company name, address, including the corporate structure as well as all company names of the company and its manufacturing site used b) contact name, telephone, fax numbers and addresses c) total number of employees (all shifts) covered by the scope of the audit d) product range and class of medical devices being manufactured (The class of a medical device may differ from one regulatory authority to another) e) types of medical devices sold and/or planned to be sold in the UAE and/or GCC regions for which the regulatory requirements will be assessed, including a complete list of authorizations (e.g., licenses) issued for those medical devices (where applicable) f) Location and function of each site to be included. g) a list of activities performed at each site h) Any special manufacturing processes, e.g., software, sterilization, etc 9 Medical Device Products registration/listing requirements 9.1 Medical devices classified as pharmaceutical product: i.e. has a definite pharmaceutical dosage form, the applicant for these products has to submit the following requirements based on their classification as Sterile or non Sterile: A. Filled application form. 24

25 B. Legalized approval issued by a health authority in Country of origin to market the Product in the relevant country (Certificate of Pharmaceutical Product, or any equivalent ). C. All certificates/documents issued by an assessment bodies as an evidence of regular approval or clearance of the medical device. D. Manufacturing process (Master formula, manufacturing steps, sterilization method used, and manufacturing facilities with steps performed at each). Flowchart for the manufacturing process along with the relevant manufacturing sites should be provided. E. If the manufacturer(s) of any step different than the MAH/ legal manufacturer /authorized representative in Country of origin, authenticated relationship letters from the contract manufacturer along with the technical agreement copy needed. The contract manufacturer should be registered and a separate file should be submitted by the MAH for that purpose, site registration procedures will be followed for each site separately. F. Stability Study with shelf life specifications according to ICH guidelines for zone IV, covering full shelf life, accelerated study for 6 months, in use stability studies (if applicable). G. Lab (QC) Analysis files, after QC file submission, at a later stage the applicant should expect to receive a formal request issued by the Department QC lab section for analysis requirements. These requirements should be submitted as a condition for pricing and/or approval. H. Efficacy & Safety clinical studies (upon request) I. Status of Device Distribution. (see appendix for explanation) J. Arabic- English leaflet and labeling artwork that conforms to COO marketing approval (the Department may ask for some changes, if this is the case the product will not get the marketing approval unless the MAH in UAE submit the new artwork with a sample from the first consignment that conforms to the approved Labeling and packaging artwork. (see labeling requirements in the general guidelines K. For products containing any animal/ human tissues or content, TSE and other requirements may apply, (see appendix for explanation and Guidelines for Biologic and Blood Derivative Products registration and import batch release). L. Price certificate (only required for products subject to pricing, products used for non therapeutic use and aesthetic purpose are exempted from pricing) 9.2 General Medical Devices (MD): Required Technical Documentation The technical requirements to be submitted within the application file are based according to the medical device class, table 2 in Annex 8 show the main classes for General Medical Devices and IN-Vito Diagnostic classes and the required attachment for documents under each type. In addition to the covering letter on the top, the requirements should be 25