TRANSITION PLAN FOR THE IMPLEMENTATION OF MEDICAL DEVICE ACT 2012 (ACT 737)

Transcription

1 TRANSITION PLAN FOR THE IMPLEMENTATION OF MEDICAL DEVICE ACT 2012 (ACT 737) Seminar on MEDICAL DEVICE ACT 2012 (ACT 737) PICC, Putrajaya 28 June 2012 MEDICAL DEVICE CONTROL DIVISION, Ministry of Health Malaysia Level 5, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, Putrajaya Tel: Fax:

2 OVERVIEW OF THE REGULATORY FRAMEWORK PRE-MARKET PLACEMENT ON- MARKET POST-MARKET PRE-MARKET ASSESSMENT Manufacturers of medical devices shall - ensure their products conform to EPSP establish appropriate quality system for manufacturing their products collect evidence of conformity CAB verifies evidence of conformity MEDICAL DEVICE REGISTRATION Manufacturers (or LARs) apply to register medical devices & establishment license ESTABLISHMENT LICENSING Importers/distributors shall - ensure compliance to GDP & advertising requirements apply for establishment license to import/distribute medical devices SURVEILLANCE & VIGILANCE Establishments shall - monitor safety & performance of products carry out post-market obligations, eg complaint handling, FSCA, recall USAGE & MAINTENANCE Users shall use, maintain & dispose off medical devices appropriately Users shall apply for permit to use/operate designated medical devices MDA monitors compliance to requirements & takes appropriate actions in accordance with the provisions of the law

3 Regulatory control RISK-BASED CLASSIFICATION & REGULATORY CONTROL A classification of medical devices based on risk associated with the vulnerability of the human body, the technical design and the manufacture of the medical device It uses a set of classification rules based on: intended use Class Risk Level Device examples duration of use (transient, short-term and long-term) part of human body (non-invasive or invasive with respect to body orifices, surgically invasive interventions, B Lowcentral circulatory system, central Moderate nervous system) A B C D R I S K Device risk/class A Low Simple surgical instruments, tongue depressor, liquid-in-glass thermometer, examination light, simple wound dressing, oxygen mask, stethoscopes, walking aids C High- Moderate Hypodermic needles, suction equipment, anesthetic breathing circuits, aspirator, external bone growth simulators, hearing aids, hydrogel dressings, patient controlled pain relief, phototherapy unit, x-ray films Lung ventilator, orthopedic implants, baby incubator, blood oxygenator, blood bag, contact lens disinfecting/cleaning products, deep wound dressing, defibrillator, radiological therapy equipment, ventilator D High Pacemakers and their leads, implantable defibrillators, implantable infusion pumps, heart valves, inter-uterine contraceptive devices, neurological catheters, vascular prostheses, stents

4 CONFORMITY ASSESSMENT Conformity assessment (CA): Systematic examination of evidence generated and procedures undertaken by the manufacturer under the requirements established by the Regulatory Authority to determine that a medical device is safe and performs as intended by the manufacturer and, therefore, conforms to the Essential Principles of Safety and Performance for Medical Devices What To Look For In CA? Objective evidence for conformance to Essential Principles of Safety & Performance of Medical Device 6 general principles 11 design and manufacturing principles

5 CONFORMITY ASSESSMENT Essential Principles of Safety & Performance of Medical Device General Principles Medical device should be designed & manufactured in such a way that: no compromise to clinical condition or safety of patients, or safety and health of users or other persons control the risk so that residual risk is brought down to an acceptable level suitable for one or more of the functions within the scope of the definition of a medical device characteristics and performances should not be adversely affected to such a degree that they compromise the health or safety of patient or user and other persons during the lifetime of the device characteristics and performances during their intended use will not be adversely affected under transport and storage conditions benefits must be determined to outweigh any undesirable side effects Design and Manufacturing Principles Chemical, physical and biological properties Infection and microbial contamination Manufacturing and environmental properties Devices with a diagnostic or measuring function Protection against radiation Requirements for medical devices connected to or equipped with an energy source Protection against mechanical risks Protection against the risks posed to the patient by supplied energy or substances Protection against the risks posed to the patient for devices for self-testing or self- administration Information supplied by manufacturer Performance evaluation including where appropriate, clinical evaluation

6 CONFORMITY ASSESSMENT Elements of CA QMS (ISO or equivalent, GDPMD) Post-market surveillance system (GHTF recommendations) Summary technical documentation (ASEAN CSDT) Declaration of conformity (DoC) (GHTF recommendations) Registration of medical device & licensing of establishment Declaration of Conformity (DoC) A DoC is a declaration made by the manufacturer of a device that the device is in conformity with the regulatory requirements DoC declares that the manufacturer guarantees that each piece of the device sold is in conformity with the regulatory requirements Summary Technical Documentation Format ASEAN CSDT Compliance to EPSP (GHTF recommendations - Essential Principles of Safety & Performance of Medical Devices) Acceptable standards or equivalence will be widely used (GHTF recommendations - Role of Standards in the Assessment of Medical Devices) CAB determines the adequacy of the documented evidence to support attestation of conformity Quality Mgmt System (QMS) For manufacturer, ISO or equivalent Class A & B products, can exclude design control, process control, inspection & testing For Class C, full QMS For Class D, full QMS PMS system Technical evaluation of sterilization process (if any) For LAR, importer, distributor: GDPMD Post-Market Surveillance System (PMS) Distribution records Complaint records Adverse incident reporting (GHTF recommendations - Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices) FSCA reporting (GHTF recommendations - Medical Devices Post Market Surveillance: Content of Field Safety Notices)

7 CONFORMITY ASSESSMENT CA PROCESS & PARTIES INVOLVED Conformity assessment is primarily the responsibility of the medical device manufacturer. However, it is done in the context of the established regulatory requirements and both the process and conclusions are subject to further review by the Regulatory Authority Manufacturer conducts CA on; (i) QMS & PMS (ii) Product safety & performance (summary tech doc & DoC CAB reviews evidence of conformity Authority reviews & registers product & licenses establishment What is a CAB? A body authorized by the Authority to perform specified CA activities to determine whether the relevant requirements in technical regulations or standards are fulfilled CAB is independent of the organization that provides the product and is not a user of the product (3 rd party) Authority will monitor the performance of the CAB and, if necessary, withdraw authorization

8 CONFORMITY ASSESSMENT Class QMS PMS system Class A, Class A(S) Class A(M) Class B Class C Class D Level of CA The level of CA is proportional to the risk associated with the device Est & maintain can excl design & dev control. Class A may be audited for special cases. For Class B, make available for audit Establish, maintain full QMS make available for audit Establish & maintain adverse event reporting procedure for audit. For Class A, audit may be required to investigate specific safety or regulatory concerns A Self declare B Tech doc CSDT Prepare, make available upon request. For Class B may be reviewed for conformity to EPSP Prepare & submit for review C DoC D Product design & manufacturing control R I S K Prepare, sign & submit for review Registration & licensing Perform according to requirements

9 WHAT DO WE NEED TO IMPLEMENT THE REGULATORY SYSTEM? Legal support, ie the Acts Subsidiary legislations & guidance documents Medical Device Authority & organization Registration & licensing system Internal processes & procedures Register, database & resource center Forms Criteria Procedures

10 MEDICAL DEVICE REGISTRATION ROUTES Stop B, C, D Conformity Assessment By CAB or MDA No 1. Technical File 2. ISO QMS Stop Yes Medical device? Grouping: Single System Kits Group Yes No Qualified for abridged? r OK? Yes 1.Application Form 2. DC from Product Owner/Manufacturer 3.CSDT 4. Class B, C if Required- Clinical evidence Class C&D Clinical Evaluation Evaluation No Decision Yes Pay fee B, C, D Class? Class A Sterile MD -ISO (In-House) -ISO (Sterile Services) -Process Validation (Report) Class A Measuring Function MD -Process Validation (Report) MEDICAL DEVICE REGISTER A Class A 1.Application Form 2. Declaration of conformity 3. Certified QMS. If no, attestation by manufacturer 4. Simplified CSDT

11 LICENSING OF ESTABLISHMENTS Establishment means a person/organization who is either a manufacturer, authorized representative (for foreign manufacturer), importer or distributor of medical devices, but does not include a retailer Different type of establishment has different roles & responsibilities different set of control Establishment must possess valid license to carry out activities related to medical devices in Malaysia Importer Foreign manufacturer Authorized representative Distributor Imported device Local manufacturer Distributor Locally-made device Relationship between different establishments

12 LICENSING OF ESTABLISHMENTS Authorization: Appropriate authorization from the respective establishment is required as a pre-requisite for the issuance of license Authorized rep must be authorized by foreign manufacturer Importer must be authorized by authorized rep to import devices on its behalf Distributor must be authorized by manufacturer/ authorized rep to distribute devices on its behalf An entity may apply for license for different types of establishment Manufacturer as defined in Section 2 of MD Bill 2011: definition of manufacturer Authorized representative as defined in Section 2 of MD Bill 2011: definition of manufacturer Authorized representative must be natural or legal person with business registration in Malaysia. It must maintain linkage with its foreign manufacturer and should be able to obtain the support of its foreign manufacturer whenever required. Distributor: Any natural or legal person in the supply chain authorized by the manufacturer/authorized representative to further the availability of medical devices to the end-user. In some circumstances, more than one distributor may be involved in this process Importer: Any natural or legal person authorized by authorized representative, who first makes a medical device manufactured in other countries, available in the Malaysian market

13 LICENSING OF ESTABLISHMENTS Requirements Local manufacturer Authorized rep Importer Distributor Establishment details Appropriate authorization Procedures for; Distribution records Complaint handling Adverse incident reporting Field safety corrective action List of medical devices ISO or equivalent Good Distribution Practice for Medical Devices (GDPMD)

14 GDPMD FOR AUTHORIZED REP, IMPORTER & DISTRIBUTOR Foreign manufacturer Local manufacturer Importer Local authorized representative Distributor Distributor Imported medical devices Importer Locally-made medical Distributor devices

15 SAVINGS & TRANSITIONAL Section 80 of MD Act 2012 (Act 737): Savings and transition All medical devices shall be registered within 24 months from the appointed date All establishments shall be licensed within 12 months from the appointed date

16 CURRENT STATUS: THE ACT MD Act 2012 (Act 737) & MD Authority 2012 (Act 738) 3 Oct 2011: Passed by Lower House of Parliament 7 Dec 2011: Passed by Upper House of Parliament Already gazetted

17 CURRENT STATUS: ORGANIZATION New statutory body setup: Medical Device Authority early Q Human resource already approved PSD MEDICAL DEVICE AUTHORITY (MDA) A body corporate with the following members - DG of Health as the Chairman - Chief Executive of the MDA - a representative of Min of Finance - a representative of Min of Health - not more than five persons appointed by the Minister, who have expertise and experience in medical device matters Committees appointed by MDA - to assist in the performance of the functions of the Authority Functions of MDA To implement, enforce, consider and recommend reform to the medical device laws To perform the following - to regulate all matters - to provide consultancy & advisory service and any other services in relation to medical device, its industries and activities To utilize property of the Authority in such manner as the Authority may think expedient To impose fees or charges for services rendered

18 CURRENT STATUS: SUBSIDIARY LEGISLATIONS MD (Pre-Market) Regulations 1 st phase: draft pre-market regulations is ready Registration of MD Classification Grouping Conformity assessment procedure Application procedure for registration Renewal of registration Changes concerning registered MD Exemption Cancellation of registration Registration CAB Establishment license Etc.. To be submitted to AG s Chamber: August 2012 Forms Fee structure Criteria Conditions Procedures Other details

19 CURRENT STATUS: GUIDANCE DOCUMENTS Guidance Documents Awaiting publication (i) Definition of Medical Device (ii) Risk Based Classification (iii) Essential Principles of Safety & Performance of Medical Device (iv)common Submission Dossier Template (v) Good Distribution Practice for Medical Devices (vi) IVD Medical Device Classification System (vii) Essential Principles of Safety and Performance for IVD Medical Devices (viii) Conformity Assessment for IVD Medical Devices (ix) Common Submission Dossier Template for IVD Medical Device Under development (i) Conformity assessment body (ii) Declaration of Conformity (iii) Guidelines for product registration (iv)grouping of medical devices

20 REGISTRATION OF MEDICAL DEVICES Medical device regulatory system is based on safety & performance of medical devices throughout their life cycle Prior to registration of a medical device, CA is conducted to provide objective evidence of safety & performance a medical device Only registered medical devices can be placed into the market Establishments dealing with medical devices must comply with conditions and carry out their obligations Who shall be responsible? Licensed local manufacturers or authorized rep What would be required? Submission of CSDT Submission of DoC Establishment, maintenance and making available of QMS & PMS documents for audit Upon approval, the medical device will be put in the Medical Device Register Abridged Assessment Applicable for medical devices which have already approved by the relevant authority to be marketed in US, EU, Canada, Australia, Japan. Otherwise, full assessment shall be done

21 CURRENT STATUS: New registration & licensing system ESTABLISHMENT LICENSING MEDICAL DEVICE REGISTRATION CAB REGISTRATION COMPETENCY REGISTRATION SERVICE PROVIDER REGISTRATION

22 ESTABLISHMENT LICENSING Authorized representative

23 MEDICAL DEVICE REGISTRATION

24 MEDICAL DEVICE REGISTRATION

25 NOW TO MANDATORY PHASE Passing of MD & MD Authority Bills Gazettement of MD & MD Authority Bills Announcement of appointed dates of implementation MD & MD Authority Acts Establishment of MD Authority Appointed date of implementation of MD Act Mandatory implementation MD Act 3-Oct Dec-2011 End Feb July Oct Oct-2014 Preparation & development of MD Act Preparation & development of computerized system Preparation & development of subsidiary legislations Appointment of members of MD Authority Appointment of Chief Executive of MD Authority Transition of MD Control Div to assist in the establishment of MD Authority Preparation & development of regulations, guidance documents & standards for the implementation of MD Act

26 Registration of Products and CABs Licensing of Establishments NOW TO MANDATORY PHASE Mandatory implementation of MD Act Appointed dates of implementation MD Act Establishment of MD Authority Gazettement of Bills Passing of Bills Phase 3: Imposition of other obligations Phase 2: Imposition of GDP for other establishments Phase 1: Imposition of ISO13485 for manufacturers Phase 5: Registration of IVD Phase 4: Registration of Class B &C Phase 3: Registration of Class D Phase 2: Registration of CAB Phase 1: Registration of Class A Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Voluntary Transition Mandatory

27 CAB guidance document (GD) CAB registration system NOW TO MANDATORY PHASE CAB Registration System Implementation of CAB registration Development of CAB registration system Finalization of GD Comments of GD from interested parties Development of GD June July August September October

28 SUMMARY Regulatory framework & legal support are in place Current status: Work is progressing putting the detailed pieces together Moving forward regulatory activities will be introduced in phases, timeline Awareness & consultations

29 .Thank you for your attention