5. Further applicable documents

Transcription

1 Supplement-Checklist for the assessment in accordance with under CMDCAS 1. Purpose This checklist is a supplement to Supplement Assessor Guideline MDD and CMDCAS 780E1, and the Checklist for the Assessment in Accordance with the Standards etc. 780E1_E. It describes the auditing procedure for quality management systems according to under the Canadian Medical Devices Conformity Assessment System (CMDCAS) based on the Health Canada guidance documents GD 207 (November 2007) and GD 210 (January 2007). This document replaces the previous version based on the previous versions of Health Canada guidance documents. 2. Scope This checklist is applicable for the certification and oversight of the quality systems of the manufacturers of class II, III and/or IV medical device(s) according to the Canadian Medical Devices Regulations, who have submitted or are intending to submit an application for Medical Device Licence(s) to Health Canada. 3. Responsibilities and authority Lead auditor The lead auditor is responsible for the examination and evaluation of the QM system in respect of the customer s system documentation, the related standards and the ruling according to and the additional requirements under the CMDCAS program. He is responsible for the work of the audit team and for the observance of the DQS processes. In case where the lead auditor is not an expert himself, he should accept the evaluation of the conformity under CMDCAS by the expert without any protest. Expert The expert is responsible for the competent evaluation of the aspects of the QM system that are specific under the CMDCAS program. The assessment of the quality system s effectiveness in terms of ensuring observance of the Canadian Medical Devices Regulations, especially those parts applicable to class II, III and/or IV medical devices, is his essential task. 4. Approach to the evaluation This checklist can be applied only in combination with the checklist 780E1_E. The requirements included in this checklist should be audited along with the corresponding parts of the general requirements using the process approach, as outlined in the checklist 780E1_E, and not as a separate part of the audit schedule. All nonconformities shall be reported directly against a requirements of and never directly against a section of the MDR. If the manufacturer has not adequately addressed one or more applicable requirements of the MDR, the nonconformity shall be cited against the corresponding requirement, with reference to the missing section of MDR as objective evidence to support the nonconformity. If the suitable requirement cannot be found, the nonconformity can be reported against the The present checklist must be used as instrument to perform the assessment. The assessment results must be formulated in the audit report, where a reference to this checklist can be made. 5. Further applicable documents 780E1 Assessors Guideline Supplement 780E1_E-Checkliste EWG-9001 Canadian Medical Devices Regulations (MDR) (latest version available from Justice Canada at Health Canada guidance documents, especially GD 207 and GD 210 (available from Health Canada homepage at Version: / 13

2 Health Canada Medical Devices Active Licence Listing at (MDALL), and Medical Devices Establishment Licence (MDEL) Listing at and other further applicable documents and standards referenced. The original text of MDR, GD210, GD207, and the current manufacturer s licence listings (MDALL, MDEL) must be available to the audit team during the audit. 6. Application of the assessment checklist The checklist serves for the evaluation of audit results. Each audit requirement should be evaluated separately. The evaluation of the documentation and implementation of a standard s requirement should be documented in the column in the following way: 1 = fulfilled 2 = partially fulfilled, still acceptable 3 = partially fulfilled, not acceptable 4 = not fulfilled na = not applicable The numbering of the questions corresponds to the numbers of the requirements as printed in and GD 210 (in the italic font). 7. Audit protocol Please use the DQS form Findings ( Feststellungen ). The findings must contain a reference to the standard s requirements. These can be entered in the column Reference ( Referenz ). Please use the numbering system of the standard using at least two digits of the requirement s number (e.g. 4.2 for Documentation Requirements ). Additional evidence, such as copies of manufacturer s documentation, should be identified clearly (e.g. using the numbers). 8. Abbreviations CMDCAS Canadian Medical Devices Conformity Assessment System MDR Canadian Medical Devices Regulations HC Health Canada SCC Standards Council of Canada QMS quality management system Ref. No.: Company: Date(s) of Audit Auditor s Name Auditor s Signature Initial / Re-Certification Advancement Advancement Version: / 13

3 1 Scope 1.1 General This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. 1.2 Application If regulatory requirements permit exclusions of design and development controls (see 7.3), this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with this International Standard reflect exclusion of design and development controls [see a) and 7.3]. Most recent consolidated version of Part 1, Medical Devices Regulations (MDR) 32(2)(f) permits exclusion of Design and development controls (element 7.3) from the QMS for Class II medical devices. It says that :2003 shall be used by a Manufacturer to demonstrate that it can provide medical devices that meet customer as well as regulatory requirements. Are any exclusions (e.g. 7.3) and non-applicabilities (e.g. s and ) of s from supported with details of the justification in the quality manual? The manufacturer cannot exclude Design and development controls if their intention is to obtain a class III or IV device licence. Does the audit scope include, for Class II devices, manufacture [production], for Class III or IV devices, design and manufacture, for all medical devices for which the Medical Device Licences exist or an application is planned? Review with the MDALL database: manufacturer on the Licence = manufacturer on the CMDCAS certificate licenced medical device s type and class correspond to the medical device s generic definition of the certificate 3 Terms and definitions Existing 9000:2005 and :2003 definitions. This is not a requirement of :2003 but is meant to inform the reader. Where this a conflict of definitions, the MDR definitions take precedence....definitions should be regarded as generic, as definitions provided in national regulations can differ slightly and take precedence. Part 1, Section 1 Interpretations In the MDR "Manufacturer" means a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. The MDR holds the "Manufacturer" responsible for the safety and effectiveness of the medical device. The Manufacturer shall be certified to :2003 by a Health Canada Recognized Registrar. QMS certificates must be issued to the organization that meets the MDR definition of the Manufacturer. Does the manufacturer meet his regulatory definition? Revision: 0a / / 134

4 3.3 Advisory notice notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information and/or to advise what action should be taken in the use of a medical device, the modification of a medical device, the return of the medical device to the organization that supplied it, or the destruction of a medical device NOTE Issue of an advisory notice might be required to comply with national or regional regulations. 4 Quality management system Part 1, Section 1 Interpretations "recall", in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device a. may be hazardous to health; b. may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or c. may not meet the requirements of the Act or these Regulations. The intent of a regulatory "recall" is consistent with the "advisory notice". 4.1 General requirements The organization shall...identify the processes needed for the quality management system and their application throughout the organization (see 1.2)... 2, 3, 5 Application 6, 7 (including Schedule 1) Classification 26 Prohibition 28 to 31 Devices deemed licensed 32, 33 Application for a device licence 34 Amendment to a device licence 43 Obligation to inform 43.1 Obligation to submit certificate If some of the MDR requirements have been delegated by the legal Manufacturer to another area of the organization, has the delegation of responsibility been clearly defined and documented? Is there more than one geographic location which is used in the design and manufacturing process? Is there a designated regulatory correspondent? If YES the regularory correspondent is to be involved in the audit! Offsite auditing using the document review and/or distant communication is possible. REGULATORY CORRESPONDENT is a person that is officially authorized by the manufacturer to be its contact with HC with respect to its licenced devices. Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system (see 8.5.1). Does the Manufacturer have control over all outsourced processes and are these control mechanisms identified within the QMS? The MDR hold the "Manufacturer" responsible for the safety and effectiveness of the medical device including the design, fabrication, assembly, sterilization, shipping etc. The Manufacturer must demonstrate control over these processes. (A) Is the manufacturer responsible for its finished medical devices meeting regulatory safety, effectiveness and QMS requirements regardless of whether the manufacturer has outsourced the supply of parts, material, services or Revision: 0a / / 134

5 4.2 Documentation requirements General The quality management system documentation shall include...f) any other documentation specified by national or regional regulations. Where this International Standard specifies that a requirement, procedure, activity or special arrangement be "documented", it 9(2) A manufacturer shall keep objective evidence to establish that the medical device meets those requirements. [safety and effectiveness] 10 to 20 Safety and Effectiveness Requirements 32 Application for a Medical device finished medical devices? (B) Does the supplier have a substantial involvement with the manufacture or design of the medical device? Is the supplier undertaking the supply of a part, material or service, which may affect the conformity of the medical device with the Safety and Effectiveness requirements of MDR? If the answer is YES to (A) or (B) Is there enough objective evidence at the legal manufacturer s location that shows the competence of the supplier (subcontractor) to undertake supply of the part, material or service in relation to the medical devices that are manufactured or designed under the scope of the registered QMS? Such evidence is to be especially evaluated in terms of the control and risk mitigation by the manufacturer over the supplier and their products/services, e.g.: design and product requirements personnel qualifications verification that subcontracted products meet specified requirements specifying a QMS under which the subcontracted products are designed and manufactured performing the on-site inspections validating processes a QMS certificate with which DQS has confidence o issued by a HC recognized registrar (look up in the listing at the HC homepage) o accredited (by SCC) and not expired o covering the parts, material, service or finished medical devices used by manufacturer or a demonstration of manufacturer s adequate controls / risk management of the outsourced product / process. Does the Manufacturer have files (often called the Technical File or Device Master File) that contain, or refers to the location of the evidence of safety and effectiveness required in Sections 10 to 20? These files, or parts of them, can be used to satisfy the : Class II licence application requirements of Sections 32(1) and (2); Class III licence application requirements of Sections 32(1) and (3); or Revision: 0a / / 134

6 shall, in addition, be implemented and maintained. For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements (see 4.2.3). These documents shall define the complete manufacturing process and, if applicable, installation and servicing. Licence For Class II devices refer to 32(1) and (2) for minimum requirements. For Class III devices refer to 32(1) and (3) for minimum requirements. For Class IV devices refer to 32(1) and (4) for minimum requirements. Class IV licence application requirements of Sections 32(1) and (4). Have these regulatory requirements been documented in the Quality Manual? Refer to the original wording of MDR sec. 31(1) 31(4) for the minimum requirements Quality manual and maintain a quality manual that includes...a) the scope of the quality management system, including details of and justification for any exclusion and/or non-application (see 1.2) Control of documents Existing :2003 QMS requirements Control of records The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by the relevant regulatory requirement. 5 Management responsibility 5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining its effectiveness by...communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements... 32(2) f) Application for a Class II device licence - QMS requirement No specific requirement in MDR. 55, 56 Distribution records 66 to 68 Implant registration No specific requirement in MDR. Applicable only to Class II medical device Manufacturers If the Manufacturer excludes element 7.3 Design and development from the scope of the QMS, does the quality manual contain a detailed justification of its exclusion? Is the justification based on the Section 32(2)(f)? Does the Manufacturer have the most recent consolidated version of the MDR including any amendments published in Canada Gazette Part II? Has the Manufacturer identified the lifetime of the medical devices? Has the Manufacturer defined the record retention period for distribution records in respect of a medical device for the longer of (a) the projected useful life of the device, or (b) two years after the date the device is shipped? Does objective evidence exist of top management's commitment to meeting the requirements of the Canadian MDR? ( e.g. Device Licensing, Mandatory Problem Reports, Recalls etc.) Revision: 0a / / 134

7 No specific requirement in MDR. 5.6 Management review Review input No specific requirement in MDR. Is a review of new or revised MDR part of the input to management review? 6 Resource management Competence, awareness and training No specific requirement in MDR. Have the people who perform regulatory activities been trained in the understanding of the MDR? 6.3 Infrastructure The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a. buildings, workspace and associated utilities, b. process equipment (both hardware and software), and c. supporting services (such as transport or communication). 14 Transport and storage Does the Manufacturer have and maintain the necessary infrastructure to ensure that the characteristics and performance of their medical device(s) is(are) not adversely affected by transport or conditions of storage? 7 Product realization 7.1 Planning of product realization The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1). documented requirements for risk management throughout product realization. Records arising from risk management shall be maintained (see 4.2.4). 7.2 Customer-related processes 32(4)(e) submit a quality plan with a Class IV device application 9 Manufacturer's Obligations 32(4)(d) submit risk assessment with Class IV device application 10 Manufacturer to perform risk analysis Does the Manufacturer have a quality plan (which is also submitted to Health Canada with Class IV medical device applications) that specifies the processes and resources for specific medical devices? Have risk assessment and control measures been performed throughout the product realization process for all classes of medical devices? Note 1: See 14971:2000 for guidance related to risk management. Note 2: See GHTF SG3 guidance document "Risk Management as an Integral Part of the Quality Management System" for additional guidance Determination of requirements related to the product Revision: 0a / / 134

8 The organization shall determine...c) statutory and regulated requirements related to the product 7.3 Design and development Design and development inputs Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include a) functional, performance and safety requirements, according to the intended use, b) applicable statutory and regulatory requirements... e) output(s) of risk management (see 7.1). 2 to 5 Application 6 to 7 Classification 8 to 9 Application & Manufacturer's Obligations 10 to 20 Safety and Effectiveness 21 to 23 Labelling 24 Contraceptive Devices Advertising 26 to 27 Prohibition 28 to 31 Medical Devices Deemed Licensed 32 Application for a Medical device Licence 34 Application for licence amendment 43 Obligation to inform 52 to 56 Distribution records 57, 58 Complaint handling 59 to 62 Mandatory problem reporting 63, 64 Recall 66 to 68 Implant registration Schedule 1 Classification rules for medical devices Schedule 2 list of Implants that must comply with the implant registration requirements of section Manufacturer to perform risk analysis 11 Device must not adversely affect the health or safety of a patient 13 Characteristics and performance of device must not deteriorate under normal use 14 The characteristics and performance of a medical device shall not be adversely affected by transport or conditions of storage 15 Compatibility - Materials used the manufacture of the device 16 Minimum risks to a patient and other person from foreseeable hazards 18 Compatibility between parts and components 19 Measuring function to perform within tolerance limits Has the Manufacturer determined the applicable statutory and regulatory requirements that apply to the medical device? Did the Manufacturer use the Classification rules in Schedule 1 to classify any new medical devices? Does the Manufacturer track changes to the information and documents that had been supplied earlier to Health Canada but did not lead to a licence amendment? Are these changes reported during the annual licence renewal process required in section 43(1) (b)? Is the Manufacturer only selling licensed medical devices in Canada (see Refer to manufacturer s MDALL listing to check the classification and compare manufacturer s identification in the licence and in the (draft) certificate. (Note: Objective evidence to satisfy this requirement will be found either at the legal Manufacturers location or at another location that is part of the Manufacturer's organization like a Canadian subsidiary that is controlled through the organization's QMS. See [GD210] Annex C for auditing simple and complex multi-site organizations) Has the Manufacturer determined the design and development inputs related to the regulatory safety and effectiveness requirements? Has the Manufacturer determined the medical device licensing requirements for Class II, III or IV medical devices? Revision: 0a / / 134

9 32 Application for a medical device licence requirements Design and development validation As part of design and development validation, the organization shall perform clinical evaluations and/or evaluation of performance of the medical device, as required by national or regional regulations Control of design and development changes 7.4 Purchasing Purchasing process documented procedures to ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product 12 device shall perform as intended 32(3)(f) and 32 (4)(i) : studies on Class III and IV devices to ensure safety and effectiveness 20 validation of software used in a device 1 MDR definition of a "significant change" Significant change means a change that could reasonably be expected to affect the safety or effectiveness of a medical device (a) the manufacturing process, facility or equipment; (b) the manufacturing quality control procedures, including the methods to control the quality, purity and sterility ; (c) the design of the device ; and (d) the intended use of the device, including any change to the period used to establish the expiry date. 34 Application for a medical device licence amendment for Class III or IV device in the event of a "significant change" 43(1)(b) Obligation to inform minister at time of annual licence renewal of any change to information or documents that do not meet Section 34 requirements. No specific requirement in MDR. Has design and development validation been carried out and does the medical device perform as intended? Has design and development validation been performed on initial production medical devices or their equivalents? Has the performance of any software used in the medical device been validated? Does the Manufacturer have a process or procedure for identifying a "significant change" to a Class III or IV medical device? Does the Manufacturer have a procedure for amending a Class III or IV medical device licence in the event of a significant change to a medical device? Does the Manufacturer track changes to the information and documents that had been supplied earlier to Health Canada but did not lead to a licence amendment? Are these changes reported during the annual licence renewal process required in section 43(1)(b)? Following any design and development changes, is the device master file (technical file) updated? Review the corresponding procedures and their application. Do Manufacturers who use suppliers to provide finished medical devices have documented procedures in place to ensure that the finished medical device is safe and effective? Do Manufacturers who use suppliers to provide parts, components or services that could affect the safety and effectiveness of the finished medical device have documented procedures in place to ensure that the finished medical device is safe and effective? Revision: 0a / / 134

10 on subsequent product realization or the final product. Also refer to 4.1 in this checklist! Purchasing information Purchasing information shall describe the product to be purchased, including where appropriate... quality management system requirements. No specific requirement in MDR. 7.5 Production and service provision Control of production and service provision General requirements The organization shall plan and carry out production and service provision under controlled conditions. 17 Validation and control of sterilization process If the medical device is to be sold in a sterile condition, is it manufactured and sterilized under appropriately controlled conditions, and is the sterilization method used validated? Control of production and service provision - Specific requirements Particular requirements for sterile medical devices 17 Validation and control of sterilization process Validation of processes for production and service provision Particular requirements for sterile medical devices documented procedures for the validation of sterilization processes. Sterilization processes shall be validated prior to initial use. Records of validation of each sterilization process shall be maintained (see 4.2.4) Identification and traceability Traceability 17 Validation and control of sterilization process Does the Manufacturer have documented procedures for the validation of sterilizations processes? Was the sterilization process validated prior to initial use? Does the Manufacturer have and maintain records of validation of each sterilization process? Review the objective evidence of appropriate manufacturer s control and validation of sterilization General documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required (see 4.2.4, 8.3 and 8.5). Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 21 c) & d) Labelling 52 & 54 Distribution records Do medical devices labels contain: a) the name of the medical device; b) the name and address of the Manufacturer; c) the identifier of the medical device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family; d) in the case of a Class III or IV medical device, the control number? Refer to the original wording of MDR sec. 21(1) to review the labelling! Revision: 0a / / 134

11 4.2.4) documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required (see 4.2.4, 8.3 and 8.5). Where traceability is a requirement, the organization shall control and record the unique identification of the product Particular requirements for active implantable medical devices and implantable medical devices The organization shall require that its agents or distributors maintain records of the distribution of medical devices to allow traceability and that such records are available for inspection... Records of the name and address of the shipping package consignee shall be maintained (see 4.2.4). 52 to 56 Distribution Records Do the Manufacturer's distributors have records of distribution of medical devices and are these records kept for the longer of, the projected useful life of the medical device as defined by the Manufacturer, or two years after the medical device was shipped? Do distribution records contain sufficient information to permit a complete and rapid withdrawal of a Class II, III or IV medical device from the market? Is the projected useful life of the medical device defined? 66 Implant registration (Applicable to devices listed in Schedule 2 of the MDR that are : 1. Heart valves 2. Annuloplasty rings 3. Active implantable device systems a. all models of implantable pacemakers and leads; b. all models of implantable defibrillators and leads; c. artificial heart; d. implantable ventricular support system; and e. implantable drug infusion system 4. Devices of human origin a. human dura mater; and b. wound covering 67(1) Implant registration 54(1),(2) Distribution records for implants. If the Manufacturer sells a medical device in Canada that is listed in Schedule 2 of the MDR, does the Manufacturer have procedures and records that satisfy the traceability requirements of section 66? Check the implant registration card s contents against the requirement of MDR sec. 66(1). Check if the implant registration card provides for recording of the information specified in MDR sec. 66(2) Check if the implant registration card is available in both English and French (MDR sec. 66(3)) Do the Manufacturer's agents or distributors of active implantable and implantable (as defined in section 3 of :2003) maintain distribution records of these medical devices? Customer property The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall 67(3) Implant registration How does the Manufacturer safeguard the name and address of the patient, unless disclosure is required by law? Revision: 0a / / 134

12 identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4) Preservation of product documented procedures or documented work instructions for preserving the conformity of product during internal processing and delivery to the intended destination. 14 Conditions of storage and transport Are the characteristics and performance of the medical device protected during transport or storage, taking into account the Manufacturer's instructions and information for transport and storage? How does the manufacturer ensure such protection? 8 Measurement, analysis and improvement 8.2 Monitoring and measurement Feedback a documented procedure for a feedback system [see c)] to provide early warning of quality problems and for input into the corrective and preventive action processes (see and 8.5.3) (1)(a) Complaint Handling Does the Manufacturer and its Canadian importer and distributor(s) maintain records of reported problems or consumer complaints relating to the performance characteristics or safety of the medical device? Are these problem reports or consumer complaints used as input into the corrective action system? Note 1 : for guidance on complaint handling and recall see dgpsa/inspectorate/medical _devices-eng.php No specific requirement in MDR. 8.5 Improvement General documented procedures for the issue and implementation of advisory notices. These procedures shall be capable of being implemented at any time. 64 & 65 Recall (note the MDR definition of Recall includes the actions of physically removing a device from the market or notifying its owners and users of its defectiveness or potential defectiveness. See Section 1 of the MDR for official definition) 58 a) Complaint Handling Mandatory Problem Reporting Do the Manufacturer and his Canadian importer have documented procedures for them to: 1. carry out an effective and timely recall of the medical device following a consumer complaint or reported problem related to medical device performance or safety; 2. recall or correct a medical device, or to notify its owners and users in Canada of its defectiveness or potential defectiveness after becoming aware that the medical device : (a) may be hazardous to health; (b) may fail to conform to any claim made by the Manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or (c) may not meet the requirements of the Food and Drugs Revision: 0a / / 134

13 Act (R.S., c. F-27, s.1) or the MDR (SOR/DORS/98-282) Note 3 : for guidance on Product recall procedures see medical_devices-eng.php Records of all customer complaint investigations shall be maintained (see 4.2.4). If investigation determines that the activities outside the organization contributed to the customer complaint, relevant information shall be exchanged between the organizations involved (see 4.1). If any customer complaint is not followed by corrective and/or preventive action, the reason shall be authorized (see 5.5.1) and recorded (see 4.2.4). If national or regional regulations require notification of adverse events that meet specified reporting criteria, the organization shall establish documented procedures to notify the regulatory authorities. 57(1)(b) Maintain records of actions taken following reported problems and customer complaint. Section 59 to 62: Mandatory Problem Reporting Does the Manufacturer and its Canadian importer and distributors maintain records of reported problems or consumer complaints relating to the performance characteristics or safety of the medical device? Are these problem reports or consumer complaints used as input into the corrective and preventive action system? Note 1 : for guidance on complaint handling and recall see medical_devices-eng.php Does the Manufacturer and its Canadian importer have documented procedures to inform Health Canada of incidents that meet the mandatory reporting criteria found in Sections 59 to 62. Refer to the original wording of MDR sec to review these procedures. Preliminary report within 10 (30) days after the manufacturer or his distributor becomes aware of the incident, if the incident has (has not) to the death or serious deterioration in the state of health of the patient, user, or other person Note 2 : For guidance on mandatory problem reporting see medical_devices-eng.php Corrective action 58 a), b) Complaint Handling See of this checklist. Revision: 0a / / 134