Pre-market Information - Class III and IV

Transcription

1 Pre-market Information - Class III and IV Life Sciences Council British Columbia NRC Industry Research Assistance Program Vancouver, October 29, 2007 Mary-Jane Bell, Ph.D. Medical Devices Bureau (MDB) Therapeutic Products Directorate (TPD)

2 Overview Safety and Effectiveness Requirements Premarket Review Document Class III Class IV Special Cases

3 Licensed Medical Devices Medical devices licensed under Part 1 of the Medical Devices Regulations (MDR) represent the vast majority of medical devices sold in Canada. All these medical devices must meet the safety and effectiveness requirements set out in Sections 10 to 20

4 Manufacturer Obligations Licensed Devices Part 1 of the MDR detail the obligations and responsibilities of manufacturers and importers of medical devices who sell medical devices in Canada. These are inclusive of premarket, postmarket and quality systems responsibilities.

5 Medical Device Licence Applications Class III and IV As part of the medical device licence application for Class III and IV devices some evidence supporting safety and effectiveness is required. More premarket evidence is required for a Class IV device, relative to a Class III medical device.

6 PREMARKET REVIEW DOCUMENTS Required for Class III and IV medical devices. The premarket review document contains the objective evidence required to determine if the device licence application or amended device licence application meets the safety and effectiveness requirements of the Regulations. A guidance document prescribes the format and content of this file.

7 Medical Device Licence Applications In order to obtain a medical device licence, a manufacturer is required to submit information to Health Canada to demonstrate that the medical device in question is safe and effective. The safety and effectiveness information provided by each manufacturer is confidential and proprietary to their own product. It cannot be used to support products manufactured by another entity. Information from the peer-reviewed, publicly available scientific literature can be used as appropriate to support the safety and effectiveness of any medical device.

8 Class III Premarket Review Document Background Information: Device description, including design philosophy Marketing history Safety and Effectiveness List of standards, declaration of conformity Summary of all studies relied upon Validation procedures and results Labelling

9 Background Information Device Description - general description of the device and the materials used in its construction and packaging. Principles of design - description of the features, including performance specifications of the device that permit it to be used for its intended purposes. Marketing History - information on regulatory status, problem reports, recalls and known sales volumes in major world markets.

10 Safety and Effectiveness (1) List of Standards Manufacturers are requested to supply a list of standards complied with during the design and manufacture of the device to satisfy the safety and effectiveness requirements. A declaration of conformity in accordance with the Standards Policy can be provided for MDB recognized standards, to minimize the data reporting requirements.

11 Safety and Effectiveness (2) Summary of studies relied on to ensure the medical device meets the safety and effectiveness requirements: Is dependent upon the device in question, might include biocompatibility, electrical safety, mechanical strength and potential clinical evidence of effectiveness. Must include sufficient detail as to how the testing was conducted, the results obtained and most importantly the conclusions drawn by the manufacturer. Bibliography specific to the device in question.

12 Safety and Effectiveness (3) Validation processes and results to establish the safety and effectiveness of the device. Including but not limited to: Sterilization validation Software design validation Calibration processes, etc.

13 Labelling Labelling must comply with Sections 21 to 23 of the MDR. Label is defined in the Food and Drugs Act and includes any legend, word or mark attached to, included in, belonging to or accompanying a device or package. Labelling claims must be supported by the evidence of safety and effectiveness supplied.

14 LABELLING (2) The final labelling text must be submitted for review, including: inner and outer labels; package inserts; product brochures; and, information and instructions for use. There are two labelling guidance documents available from TPD, one for general medical devices the other for in Vitro diagnostic devices.

15 Class IV Premarket Review Document The following are the same as a Class III application: Background Information: Device description, including design philosophy Marketing history Safety and Effectiveness List of standards Validation procedures and results Labelling Summary of studies is replaced with specific device requirements.

16 Class IV Premarket Review Document The safety and effectiveness of Class IV medical devices must be supported by the following: Manufacturing and quality control processes and procedures, including a quality plan; Risk assessment; Complete material specifications; Preclinical test methods, results, analysis and conclusions, and; Clinical results, including protocols, results, analysis and conclusions.

17 Manufacturing Information Manufacturing methods Quality plan, or outline of manufacturing processes including key checkpoints Packaging methods and materials Sterilization methods, including validation Supported by a valid certificate of compliance to CAN/ISO

18 Material Characterization Identification of all component materials by name and % of final product. Bulk properties, raw material acceptance criteria Mechanical, physical and chemical properties of finished products Identification of catalysts, cross-linkers or terminating species

19 Risk Assessment The Regulations require manufacturers prepare a risk assessment including: an analysis and evaluation of risk Risk reduction methods employed A risk assessment should compare the results of using a device with alternate or no treatment options.

20 Preclinical Testing The type of preclinical testing required is dependent upon the device in question, but may include: Mechanical and Physical Testing Biocompatibility, including toxicity Degradation studies to determine device longevity Complete methods, results, analysis and conclusions should be presented.

21 Clinical Evidence Evidence of effectiveness can be demonstrated in a number of ways, each with its own strengths and weaknesses. Prospective clinical trial. Retrospective review of clinical data. Clinical review of the literature, relevant to the device in question with analysis and conclusions presented.

22 Special Cases (1) Medical devices containing biological materials. Specific policies and guidance documents available addressing the risks of transmissible disease. Use of bovine, caprine and ovine materials only from countries certified as BSE free by CFIA. Donor selection issues and viral validation processes are carefully reviewed for devices containing human materials.

23 Special Cases (2) Combination products regulated as medical devices. Currently developing and/or updating policies and procedures in this area. These medical device licence applications may involve a review team, and may take longer to finalize.

24 Special Cases (3) Near patient in vitro diagnostic devices, which by definition are used outside of a laboratory setting. These medical device licence applications must be supported by prospective clinical data conducted with the intended user population, and under conditions of use similar to those claimed.

25 Health Canada s Review Process Are these tests sufficient to establish that the device will not adversely affect the health or safety of a patient? OR Is a possible adverse effect, an acceptable risk when weighed against the benefits to the patient?

26 Health Canada s Review Process (2) Are additional tests required to establish safety? Are additional warnings and precautions required for any remaining risks? Should risk be determined based on finished product testing or raw material characteristics? Or both?

27 Review Outcomes There are three (3) potential review outcomes: Licence Licence with conditions Refuse to licence

28 Post Licensing Requirements Compliance with any licensing conditions. Mandatory problem reporting. Complaint handling, distribution records and recalls. Implant registration (if applicable). Obligation to inform, or licence renewal. Apply for medical device licence amendments as appropriate.