Review Guideline On Biological Evaluation For Medical Devices

Review Guideline on Biological Evaluation for Medical Devices
CFDA [2007] No. 345
To Food and Drug Administration of the provinces, autonomous regions and
municipalities directly under the Central Government (Drug Administration)
In order to standardize the biological evaluation and review of medical device,
CFDA has formulated the “Biological Evaluation and Review Guidelines of Medical
Device” to be issued. Please implement accordingly, and notify the relevant matters as
follows:

I. A manufacturer applying for product registration involving biological evaluation
may provide a biological evaluation report (including supporting documents) instead of
the biological test part of product registration test report, or conduct a full biological
test.
II. If the biological evaluation report of medical device provided by overseas
manufacturer contains a biological test report, the manufacturer shall provide the GLP
certificate of the country where the biological laboratory is located.
Appendix 1 Biological Evaluation and Review Guidelines of Medical Devices
Appendix 2 The issuance and review key points of “Biological Evaluation Report of
Medical Device”
CFDA
June 15, 2007

Appendix 1
Biological Evaluation and Review Guidelines of Medical Devices
I. Purpose and scope
This guidance is formulated to enable the GB/T 16886-ISO 10993 series of standards to
be implemented correctly and efficiently.
This guidance provides a guide to biological evaluation of medical device reviewer and a
biosafety review guide for medical device review.
Note: This guidance does not cover biosafety in microbial contamination, sterilization
(e.g., “sterile”, “bacterial endotoxin”), degerming and virus removal and control of
animal-derived medical devices.
II. Terms
(i) Medical devices: Same as the Regulation on the Supervision and Administration of
Medical Devices.
(ii) Manufacturer: Medical device manufacturer or trademark holder/unit.
(iii) Evaluator: The manufacturer of medical device or the expert entrusted.
Note: Medical device manufacturers are responsible for biosafety evaluation.
(iv) Reviewer: The administrative department that has the responsibility for the
management of medical devices or the institution that is entrusted with medical device
review.
III. First biosafety evaluation of medical device / material
(i) Evaluation basis
GB/T 16886-ISO 10993 “Biological Evaluation of Medical Devices” series of standards.
(ii) Evaluator
He/she should be trained and have long-term practical experience in the biologic
evaluation of medical device.
(iii) Evaluation requirement

1. For the purpose of protecting humans, medical devices that require biological
   evaluation, and clinical trials shall not be conducted before biological evaluation
   (especially necessary animal tests).
2. When conducting biological evaluation of medical devices, it shall be carried out in
   accordance with the evaluation flow chart given in GB/T 16886.1-ISO 10993.1.
3. Evaluators should focus on the use of existing information (including materials,
   literature, in vitro and in vivo test data and clinical experience) in the process of
   biological evaluation, and should not be restricted to biological tests.
4. When the biological evaluation is confirmed that a biological test is required, a test
   institution with the corresponding biological test qualification should be entrusted to
   carry out the test.
5. When conducting a biological test, it should:
   (1) Perform an in vitro test before conducting an animal test;
   (2) Make full and reasonable use of experimental animal resources as required, optimize
   the test protocol, and reduce the test cost.
6. The “Biological Test Report” should be issued in accordance with the requirements of
   the report in accordance with the GB/T 16886-ISO 10993 series of standards.
   Note: The biological test report may not be issued together with the type test report.
7. The Biological Evaluation Report may consider (but is not limited to) including the
   following:
   (1) Strategies and procedures for the biological evaluation of medical devices;
   (2) A description of the material selection for medical device;
   (3) Material characterization

• Qualitative and quantitative description or analysis of medical device materials
• Equivalence comparison of medical device materials and predicates on the market
  (4) Reasons and arguments for selecting or abandoning biological tests;
  (5) Summary of existing data and test results;
  (6) Other data required to complete the biological evaluation.
  IV. Biosafety reevaluation of medical device
  (i) Manufacturers should consider reassessing biosafety under the following
  circumstances:

1. When the source of materials or technical conditions used to manufacture the
   product changes;