December 11, 2018

In early November, NMPA has issued a draft of the guideline entitled, “Biological Evaluation for Medical Device Part 1: General Principles (hereinafter referred to as “the Guideline”) and has sought comments from stakeholders. This guideline aims to supplement GB/T 16886.1-2011 "Biological Evaluation of Medical Device Part 1: Evaluation and Testing in Risk Management Process" (ISO10993.1:2009) in able to assist the manufacturer in the registration application of medical devices.

The guidance includes eight (8) annexes applicable to the biological evaluation of both sterile and non-sterile medical devices that would directly or indirectly contact with the human body. For specific types of instruments, the manufacturer shall still follow the specific national standards. For example, the dental instruments shall consider the YY/T 0127 – The Biological Evaluation of Medical Devices for Oral Use.

This guideline contains the following:

1. Risk management plan for biological evaluation;

2. The process of biological evaluation: This section contains the biological evaluation endpoints recommended by NMPA, and the biological evaluation flow charts to describe the overall process;

3. Definition of technical terms used in the guidelines;

4. The biological evaluation information recommended to be included in the device master file;

5. For biocompatibility testing, NMPA will soon mandate manufacturers to submit a summary of biocompatibility results between the control sample and actual product presented as a comparison table. Alternatively, the manufacturer may provide a summarized biocompatibility report comparing results for the actual device to its predicate device sold in China. NMPA shall issue a prescribed format for the comparison table;

6. NMPA will soon require manufacturers to submit protocols for document searching, and will be recommending general processes and file formats for document retrieval;

7. NMPA shall attest to the information indicated in the biocompatibility test report;

8. NMPA will be issuing a template containing a tabular overview of biocompatibility information. All applicants shall include these prescribed templates for biocompatibility test reports and information in the registration dossier.


Qualtech’s Suggestion:

Upon close study of the drafted guideline, it was found that the first half of the contents of the contents thereof are similar to ISO10993-1:2018. Although Annex 4-8 will be published next year, it is predicted that the content will also be similar as ISO10993-1:2018. It is recommended that manufacturers use ISO10993-1:2018 as reference for the biological evaluation in product design and development in the future, especially in the development of implantable or blood-contacting products to ensure smooth compliance to Chinese registration requirements.



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