China Regulation Updates from the month of May

1. The implementation of Periodic Risk Assessment Report for Adverse Events

To further implement the Administrative Measures for Monitoring and Re-evaluation of Adverse Events of medical devices (NMPA order No. 1), NMPA publish a guidance requiring device manufacturer to provide an annual adverse event assessment report.  For Class II and class III devices, which stay in their 1st initial registration cycles until 1st January 2020, the legal manufacturers must provide the report retrospectively to year 2019, plus report for year 2020 to NMPA no later than 30th September this year.  For class I devices, the legal manufacturers shall draft such reports internally for 5 years since approval and make them available to NMPA at request.  The former State Food and Drug Administration guidelines for adverse event monitoring of medical devices (Trial version) was abolished.

2. Pre-review channel for answering deficiency letters with CMDE

When receiving the notice of supplement and correction notice from CMDE technical reviewer (deficiency letter after submission acceptance), the applicant has one-year time to provide all the supplementary answers with only one opportunity.  A standard way is to book online consultation or face-to-face on-site consultation to discuss the interpretation and prepared answers with the reviewer before the formal submission.  Now the applicant is given an additional chance to let the reviewer check the intended answers 2 months before the one-year deadline.  The purpose is to ensure that the supplementary files indeed meet the review requirements, and applicant still have time to close the gaps or prepare additional required files before official submission.  This pre-review channel is optional, and the applicant may consider at their own discretion.

3. CA certificate can be renewed online

To practically help the Chinese companies to renew their CAs on time and continuously use them for ERPS submission, NMPA launch online service to replace the previously on-site renewal requirements to avoid unnecessary travels during corona virus times.  Most of the enterprises across China successfully renewed their certification on time and think highly of this considerate alternative.

4. NMPA publish Notice on Issuing the Evaluation Guidance for changes in raw materials of Non-active medical devices

The change of selected materials, parts and spare parts may affect the safety and effectiveness of medical devices, so the possible risks caused by these change shall be evaluated, and measures shall be taken to reduce the risks to an acceptable level if necessary by manufacturers.  NMPA is guiding the manufacturers to standardize their product design and development, registration application and quality control when the applicable changes happen, and also to guide the regulatory authorities to conduct technical review of registration application caused by changes in raw materials of passive medical devices

5. NMPA is asking comments on Guidance for Technical Review of Human Factors Design of Medical Devices

The guidance is applicable to class II and class III devices.  The purpose is to support medical device industry consider or improve human factors and usability engineering processes appropriately to ensure products’ safety and effectiveness for the intended users and use environments.  With the trend of converging with international harmonization, the guidance also refers to western standards and guidance’s, such as IEC 62366 Medical devices - Part 1: Application of usability engineering to medical devices, IEC 60601-1-6 General requirements for basic safety and essential performance - Collateral standard: Usability, and FDA guidance on Applying Human Factors and Usability Engineering to Medical Devices.

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Stephanie (Xing) Huang
Post date: June 01, 2020
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