Global Regulatory Pulse

CFDA Provisions for Medical Device Adverse Event Monitoring and Re-evaluation

In Asian Market, Regulatory by Dr. Jiechen Yin

Recently, the CFDA drafted the document “Provisions for Medical Device Adverse Event (AE) Monitoring and Re-evaluation” to assist in providing guidance for medical device AE monitoring and re-evaluation. This draft, in accordance with Regulations for the Supervision and Administration of Medical Devices, is now open for comments and opinions from the public until November 30, 2016.

Background

The Provision for comment is divided into three categories: general principles, responsibilities and reporting/evaluation. All three areas are focused on monitoring, re-evaluation, disposal, supervision/administration, and legal responsibilities.

The Provision clearly states that individuals in the People’s Republic of China engaged in medical device production, operation and use of activities and supervision and management, should abide by the present Measures. The State shall implement the system of monitoring and re-evaluating AEs of medical devices and encourage citizens, legal persons and other organizations to report medical device AEs.

The main difference between the current Provision and the proposed version surrounds the National Technical Institution assuming technical work of medical device AE monitoring and re-evaluation nationwide. The Institution is responsible for clarification of medical device manufacturers and distributors, and consumption of unit responsibilities.

The draft Provision also refers to reporting and evaluation of Class II and III medical devices and the submission of post-market periodic risk assessment reports once a year, based on the date of approval for product registration – and, until expiration of the product registration certificate.

Supervision/administration and legal responsibilities are new sections in the proposed version as well. Specifically, medical device manufacturers shall be given disciplinary warning and ordered to make corrections within a specific time limit, and may be imposed a fine of no less than RMB 5,000, not to exceed RMB 20,000. Fines would be imposed by local food and drug regulatory authorities at county level or above. Medical device companies with serious situations shall be ordered to suspend manufacturing and stop business in accordance with relevant provisions in Regulations for the Supervision and Administration of Medical Devices until the relevant license is cancelled by the original issuing authority.

All sectors of society may propose opinions and suggestions related to this draft guidance by visiting the website of the Legislative Affairs Office of the State Council P. R. China (click here). Upon entering the website, submit “System for Collecting Opinions on Draft of Laws and Regulations” on the left side of home page to provide feedback. The CFDA will accept submissions until November 30, 2016.

Authors:

Dr. Jiechen Yin joined NAMSA China in June 2016 as Medical Writer, responsible for composing Clinical Evaluation Reports (CERs) and other essential documents. Dr. Yin has 8 years of R&D experience in the field of medical device in academia, and worked as a Collaboration Scientist and Product Manager in Siemens Healthcare. She received her Ph.D. degree in Biomedical Engineering from University of California, Irvine.