After a major overhaul in 2014, the CFDA “Regulations on the Supervision and Administration of Medical Devices” have been focusing on registration quality management system verification with higher requirements, compared to the original device quality management system assessment procedures.
In the current CFDA approval process, because registration verification is the last check of the quality management system verification before the medical device is put on the market, the CFDA has a great responsibility to verify the authenticity of the site. Therefore, the registration verification process has in its protocol a one-vote veto rule for the successful registration of medical devices. Regardless of how all other information and data is prepared, if even one after this vote is a vetoed, device companies will need to re-apply for registration, thus wasting valuable time and cost.
Key Items Are Keys
There are more than 200 provisions in the 4 guiding principles of “Good Manufacturing Practices for Medical Device Production” and related appendices. If any one of the key items with “*” sign does not meet the requirements, it means you “failed the inspection.” For other non-critical items, when you have 3 to 5 items that fall below the requirements, the CFDA will give you the conclusion of “review after rectification.”
Repeat: if your product failed on one key item, the entire application for registration will be abandoned and you will need to restart the approval process.
With the CFDA, most device manufacturers are prone to problems in the following areas:
- Misunderstanding the terms, such as not paying attention to the production address information, having environmental monitoring report approved, the technical requirements did not leave the factory testing and type testing;
- Issues in information declaration, such as the declaration of product development and manufacturing address not being clear, declare the product has not yet completed the design and development, do not have the appropriate production conditions, the hardware there are serious shortcomings;
- Non-conforming items were found during on-site inspection. For example, quality management system can not meet product risk management, lack of effective control over design and development, and lack of substantive R & D activities.
Focus on Systematic Product Quality Management
Many start-ups only pay attention to the production technology itself, while ignoring the establishment of quality management system, the lack of professional quality system managers, management system loopholes.
We strongly advise device manufacturers to record all supporting documents of the system and take part in the whole life-cycle management of the product from research and development, clinical and manufacturing, to adverse reaction monitoring after listing, follow-up and product recall.
Work With Field Experts
Due to the complexity of the CFDA registration and approval process and the high-cost and time delay were your product is not approved in the first round, we also advise overseas manufacturers to consult and work with field experts such as China Medical Device team who are familiar with CFDA device registration and approval procedures to expedite their devices’ approval in China.