Newly Proposed Amendment to the Medical Device Regulation “Supervision and Administration of Medical Devices”
Today (Oct. 31, 2017) CFDA released a proposed amendment to the current Medical Device Regulation, which is the medical device law officially released in 2014. The proposed amendment has been released and is open for public comments for the next two weeks.
The proposed changes relevant to international companies are as follows
(The author has added her own personal opinion on these changes in italics after each entry, which are for discussion purposes only.) :
- Defining the responsibility of the China Agent for international companies, as to assist communication with CFDA, participate and report adverse event or recall activities, share responsibilities with the manufacturer for product defects or violations.
This definition further clarifies the confusion between the Legal Agent for regulatory and the Distributors for sales of products, confirming that the Legal Agent is for regulatory work only, not necessarily for product sales.
- Softening the requirement for product testing, including self-testing by the manufacturer or by a contracted testing facility.
This clause removes the mandatory requirements of in-China testing for Class II and III products, opening doors for other opportunities for product testing, which would benefit the manufacturers in terms of shorter time and less cost.
- Softening the clinical requirements for Class II and III products, allowing non-clinical evidence ahead of clinical trial.
The change is moving toward the generally accepted guidelines internationally that non-clinical evidence should be considered before a human/animal trial is used.
- Accepting overseas clinical data for Class III high risk products.
This change is major for international companies. However companies need to be sure that its global trial includes Chinese or Asian patients.
- Accepting self-testing reports or by a testing facility for innovative products.
This change is in line with the renewed commitment by the Chinese government to encourage innovations and new technologies.
- Strengthening post market surveillance and a penalty clause for violations.
This major enhancement is aimed at tightening control on products on the market. Violations will be penalized, including the manufacturer being banned from the Chinese market for two years.
The above are preliminary and for the time being. As we learn more and understand the essence of these changes, we will update our findings via our blog and twitter. So please stay tuned.