CFDA Updates

June 6, 2017

CFDA Updates: Draft of “Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents” Issued, Along with the 2nd Batch of Clinical Exempt Class II IVD Reagents

On May 24,2017, CFDA issued the draft of “Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents”. The 2nd batch of clinical exempt class II IVD reagents (130 reagents) have […]
June 6, 2017

CFDA Updates: Clinical Evaluation Requirements for Clinical Trial Exempt IVD Reagents (Draft)

According to Article 29 in the “Administrative Decree for the IVD Reagents Registration” (CFDA, No. 5), the clinical exempt IVD reagents will need the clinical performance evaluation based on the assessment of products’ intended use, interference factors, comprehensive literature review and other non-clinical-trial methods.

May 31, 2017

CFDA Update: More On Overseas On-site Inspections

Under CFDA Guideline Nos 14 and 218 issued in 2015, China targets sterile devices, implant and IVDs for overseas onsite inspection for registration and issuing manufacturing permit, including change order […]
May 30, 2017

CFDA New Medical Device Classification Directory Will Be Released Soon

medical device classificationOn May 11, 2017, the Standards Regulation Center in Beijing organized a meeting on how to prepare training materials for the new and pending release "Medical Device Classification Directory". The leaders from CFDA and the Standards Regulation Center along with the responsible people for the sub-directory revised work units, more than 50 people attended the meeting. CFDA commissioner, Wang Lanming, attended the meeting and talked about the importance of thoroughly prepare the training materials for the implementation of the new Medical Device Classification Directory.

CFDA "Medical Device Classification Directory (revised) " was issued for feedback with due date on November 25, 2016.

The revised medical device classification directory has significant implications for medical devices registrations or renewals. If your devices are not included in the revised directory, you must go through the expert panel forum to get the proper classification. Expert panel could be time-consuming and costly

This newly released revised draft directory has been in the works for the past seven years. It was finally released for industry feedback. The previous directory was released in 2002. It is very dated and lacks details and clarity. It fails to keep up with the rapid proliferation of medical devices and the growth of complex technologies that have taken place in China.

The revised directory has 22 subdirectories. It consolidated and reduced the 2002 version’s 43 subdirectories by 19. Under each of the 22 subdirectories, there are further detailed divisions. Here are a few examples of how to look at the categories.

May 25, 2017

Chinese Premier Signed a State Council Order for the Modification of Medical Device Regulation Policy

China’s Premier Li Keqiang just signed the State Council Order No. 680, announcing the Decision on Modification of “Medical Device Regulation Policy” by the State Council, effective immediately. The State […]