CFDA Updates

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 China 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 […]
May 25, 2017

CMD Hails CFDA’s Policy Reform Initiative

We are monitoring closely the current initiative taken by CFDA to reform its registration and regulatory policies and believe this reform should positively impact medical device entry to China by US and international medtech companies:

On May 11, the CFDA released three documents for public comment aiming to reform clinical trial management; accelerate review and approval process; and implement full life-cycle management; for encouraging pharmaceutical and medical device Innovation. These three documents mark a big step forward for the CFDA in reforming the registration system for pharmaceutical and medical devices and reflect some of the major issues that the industry has been advocating on for decades. On May 12, the CFDA further released Policies on Protecting Innovator’s Interests for Encouraging Pharmaceutical and Medical Device Innovation, to establish a pharmaceutical patent linkage system and improve test data protection system. The systems and measures proposed in this draft provide more detailed regulations for enforcing existing measures, showing the CFDA’s determination in further strengthening IPR protection and creating an atmosphere that rewards innovation...

May 25, 2017

CFDA Update: Actions Taken to Deepen Registration Reform

In this month, CFDA released three documents for public comment: 1) Policies on Reforming Clinical Trial Management for Encouraging Pharmaceutical and Medical Device Innovation; 2) Policies on Accelerating Review and Approval Process for Encouraging Pharmaceutical and Medical Device Innovation; 3) Polices on Implementing Full Life-Cycle Management for Encouraging Pharmaceutical and Medical Device Innovation. According to the CFDA, these three documents aim to further deepen registration reform, promote industrial upgrade and innovation in the pharmaceutical and medical device sector, and meet increasing clinical needs. 

Contact China Med Device (CMD) team if you would like to know more about CFDA's registration and policy reform and get immediate help to accelerate your device's market entry in China. Please call us 978-390-4453 or email info@ChinaMedDevice.com.

Click here to find out more about CMD's turn-key China regulatory services for your medical device.