China CFDA is proposing to allow the Center for Drug Evaluation (CDE) and Center for Medical Device Evaluation (CMDE) to directly approve some submissions, without requirement for final review and approval by the CFDA. This will speed up approvals for some submissions from both local manufacturers and importers. It’s another step in streamlining the Chinese regulatory bureaucracy and lessening of centralised control.
With more and more medical devices containing animal sourced materials, China’s CFDA is strengthening its Technical Guidance for animal derived biomaterials.
After identifying that their current classification catalogue contained a number of deficiencies, the CFDA have release a draft document to update the catalogue first issued in 2002. The update is significant, and a move to categorise devices by functionality and clinical application is likely to improve the practical application of this classification catalogue and serve to update their regulations to better reflect the current state of the medical device market.
Joint Chinese agencies have released the ruling for the China ROHs 2.0, Restriction of hazardous substance in Electrical & electronic products effective 1st July, 2016. A product list for mandatory compliance will be published shortly. In summary, products listed that contain specific Hazardous substances must be below the prescribed limitations, however products not included in this mandatory compliance list may exceed the limits if they comply with the required labeling.
China’s CFDA has released a draft proposal for fast track review of submissions which bring new technologies to areas of clinical priority or current unmet needs. Devices which address national research priorities, cancer, pediatrics or geriatrics or any area with a currently unmet clinical need stand to get priority review.
CFDA has just published two new draft lists out for consultation… Revised articles to Order No. 650 & Exemption list of Class II & Class III device for local clinical study – Wave 2. Read more.