China’s NMPA Proposes Elimination of Country-of-Origin Approval Requirement for Medical Devices

The National Medical Products Administration (NMPA) in China has released a draft Medical Device Administrative Law (MDAL) and is soliciting comments from stakeholders. The MDAL is a novel promulgation in China. A notable proposed change is the elimination of the existing country of origin approval for imported medical devices to China, except for innovative devices. Currently, medical devices need to first be registered in the home market where the device was made, before obtaining China approval. This situation has made it difficult for many foreign companies to export their devices to China. The proposed MDAL would permit medical devices to simultaneously undergo regulatory evaluation and regulatory approval in a foreign country at the same time as in China. This proposal would, if implemented, significantly accelerate the time to enter the China market.

In addition, the NMPA emphasizes compliance with China’s compulsory product standards. The proposed MDAL has new specific information on the required mandatory standards. In some cases, in contrast to the West, China has used these standards to hinder market entry. The proposed MDAL increases civil penalties for non-compliance, especially for high-risk implants, and increases the liability of the local legal entity or marketing authorization holder. Also, if companies initiate changes to their registered products and do not submit the appropriate change notifications (or in some cases, do not do new registrations), the fines have been dramatically increased and the local agent and company executives may be personally liable. Finally, the proposed MDAL imposes stricter post-market requirements and prohibits the use of refurbished medical devices in hospitals. Stakeholders are encouraged to review and provide comments on the draft MDAL by late September.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)