China FDA issues device guidelines, highlights training for inspectors

China flag

China FDA has released a slew of new standards for medical devices as it ramps up training of inspectors to oversee the industry.

In a notice in early May, China FDA said it had released 186 industry standards under two orders covering medical devices, which include 42 mandatory guidelines and 144 recommendations for the industry.

The guidelines cover everything from implants and disinfectant procedures to equipment across specialties such as dental and ophthalmic tools.

“The promulgation and implementation of these standards will further improve China's medical device standards system, and build a solid foundation for ensuring the safety and effectiveness of medical devices and protecting the health of the public,” CFDA said in a statement.

The regulator has also said it has completed the first round of a continuing education program of medical equipment inspectors, which includes certificates covering a range of subjects such as good manufacturing practices, and also included discussions with unspecified regulators from abroad.

- here's the China FDA release on device standards
- and the China FDA notice on the device inspector training (in Chinese)


Suggested Articles

Hospital-backed Civica Rx has struck a deal for a CDMO to help it develop its own brand of drugs, for which it will own the rights.

Hengrui's Sun Piaoyang is stepping down as chairman, but he'll retain control of the pharma major he's headed for 30 years—and made a fortune…

Astellas tapped Adaptimmune to develop T-cell therapies. Ireland hit Takeda with an unexpected Shire tax bill. PD-1 med Tyvyt hit its goal in NSCLC.