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.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

“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

As AZ and FibroGen have yet to submit the novel anemia drug to the U.S. regulators, national reimbursement talks are already underway in China.

Neopharma, which has been buying and building plants for several years, is buying a sterile injectables plant and assets in Japan from India’s Lupin. 

In a warning letter, the FDA details how a Chinese OTC drugmaker handed over documents faked just for the agency's inspection—and admitted it.