Whether China unfairly discriminates against foreign companies is always a subject of controversy and debate. In the case of the medical device industry, the Chinese government has started encouraging even high-end hospitals to use devices made and designed by local competitors.
But China's registration review process for imported medical devices and in vitro diagnostics has been shortened under new China FDA (CFDA) importation regulations that took effect last month. Be warned, companies that fail to follow the guidelines will not get a second chance at submitting documentation, meaning any mistakes could prove fatal to a product's chances in China, under Administrative Order No. 208, according to an article in Regulatory Focus, a publication affiliated with the Regulatory Affairs Professional Society.
In another industry-friendly move, Registration Certificates for Medical Devices are now valid for 5 years instead of the previous 4 years. Although the process for licensing and reviewing medical devices is now expected to take three to four months, applications must still be filed 18 months prior to the targeted date of commercialization because companies need time to respond to the government's requests. Renewal applications must be submitted 6 months prior to the expiration of the registration certificate, Regulatory Focus says.
China has a three-class, risk-based regulatory classification for devices, similar to the FDA. China specialist and regulatory consultant Mingzi Deng, author of the Regulatory Focus article, said her clients' total review time is typically 6 to 8 months for Class I and 12 to 18 months for Class II and III devices. Recently, some devices have been upgraded from Class I to Class II, according to the article.
There are four steps to the process of licensing and registering imported medical devices in China under the new rules.
First, the CFDA will review the format of the filing, which must be submitted both electronically and on paper. The subsequent technical review period lasts two to three months. Companies are given a year to respond to any flaws noted by CFDA. The third step is the administrative evaluation, which takes 20 days, at the end of which a final decision is made. Ten days after that, expect an official Registration Certificate for Medical Devices or a denial letter explaining the decision, according to Regulatory Focus. Rejected applicants can apply for reconsideration within 60 days.
Some of the application requirements include product performance, biocompatability, and sterilization studies; a description of the manufacturing process and site; a report on product type-testing conducted in China; and sample labeling.
Regulatory Focus says that the process is subject to negotiation with the reviewers. The regulation is posted in Mandarin on the CFDA website.
Many believe that Medtronic ($MDT), Johnson & Johnson ($JNJ) and other industry bigwigs can score some points with the government by making their for-China products within the country, and the new regulations are unlikely to change that. Rules mandating more local clinical trials for higher risk devices also took affect in October. For foreign or imported devices, trials done abroad may be insufficient, potentially giving Chinese companies an advantage.
Highlighting the growing importance of the Chinese med tech market, AdvaMed CEO Stephen Ubl joined leaders of the CFDA and other Chinese government agencies, as well as industry representatives, at the official opening yesterday of the trade association's office in Shanghai. The ceremony was held in the capital of Beijing and included U.S. embassy officials, further demonstrating the key facilitative role played by the governments of both countries.
- read the Regulatory Focus article (sub. req.)
- here's the AdvaMed release
Editor's Note: This article has been updated to include comments from the Regulatory Focus piece's author.