Dealing with Chinese Medical Device Regulatory Authorities - Webinar CD/Transcript
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Dealing with Chinese Medical Device Regulatory Authorities: Insider Tips from a China Expert
Doing business in China, or planning to? Here’s our best advice:
Forget everything you know.
Take China’s “FDA.” It’s an FDA in name only, principally in charge of marketing authorization. Actual device regulation is carried out by regional and local governments ... of which there are more than three thousand.
To American eyes, the Chinese regulatory system is ... well, a Chinese puzzle. You can’t hope to get a registration approved without a knowledgeable and trustworthy local guide.
But how do you find such a guide? Which regional or local agencies must you deal with ... and which can you safely ignore? Do you still need to obtain marketing authorization from your home country, or has that onerous requirement been abolished under new regulations?
Face it: You need expert help. And we’ve got just the expert to help you.
Jason Ma Esq. started his career practicing medicine in a Guangzhou hospital. In 1992, he passed the Chinese bar and joined a Guangzhou law firm specializing in medical device and other healthcare regulation. Later he moved to Hong Kong where he represented international device clients seeking success in the mainland-China market. And now he has landed in the Washington DC office of Mei & Mark LLP where he represents and guides clients like you.
Attend this session and discover:
- How to comply with arcane Chinese device rules. Example: Under new regulations, are medical devices imported into China no longer required to obtain marketing authorization from their "exporting countries”?
- Tips for gaining market approval, including how to find a trustworthy domestic agent to submit your applications to the China FDA and other agencies.
- What Chinese regulatory authorities look for under a hybrid system where marketing authorization is granted by China’s “FDA” but local/regional governments enforce relevant regulations.
- How to avoid enforcement actions — the unexpected things Chinese regulators may look for during inspections.
- How Chinese regulation works — how China’s agencies function, how they relate to one another, what to prepare for in person-to-person interactions.
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