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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:
Jason Ma Esq., Attorney, Mei & Mark LLP.
Mr. Ma practiced medicine in Guangzhou before being admitted to the Chinese bar in 1992. He is a former law partner of a Guangzhou firm and a senior attorney with leading international law firms in Hong Kong. He now practices law in Washington DC, specializing in assisting U.S. devicemakers and CROs navigate the pitfalls of the unfamiliar but lucrative Chinese market.
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