FDAnews Announces — Dealing with Chinese Medical Device Regulatory Authorities: Insider Tips from a China Expert Webinar, April 19, 2017

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There has been an explosion of new and revamped regulations for medical devices in China. Jason Ma, a leading authority on China medical device regulation, will break it all down in one 90-minute webinar.

Dealing with Chinese Medical Device Regulatory Authorities:
Insider Tips from a China Expert
**An FDAnews Webinar**
April 19, 2017 — 1:30 p.m. – 3:00 p.m. ET

China’s “FDA ” is 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 a Chinese puzzle. Devicemakers can’t hope to get a registration approved without a knowledgeable and trustworthy local guide.

But how do they find such a guide? Which regional or local agencies must manufacturers deal with and which can be safely ignored? Do manufacturers still need to obtain marketing authorization from their home country, or has that onerous requirement been abolished under new regulations?

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.

Attend this webinar to 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 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.

Meet the Presenter:
Jason Ma Esq., 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.

Who Will Benefit:

  • Medical Device Presidents and CEOs
  • Regulatory Affairs Management
  • Clinical Affairs Management
  • R&D Management
  • CRO executives

Webinar Details:
Dealing with Chinese Medical Device Regulatory Authorities:
Insider Tips from a China Expert
**An FDAnews Webinar**
April 19, 2017 — 1:30 p.m. – 3:00 p.m. ET

$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/chinamdreg                                        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
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