China’s Medical Device Regulations - Webinar CD/Transcript
China’s Medical Device Regulations: Keys to Selling More in a Hot Market
China, the hottest medical device market on the planet, is welcoming U.S. devicemakers. A push is on to streamline importation of medical devices, including letting U.S. drugmakers set up production in China and collaborate with local manufacturers.
The price is a familiar one: Compliance with China’s regulations. They’re complicated, and — no surprise — changing fast.
Looks like time to call a lawyer. A China specialist, specifically — one who spends every working day with Chinese device regulation on behalf of clients like you. Or better yet...
Over 90 information-packed minutes, John Balzano Esq. of Covington & Burling’s New York office will guide you through China’s regulatory maze, including changes to GMPs, self-inspections, foreign inspections, and enforcement actions and campaigns. In recent months, China’s FDA (CFDA) has taken the following actions:
- Proposed a new medical device classification catalogue
- Set forth priority and expedited pathways for devices to serve unmet clinical needs
- Issued regulations on device clinical trials, procedures and positive lists for applying for exemptions from the in-country clinical trial requirement
- Made moves affecting post-marketing surveillance, including new recall regulations and proposals for new adverse event regulations
- And much more.
Don’t turn your back on a nation of 1.4 billion and an economy growing nearly 6.7% a year. Learn the China rules ... and get your share of the China market.