Riding the New Wave: How to Prepare Your Medical Device Company for Compliance and Success in China

Practices: Life Sciences, China Life Sciences, FDA Regulatory

 

Program Description:

China is one of the most important strategic markets for many medical device companies, but navigating its rapidly changing regulatory environment does not come without challenges. The Chinese government recently amended the Medical Device Regulations with substantial changes to the regulatory framework and philosophy. To seize opportunities in China, companies must ensure they stay in compliance with these new rules and develop practical commercial strategies to address them.

China is also a major source of manufacturing for medical device companies of all sizes. A number of challenges are presented in working with Chinese suppliers, including negotiating quality agreements, ensuring GMP compliance, and managing regulatory inspections.

Ropes & Gray, together with MassMEDIC, invites you to participate in this panel discussion, followed by a moderated Q&A session, that will address these topics and the opportunities and risks they present. Specific areas of discussion will include:

• The State Council's recent amendment of the Medical Device Regulations;
• The China Food and Drug Administration (“CFDA”)'s proposed changes in relation to device marketing authorization, Good Clinical Practices, Good Manufacturing Practices, and Good Supply Practices;
• The reforms led by other Chinese government agencies in relation to pricing, reimbursement and tendering of high value medical consumables;
• Import/export and regulatory compliance issues in relation to partnering with Chinese companies or working with Chinese manufacturing facilities within a multinational organization

Speakers:

Katherine Wang

Gregory H. Levine

Judith K. Meritz

For questions regarding this seminar, please contact rgevents@ropesgray.com

 

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