Era of transformation: 2018 NMPA (CFDA) Major Regulation Updates

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Era of transformation: 2018 NMPA (CFDA) Major Regulation Updates

Do you know the NEW Registration Holder System for Medical Devices in China?
Do you know the NEW post-market surveillance requirements in China?
Do you know the latest clinical requirements in China?
Do you have a plan in place for all the NEW changes in China?

 

Join us for this webinar to have the answers to these questions.

It will be an online presentation and Q&A given by Grace Fu Palma, CEO of ChinaMed Device. 

2pm – 3pm EST, December 12th, 2018

Register Now

In Spring 2018, China’s State Council unveiled a plan to reshuffle government ministries. Along with the reshuffling plan, the China Food and Drug Administration (CFDA) has now changed its name to the National Medical Product Administration (NMPA). The name change is just the tip of iceberg. The NMPA (CFDA) changes will offer both opportunities and challenges to many foreign companies targeting the Chinese market. ChinaMed is offering the online webinar to update you in the following areas:

•             Difference between USFDA and NMPA (CFDA)
•             Major NMPA (CFDA) Updates in 2018 (Hainan policy, new classification rules, legal agent, registration holder system, overseas clinical data etc.)
•             NMPA Registration Updates in the new era
•             NMPA Clinical Updates in the new era
•             Post-Market Compliance Updates in the new era

 

Also, email us at info@ChinaMedDevice.com to receive our 2018 NMPA (CFDA) Almanac (soon to be published in January).  It is a publication of the complete major 2018 NMPA (CFDA) listing of regulation, guidelines, technical standards, adverse events, etc.

 

About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification. We are a NMPA (CFDA) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.