NMPA issued 28 draft guidelines on October 18 for feedback. The guidelines cover one class III device, 27 class II devices and IVDs (cardiovascular, gastroenterological, urological, dental, gynecological and pediatric products), and manufacturing methods. Feedbacks need to be submitted by November 17.
If your device involves the following guidelines, please contact us so we can translate the guideline(s) for you. info@ChinaMedDevice.com.
Whether you are renewing or submitting new registration, your medical devices and guidelines need to meet these new guidelines. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new guidelines. As a result, your originally approved products will still need to go through local type testing to show that you are current with the new guidelines. ChinaMed Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time. info@ChinaMedDevice.com.
NMPA announced the “2019 Medical Device Registration Guidelines Revision Plan” on February 25, in which 86 medical devices, IVDs and manufacturing methods are included.
Revision of more than 300 industry standards for medical devices, IVDs and quality systems could be expected by the end of 2020, NMPA announced in January 2018.
For slides of “2019 NMPA Regulatory Updates” that we shared at RAPS Convergence, please email us at info@ChinaMedDevice.com.
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ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.