Expert Panel Guideline in China MedTech Issued

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Expert Panel Guideline in China MedTech Issued

NMPA published the “Guideline on Expert Panel/ Public Advisory Meeting” on December 5, 2019. During the NMPA registration process, Expert Panel weigh the available evidence and provide scientific and medical advice on the safety and efficacy of products that NMPA regulates. NMPA weighs the advice that it receives when taking final actions.

The guideline is to “standardize the expert consulting procedure, utilize external expertise outside of government, and ensure the quality of technical review work,” NMPA stated in the notice.

Five Scenarios for Expert Panel

The Expert Panel is made available when applicants apply:

  1. Innovation Device
  2. Priority Review
  3. Emergency Approval
  4. Approval without predicate device on market
  5. Clinical Trial Approval

China Med Device has helped clients set up NMPA expert panels for their innovative devices and the devices without predicate in China. We also have extensive hospital and KOL resources, able to hold expert communication sessions to collect their opinions on your devices. If you need experts’ opinions on your device, please email info@ChinaMedDevice.com.

Content of Request

After manufacturers’ proposal, the primary reviewer from the Review Department or the newly-established Clinical Department submits a formal request to NMPA. The request contains:

  1. Expertise of experts
  2. Number of experts
  3. Questions to be asked
  4. Experts and institutes with conflicts of interest

7 Need-to-Know for Manufacturers

Below are highlights from the guideline:

  1. Preferred experts can be named by the primary reviewer.
  2. NMPA will determine the time and meeting location in 30 days for domestic applicants and 40 days for overseas applicants.
  3. Meetings will be announced at least 15 days in advance.
  4. Meetings will be held in public.
  5. Encourages patients, healthcare providers and other interested people to share their views during the open public hearing.
  6. If disagreement arises, a 2/3 majority opinion of experts will be followed
  7. Six annexes are provided for experts’ expertise, Expert Committee Code of Conduct, Meeting Procedure, Advisory Report, etc.

For English version of the “Guideline on Expert Panel/Public Advisory Meeting” and other official NMPA documents, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

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About ChinaMed Device, LLC 

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.