NMPA New Guideline on How to Address “Submission Deficiency” in China

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November 13, 2019
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NMPA New Guideline on How to Address “Submission Deficiency” in China

NMPA issued the “Medical Device Submission Document Requirements during the Supplement Phase” (Draft) on November 11, 2019. Feedback needs to be summited by November 30, 2019.

The document specifies the situations to initiate the supplement phase (commonly known as “deficiency” by U.S. FDA), suggested content and format for notification letters by NMPA, and suggested format for response letters and submission materials by manufacturers.

When to Submit Additional Documents

Supplement Phase is intended to help NMPA reviewers develop a request for additional information needed to make a decision on a medical device marketing application. The supplement phase is initiated if the registration documents submitted by the applicant cannot meet the relevant regulations or technical standards. Situations include:

  1. Problems with the textual specification or Chinese translation of the application materials;
  2. The form, signature and special binding of the application materials are incompliant with regulations;
  3. The relevant supporting documents are missing or do not meet the requirements;
  4. Technical information on safety and effectiveness evaluation (e.g. physical and chemical properties, electrical safety, biological evaluation, clinical evaluation, etc.) are inadequate, incomplete or incorrect;
  5. Other required information is missing.

Implication with ePRS

As the NMPA electronic Regulated Product Submission (eRPS) system has been implemented on June 24, 2019, applicants can review notification letters and submit response letters and submission documents online. Paper-based submission is still available.

For detailed requirements on supplemental submission and templates NMPA provides, please email info@ChinaMedDevice.com.

NMPA published the “Notice of Medical Device Pre-Assessment during Supplement Phase” on September 12, 2018, enabling manufacturers to communicate with NMPA reviewers before supplement submission and know in advance if they meet the supplemental requirements.

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About China Med Device, LLC 

China Med 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.