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

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NMPA published the “Medical Device Submission Document Administrative Measures during the Supplement Phase” (final) on January 16, 2020. NMPA issued the draft version on November 11, 2019 for public opinion.

Commonly known as “deficiency” by U.S. FDA, Supplement Phase provides NMPA an opportunity to request additional information on medical device marketing applications. The supplement phase is needed if the registration documents submitted by the applicant cannot meet the relevant regulations or technical standards.

The document, significantly referring on FDA Guidance of Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provision, specifies the situations to initiate the supplement phase, 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

The Administrative Measures list five scenarios when Supplement Phase is initiated:

  1. 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;
  2. The relevant supporting documents or regulatory information are missing or do not meet the requirements;
  3. Problems occurs with the textual specification or Chinese translation of the application materials;
  4. The form, signature and special binding of the application materials are incompliant with regulations;
  5. Other information required.

Takeaways for Manufacturers

The document specifies the number of different requests by NMPA and applicants:

  1. NMPA will only request additional information in ONE TIME
  2. Applicants shall submit additional documents in full in ONE TIME in ONE YEAR after receiving NNPA’s request
  3. Applicants can request face-to-face meeting with NMPA THREE TIMES in the given ONE YEAR
  4. Before the final submission, applicants can request Pre-Assessment from NMPA for ONE TIME.

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.

China Med Device provides NMPA consultation services. Click HERE for details.

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; they can Paper-based submission is still available.

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

To keep up to date on NMPA (CFDA) changes, please opt in our monthly newsletter https://ChinaMedDevice.com/cmd-blogs/

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.

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