Regulatory Open Forum

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.

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.

If you want the detailed requirements on supplemental submission or supplement phase submission templates NMPA provides, please email info@ChinaMedDevice.com.

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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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