NMPA issued the "Medical Device Submission Document Requirements during the Supplement Phase" (Draft) on November 11, 2019. Feedback need 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:
- Problems occurs with the textual specification or Chinese translation of the application materials;
- The form, signature and special binding of the application materials are incompliant with regulations;
- The relevant supporting documents are missing or do not meet the requirements;
- 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;
- Others information required.
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.
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.
For detailed requirements on supplemental submission and templates NMPA provides, please feel free to email me at gpalma@ChinaMedDevice.com.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------