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Submission Material Signature and Registration Certificate Going Paperless

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risk assessment questions and china medical devices

Electronic signature, certificate and documents have gained popularity due to higher efficiency and availability overseas.

Submission Material Electronic Signature

NMPA issued a release called “Matters Related to the Trial Implementation of Electronic Signatures for Imported Medical Device Registration Application Materials” on September 29. It allows the usage of submission material electrical signature during volume review and technical review; Paper-based signature is still recognized.

Along with “CH1.11.5 Statement of Authenticity and Accuracy”, applicants shall submit the following items:

  1. Explanation on the use of electronic signature
  2. Foreign legal system certification documents for electronic signature, with Chinese translation
  3. Explanation on how to obtain the electronic signature
    list of responsible persons and signature sample, and quality system documents as needed
  4. Statement of Authenticity

Registration Certificate

NMPA published “Pilot Use of the Electronic Registration Certificate for Medical Devices”, trialing the electronic registration certificate from October 19, 2020 to August 31, 2021. The document announced that:

  1. It is applicable for initial registration certificates for domestic Class III, imported Class II, and Class III medical device,
  2. Both versions, paper-based and electronic certificates, will be issued in the pilot period,
  3. The electronic certificate does not contain the technical requirements of the product,
  4. Applicants shall first register on the NMPA administration page.

China Med Device, LLC

Feel free to contact us with any further questions about electronic signatures and certificates.

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