Electronic signature, certificate and documents have gained popularity due to higher efficiency and availability overseas.
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:
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:
Feel free to contact us with any further questions about electronic signatures and certificates.