NMPA Temporary Rearrangements to Facilitate Registrations Affected by COVID-19

On 15.04.2020, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) announced (No.13-2020) temporary measures to rearrange the submission time and format of notarized documents for the applications of medical device registration affected by the COVID-19 outbreak.

Submission time for notarized documents

The NMPA has acknowledged that the outbreak of Covid-19 may present challenges for timely submission of documents from overseas. Therefore, in respect of any importing class II and III medical devices that are yet to submit the applications of product registration, change in registration, registration renewal, and clinical trials, the NMPA Legal Agent may proceed to submit any documents containing the signature of the overseas applicant first, whilst explaining the difficulties of the current situation in the CH1.11.5 section “Statement of authenticity and accuracy”, and stating that the NMPA Lega Agent will bear the corresponding legal responsibility for the authenticity and validity of the document yet to be notarized.

Form of notarized document submission

If overseas applicants and NMPA Legal Agents decide to handle NMPA medical device registration affairs online, they must submit an explanatory document to address the new notarized form in the CH1.11.5 section “Statement of authenticity and accuracy”.

Notarized documents meeting the above requirements will be accepted during the review process. The time to resume normal submission of notarized documents will be notified in accordance with the epidemic situation.

By Jacky Li. Contact Cisema to learn more.