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On October 16, the State Drug Administration issued a notice on the pilot implementation of electronic medical device registration certificate, from October 19, 2020 to August 31, 2021, the pilot launch of electronic medical device registration certificate, the pilot scope of issuance from the date of the announcement newly approved domestic third category, import second and third category of first-time registration of medical device registration certificate.
the following is the original announcement: The State Drug Administration's announcement on the pilot implementation of electronic registration certificates for medical devices (No. 117 of 2020) in order to implement the State Council on deepening the reform of "discharge" services, optimize the business environment, promote the "Internet and government services" work of important decision-making deployment, to provide enterprises with more efficient and convenient government services, after research decision, from October 19, 2020, the pilot implementation of electronic medical device registration certificate.
will now announce the relevant matters as follows: First, the pilot period is from 19 October 2020 to 31 August 2021.
II. The scope of pilot issuance shall be the first-time registration certificates for domestic-made category III, import second and third categories of domestically approved medical devices from the date of the announcement, and the registration changes and renewal registrations shall be gradually issued as the case may be.
, during the pilot period, the electronic registration certificate for medical devices and the registration certificate for paper medical devices were issued simultaneously.
electronic medical device registration certificate has the same legal effect as the paper medical device registration certificate.
, medical device electronic registration certificate does not contain the technical requirements of this product.
, enterprises must first register in the State Drug Administration online office hall and real-name certification, before entering the online office hall "my license" column, view the download of medical device electronic registration certificate.
can also log on to the "China Drug Administration APP" to view the electronic registration certificate of medical devices.
this announcement.
, October 16, 2020