Registration Certificate Management for Medical Devices

      The validity period of the medical device registration certificate is stipulated according to the classification of medical device products. According to the regulations on medical device supervision and regulation, the validity period of the medical device registration certificate is as follows:

  • The registration certificate for Class II and III medical devices is valid for 5 years.
  • There is no validity period for the registration and filing certificate of Class Ⅰ

      During this validity period, medical device companies can produce and sell medical devices in accordance with the provisions of the registration certificate. However, after the medical device registration certificate expires, it needs to be updated or reapplied in time.

      In actual production and sales, medical device companies must continuously conduct quality monitoring during the validity period of the registration certificate to ensure that the quality of the products meets the requirements of national regulations. At the same time, before the validity period is about to expire, medical device companies also need to prepare application materials for registration certificate renewal in advance and conduct renew in a timely manner.

      In addition to the validity period specified above, the medical device registration certificate having the following circumstances needs re-application.

When the following circumstances occur, the medical device registration certificate needs to be re-applied:

  • The product has undergone major changes: If the medical device product has undergone major technical changes, material composition changes, etc., it is necessary to re-apply for the registration certificate.
  • Change of product classification: If the classification of a medical device product changes, it is necessary to re-apply for the registration certificate.
  • Product transfer: If a medical device product is transferred to other companies or individuals, it is necessary to re-apply for the registration certificate.

When renewing the registration of medical devices, the following problems need to be avoided:

  • The enterprise fails to submit an application for renewal of registration at the time of 6 months before the expiration of the validity period;
  • The product management category has been adjusted, and the enterprise has not reported to the relevant departments according to the new management category;
  • The enterprise failed to submit a complete medical device registration certificate and change approval documents, and did not provide supporting documents for raw materials with registration certificates or other medical devices used with it
  • The enterprise’s production address has changed, but it didn’t apply registration item change in advance;
  • In the product analysis report within the validity period, the company did not explain the clinical application of the product; whether there were any user complaints and the measures taken; and did not provide a list of suspected adverse events in the years after its launch;
  • When renewing registration, the company is required to provide color photos of the product in order to understand the product more intuitively and judge whether it has changed and whether it is consistent with the description in the application materials;
  • The original instructions for some products do not specify the validity period. For the validity period claimed in the instructions at the time of renewal registration, corresponding verification reports and other supporting information should be provided.
  • Use vague expressions such as “mainly” and “etc.” in product structure composition or model specifications.

      For medical device products, in order to maintain the validity of the registration certificate, companies should actively fulfill the relevant requirements of the regulatory authorities to ensure product quality and compliance. At the same time, enterprises should also pay attention to the validity period of the registration certificate and apply for renewal in a timely manner to avoid unnecessary losses due to expiration.

Q&A About Registration Certificate Management

  • After the medical device registration certificate change document is approved and issued, if there is a surplus of packaging materials from the previous version, can it continue to be used? Is there a grace period for use?

According to the requirements of the “Regulations on the Supervision and Administration of Medical Devices”, medical devices should have instructions and labels. The content of instructions and labels should be consistent with the relevant registered or filed content to ensure authenticity and accuracy. Besides, the relevant information in the instructions and labels of your company’s medical device products should be consistent with the relevant information in the valid product registration certificate.