Drugdu.com expert's response:

The continuation registration of medical devices should generally be applied for with the original registration authority six months before the expiration of the medical device registration certificate. Here is a detailed explanation:

I. Legal Basis

Regulations on the Supervision and Administration of Medical Devices: It explicitly stipulates that the validity period of a medical device registration certificate is five years. If continuation registration is required upon expiration, an application for continuation registration should be submitted to the original registration authority six months before the expiration date.

Measures for the Registration and Filing of Medical Devices: It further refines the application process and requirements for continuation registration, emphasizing that enterprises need to submit applications within the specified time to ensure the validity of the registration certificate.

II. Application Time Requirements

Apply six months in advance: Enterprises should submit an application for continuation registration to the original registration authority six months before the expiration date of the medical device registration certificate. For example, if the registration certificate expires on December 31, 2025, the application for continuation registration should be submitted before June 30, 2025.

Handling of special circumstances: If, due to special reasons (such as force majeure), an enterprise cannot apply in advance, it may apply for an extension with the relevant department, but the extension period generally should not exceed three months.

III. Application Process and Precautions

Prepare application materials: Enterprises should prepare all the necessary materials for continuation registration in advance, including but not limited to product technical requirements, quality management system documents, and clinical evaluation materials.

Submit the application: Within the specified time, submit the application for continuation registration to the original registration authority through online or offline methods and obtain an acceptance notice or a correction notice issued upon review.

Follow up on the approval progress: Enterprises should closely monitor the approval progress and promptly respond to the requirements of the regulatory authority, such as providing supplementary materials or participating in review meetings.

Complete the registration update: After approval, enterprises should promptly complete the update of the registration certificate to ensure that the product can continue to be legally produced and sold.

IV. Consequences of Late Application

Invalid registration certificate: If an enterprise fails to submit an application for continuation registration within the specified time or the application is not approved, its medical device registration certificate will become invalid.

Inability to circulate products: After the registration certificate becomes invalid, the enterprise will no longer be able to continue producing and selling the medical device product, which will have a serious impact on its business development and market competitiveness.