The medical device record certificate is a legal qualification obtained by a medical device manufacturer after filing with the State Drug Administration. When an enterprise needs to change the ICP filing address, it needs to follow a certain process to ensure that the change process is legal and compliant. This article will introduce in detail the process of changing the address of the medical device filing certificate.
Process steps. Preparation of materials The manufacturer needs to prepare the following information:
Application for Change;
the changed business license;
Medical device production license;
Filing registration form (original filing number);
Other relevant information.
Submission of materials Manufacturers need to submit the prepared materials to the National Medical Products Administration and fill in the application as required**. Before submitting the information, the company needs to ensure that the information is true, complete and legal.
Review materials After receiving the application, the NMPA will review the application materials. After the review is passed, a new medical device record number and a changed filing address will be issued.
Change of filing address Manufacturers need to register and produce products according to the new filing address to ensure that the products comply with relevant regulatory requirements.
Review the production situation After the change of filing address, the State Drug Administration will review the production situation of the enterprise to ensure that the production process meets the requirements of relevant regulations.
Precautions Manufacturers need to pay attention to the following points when changing the address of the medical device filing certificate:
Ensure that the information is true, complete and legal;
All relevant formalities need to be completed before changing the address, such as product registration, etc.;
After the change of address, it is necessary to ensure that the product meets the relevant regulatory requirements;
In the production process, it is necessary to comply with relevant regulations to ensure product quality and safety.
The process of changing the address of the medical device filing certificate includes the steps of preparing materials, submitting materials, reviewing materials, changing the filing address and reviewing the production situation. When making changes, manufacturers need to ensure that the information is true, complete and legal, and operate in strict accordance with the requirements of relevant laws and regulations. After the change, the manufacturer needs to ensure that the product meets the relevant regulatory requirements and complies with the relevant regulations to ensure product quality and safety.