The Medical Devices equipment industry classification level is relatively clear. In the process of registration and certification of enterprises, except for the first type of medical devices that do not need to be registered, the second and third types of medical devices are required. For the second-class medical device registration, what materials need to be submitted by the company in the registration process, and what is the specific process? I will share with you the content in this regard.
Qualification requirements for applying for Class II medical devices:
1. Legal person and shareholder information
2. Company name
3. Provide address information
4. Product business catalog and certificate of conformity
5. The graduation certificates and relevant resumes of the three personnel
Application process for Class II medical device qualification:
1. The applicant submits the application materials to the relevant department;
2. Relevant departments accept the applicant's application;
3. Go to the actual site to conduct surveys and review the products;
4. Approve the issuance of Class II medical device licenses;
5. Issuing the second-class medical device license.
Children mattress Manufacturer registration will be stricter in terms of review. During the registration process, companies must understand the process and conditions. This is related to whether the registration can be successful. In addition, the latest relevant policies on the medical industry also need to be roughly understood, so that it will be helpful to the company's business in the follow-up process.