The US Food and Drug Administration stipulates that applicants for medical device filing or licensing must be enterprises, and individual industrial and commercial households will not accept them.
If you want to operate Class II medical devices, your (individual) business license can be upgraded at the Industrial and Commercial Bureau. Go directly to the industrial and commercial office in charge of the industrial and commercial bureau to register and fill in the form, then take the relevant materials to the government affairs hall to upgrade the business license to an enterprise, and then declare online.
Extended data:
Application and acceptance of Class II medical devices;
An applicant who logs on to the enterprise service platform of Beijing Drug Administration for online declaration shall submit the following application materials according to the provisions of the scope of acceptance:
(1) Application Form for Registration of Medical Devices in People's Republic of China (PRC);
The "Application Form for Registration of Medical Devices in People's Republic of China (PRC)" filled out by the applicant enterprise shall be signed by the legal representative and stamped with the official seal. The items to be filled in shall be complete and accurate, and the contents to be filled in shall meet the following requirements:
1, and the name and registered address of the manufacturing enterprise are the same as those of the Medical Device Manufacturing Enterprise License.
2 "Product name" and "model specification" are consistent with the names, models and specifications used in the application materials such as product standards and test reports submitted.
(2) An application form for registration of medical devices;
1, the name, registered address and production address of the manufacturing enterprise are the same as those in the Medical Device Manufacturing Enterprise License.
2. "Product name", "model and specification" must be consistent with product standards.
3, "product standard" should fill in the current effective product standard number and name.
(three) the qualification certificate of the medical device manufacturing enterprise (including a copy of the license of the medical device manufacturing enterprise and a copy of the industrial and commercial business license)
1. The products applied for registration shall be within the production range approved by the Medical Device Manufacturing Enterprise License.
2, "medical device manufacturing enterprise license" and "business license" should be within the validity period.
(four) product standards (which can be national standards, industry standards or registered product standards) and related descriptions.
1. If the national standard or industry standard is directly adopted as the product standard, the valid text of the adopted national standard or industry standard and the explanation of the adoption shall be submitted.
The description of adopting the standard should at least include the division of product specifications and models, product management categories, ex-factory inspection items of products, commitment to fully implement this standard and other contents that should be explained.
2, registered product standards should be submitted within the validity period of the official text, preparation instructions and review materials. The examination materials include the examination form of Beijing medical device product enterprise standard, the examination opinion form of Beijing medical device product enterprise standard and the list of Beijing medical device product enterprise standard examiners.
(5) Product instruction manual
Instructions for medical devices shall conform to the corresponding provisions of the Regulations on the Administration of Instructions, Labels and Packaging Labels of Medical Devices, and at least include the following contents:
1, product name, model and specification.
2. Name, registered address, production address and contact information of the production enterprise.
3, "medical device manufacturing enterprise license" number, medical device registration certificate number (blank at the time of declaration), product standard number;
4. Product performance, main structure and scope of application.
(6) Registered product photos
The reporting enterprise shall provide color photos of more than 5 inches (including 5 inches) according to different specifications and models of registered products. Photos should clearly reflect the whole picture of the product.
(7) Registration floppy disk
1, which shall include the registration application form, registration form, instructions and registered product standards, etc.
2, the contents of the floppy disk should be consistent with the application materials.
3, floppy disk should indicate the name of the applicant and product name and model.
Baidu Encyclopedia-Class II Medical Equipment