Individual businessmen are not allowed to apply for Class II medical devices for the record.
The Food and Drug Administration stipulates that the main body of the application for the filing of medical devices or licenses must be an enterprise, and individual business households are not accepted.
If you want to operate Class II medical devices, your (individual) business license can be upgraded to the Business and Industry Bureau for business. Directly to the Industrial and Commercial Bureau tube piece of the industrial and commercial office registration, fill out the form, and then take the relevant materials to the government hall for business license upgrade, upgrade to enterprise, and then to the online declaration can be.
Expanded Information:
On the application and acceptance of Class II medical devices:
Applicants log on to the Beijing Municipal Drug Administration enterprise service platform for online reporting, according to the scope of the acceptance of the provisions of the application materials need to be submitted as follows:
(a) "the Chinese People's Republic of China * * * and the State of the medical device registration Application Form";
Applicant companies to fill in the "Chinese People's **** and the State Medical Device Registration Application Form" should be signed by the legal representative and stamped with the official seal, the items filled in should be complete and accurate, fill in the content should meet the following requirements:
1, "Manufacturer's Name", "Registered address" is the same as the "Medical Device Manufacturer License".
2, "product name", "model, specification" and the submitted product standards, test reports and other application materials used in the name, model, specifications consistent.
(2) "Medical Device Registration Form";
1, "Manufacturer Name", "Enterprise Registered Address", "Production Address" and the Medical Device Manufacturer License" content is the same.
2, "product name", "model, specification" must be consistent with the product standards.
3, "product standards" should fill in the current valid product standard number and name.
(C) medical device manufacturer qualifications (including "medical device manufacturer license" copy and "business license" copy)
1, the application for registration of the product should be in the "Medical Device Manufacturer License" approved within the scope of production.
2, "Medical Device Manufacturer's License" and "Industrial and Commercial Business License" should be within the validity period.
(D) product standards (can be national standards, industry standards or registered product standards) and related notes
1, directly adopting national standards, industry standards as product standards, should be submitted to the national standards or industry standards adopted by the validity of the text and the adoption of the standard description.
The adoption of the standard should include at least the division of product specifications, product management category, the product's factory testing program, the full implementation of this standard commitment and other content should be explained.
2, registered product standards should be submitted in the validity of the official text, preparation instructions and review materials. Review materials include "Beijing medical device product standard review form", "Beijing medical device product standard review opinion form", "Beijing medical device product standard review personnel list".
(E) product instructions
Medical device instructions should be consistent with the "medical device instructions, labels and packaging marking regulations" of the corresponding provisions, at least should include the following:
1, product name, model number, specifications.
2, the name of the manufacturer, registered address, production address, contact information.
3, "Medical Device Manufacturer License" number, medical device registration certificate number (declaration of the content of this item is blank), the product standard number;
4, the performance of the product, the main structure, scope of application.
(F) registered product photos
Declaring enterprises should be registered according to the different specifications of the product, model to provide more than 5-inch (including 5-inch) color photos. The photo should clearly reflect the full picture of the product.
(VII) registration diskette
1, should include the registration application form, registration form, instructions and registered product standards.
2, the contents of the diskette should be consistent with the application materials.
3, the diskette should indicate the name of the applicant company and the name and model of the product application.
Baidu Encyclopedia - Class II Medical Devices