510(k) is the premarket submission to FDA demonstrating that the device is marketed as at least safe and effective, that is, substantially equivalent, to a legally marketed device (21?CFR?807.92(i)(3)). Submitters must compare one or more similar legally marketed devices to make their device and support their substantial equivalence.
Medical Device FDA 510(K)?Exempt Registration:
This consists of two parts: company registration and product listing. After the registration is completed, enter the appropriate registration code, search code, or company name can go to the FDA official website to find the relevant information. The cost includes two aspects.
One is the FDA annual fee charged by the U.S., which is paid in the form of U.S. dollars directly to the FDA's coffers, and is renewed on October 1-December 31 each year to maintain the validity of the FDA's registrations, and the amount of the fee varies from year to year. The other is the agent fee charged (is included in the company registration, product registration, the U.S. agent).
Panama began using the Medical Supplies Act 1966 to regulate medical supplies (including chemicals, biologicals, medical devices, herbal products, vitamins and minerals) as early as 1966.
Peru's Medical Supplies Act 1989 is currently the main act regulating medical supplies and is designed to set out how to ensure the quality of medical supplies in Australia.
Arab safety and efficacy to provide a set of national program. 2002 Australia enacted the Medical Devices Regulations 2002, which is a special regulation in the management of medical devices.
The TGA carries out product market access and market regulation responsibilities under the Therapeutic Goods Act, the Medical Devices Regulations 2002, and ensures that medical devices marketed in Australia are compliant with the standards and further develops Australia's therapeutic and medical device industries.
Extended information:
. p>Declaration materials:
(1) "Medical Device Manufacturer License" (start-up) application form;
(2) legal representative, the person in charge of the enterprise's basic information and proof of qualifications, including proof of identity, proof of academic qualifications, proof of title, a copy of the appointment documents, work resume;
(3) business administration department issued by the approval of the enterprise name Notification or business license issued by the administration for industry and commerce, the original and a copy of the original;
(4) production site documents, including property certificates or lease agreements and the leased party's property certificates a copy of the general layout of the plant, the main production workshop layout. Workshops with clean requirements, must indicate the function of the room and the direction of the flow of people;
(5) the enterprise's production, technology, quality department responsible for the resume, a copy of the certificate of qualifications and titles; relevant professional and technical personnel, skilled workers registration form, copies of certificates, and indicate the department and position; the proportion of senior, middle and junior technical personnel table; a copy of the certificate of the internal auditor;
(6) the scope of products to be produced, varieties and related product profile. The product profile includes at least a description of the product's structural composition, principles, intended use and product standards.
Baidu Encyclopedia-Medical Device Registration Certificate