The process of FDA certification is very simple, looking for domestic qualified agency can, according to their requirements to provide relevant information as well as product drawings and descriptions, the rest will be handed over to them to deal with. The following medical devices as an example:
Medical device FDA certification includes: manufacturers in the FDA registration, product FDA registration, product listing registration (510 form registration), product listing audit approval (PMA audit)? Labeling and technical modification of healthcare devices, customs clearance, registration, pre-market reports.
1, the following materials must be submitted:
1) five copies of the finished product with complete packaging;
2) the device construction diagram and its text description;
3) the performance of the device and the principle of operation;
4) the device's safety demonstration or test materials;
5 )Brief introduction of the manufacturing process;
6) Summary of clinical trials;
7) Product specifications (if the device has radioactive energy or releases radioactive material, it must be described in detail).
2, start to prepare the information to the FDA declaration to be approved and recognized:
For any product, companies need to carry out the FDA business registration (Registration) and product listing (Listing).
For Class I products (about 47%), there are general controls. The vast majority of products only need to register, listing and implementation of GMP specifications, the product can enter the U.S. market (very few products are even exempt from GMP).
On Class II products (about 46%), the implementation of special controls. After registration and listing, companies are also required to implement GMP and submit a 510(K) application (very few products are exempt from 510(K)).
For Class III products (about 7%), pre-market licensing is implemented. After registration and listing, companies are required to implement GMP and submit a PMA (Premarket Application) to the FDA.