China medical device classification and approval process: all approvals can be completed in 45 days
Medical devices are classified into the first category, the second category and the third category according to the degree of risk from low to high.
One type: medical devices that are routinely managed to ensure their safety and effectiveness.
For example: basic surgical knives (surgical shanks and blades, skin knives, carcass knives, lancets, blades, razors, dandruff razors, pick knives, sharp knives, pedicure knives, manicure knives, Scalpel, etc.).
Category 2: Medical devices that should be controlled for their safety and effectiveness.
For example: (a) general examination equipment (6820): thermometer, sphygmomanometer; (b) physical therapy and rehabilitation equipment (6826): magnetic therapy equipment; (c) clinical laboratory analysis equipment (6840): household blood sugar Analyzers and test strips; (d) Operating room, emergency room, medical equipment and equipment (6854): Portable oxygen generator portable oxygen generator; (e) Medical hygienic materials and dressings (6864): Cotton wool, medical absorbent gauze; (f) Medical polymer materials and products (6866): condoms, condoms, etc.
Three types: implanted in the human body; used to support and sustain life; medical devices that are potentially dangerous to the human body and must be strictly controlled for their safety and effectiveness.
For example: (A), disposable sterile medical device 1, disposable sterile syringe; 2, disposable infusion set; 3, disposable blood transfusion device; 4, disposable anesthesia puncture package; Intravenous infusion needle; 6, disposable sterile needle; 7, disposable plastic blood bag; 8, disposable blood collection device; 9, disposable titration tube infusion device. (B), orthopedic implant medical device 1, surgical implant joint prosthesis; (disposable sterile medical devices, hearing aids, contact lenses and care solutions, in vitro diagnostic reagents, 6846 implant materials and artificial organs, Except 6877 intervention equipment).
The approval of a medical device is not fixed in which category, and it is determined by its safety. The State Food and Drug Administration (CFDA) has the right to change its classification, such as masks in general. The period was divided into one category, but it was classified into the second category during the SARS period.
First filing procedure for the first class of medical device products
Where a first-class medical device manufacturing enterprise is established, it shall handle the first-class medical device production and filing with the municipal-level food and drug supervision and administration department in the local district, and the food and drug supervision and administration department shall check the integrity of the submitted materials on the spot, in line with The prescribed conditions shall be filed and issued to the first type of medical device production record certificate.
List of materials required for filing a class of medical devices:
(1) A copy of the business license and organization code certificate;
(2) Submitting a copy of the filing certificate of the medical device produced by the filing enterprise;
(3) A copy of the identity certificate of the legal representative and the person in charge of the enterprise;
(4) A copy of the identity, education and professional title of the person in charge of production, quality and technology;
(5) A list of academic qualifications and professional titles of employees in production management and quality inspection positions;
(6) The certification documents of the production site, and the copy of the certificate of the facility and environment that should be submitted to the special production environment;
(7) a list of major production equipment and inspection equipment;
(8) Quality manuals and procedure documents;
(9) Process flow chart;
(10) The certificate of authorization of the manager;
(11) Other supporting documents.
Foot Spa Machine,Foot Tub Spa Pedicure,Foot Bath Massager,Bubble Foot Spa
Huaian Mimir Electric Appliance Co., LTD , https://www.mimirfootbath.com