(1) Medical device filing means that the food and drug supervision and administration department files the filing materials of Class I medical devices submitted by medical device filers (hereinafter referred to as filers) for future reference.

(2) The medical devices for filing are Class I medical devices in the Catalogue of Class I Medical Devices and the corresponding in-vitro diagnostic reagent classification subdirectories.

For the filing of Class I medical devices in China, the filing person shall submit the filing materials to the municipal food and drug supervision and administration department with districts. For the record-keeping of imported medical devices of Class I, the record-keeping person shall submit the record-keeping materials to China Food and Drug Administration. The filing of medical devices in Hongkong, Macau and Taiwan Province shall be handled with reference to imported medical devices.

(3) The registered imported medical devices shall obtain the marketing permission of medical devices in the country (region) where the registrant is registered or the place where the production address is located.

If the product is not managed as a medical device in the country (region) where the registrant is registered or the country (region) where the production address is located, the registrant shall provide relevant certification documents, including certification documents that the country (region) where the registrant is registered or the country (region) where the production address is located allows the product to be legally listed.

(4) Overseas filers shall handle the filing of imported medical devices through their representative offices established in China or designated domestic legal person enterprises as agents.

(five) the filing person shall prepare the product technical requirements for the medical devices to be filed. The technical requirements of products mainly include the performance indexes and inspection methods of finished medical devices.

(6) When filing medical devices, the filer shall submit the filing materials according to the relevant requirements (see Annex 1) and be responsible for the authenticity, completeness and compliance of the filing materials.

(seven) if the filing materials meet the requirements, the food and drug supervision and administration department shall release them on the spot. If the filing materials are incomplete or do not conform to the prescribed form, it shall inform all the contents that need to be corrected at one time. If it is not filed, it shall inform the filer and explain the reasons.

(eight) for medical devices that need to be put on record, the food and drug supervision and administration department shall, in accordance with the relevant requirements, make a record certificate and publish the information published in the record information table on its website.

The food and drug supervision and administration department shall carry out the filing work in accordance with the first class medical device filing operation standard. The filer shall mark the record number on the instructions and labels of medical devices.

(9) If the contents published in the filing information form and the technical requirements of the medical devices that have been filed change, the filer shall submit the explanation of the change and relevant supporting documents, and submit the information of the change to the original filing department.

If the food and drug supervision and administration department meets the formal requirements for the filing materials, it shall indicate the changes in the change column and file the filing materials.

(ten) the arrangement of the record numbers of the first class medical devices is:

× 1 mechanical equipment××××××× 2××××× 3.

These include:

X1is the abbreviation of the place where the filing department is located:

The first category of imported medical devices is the word "country";

The first category of medical devices in China is the abbreviation of the province, autonomous region and municipality directly under the central government where the filing department is located plus the abbreviation of the municipal administrative region (there is no corresponding municipal administrative region with districts, but only the abbreviation of the province, autonomous region and municipality directly under the central government);

××××2 is the year of filing;

×××××× 3 is the serial number for filing.

Implementation time

Regulations on the Supervision and Administration of Medical Devices (Order No.650th of the State Council) came into force on June 0, 2004. According to the regulations, the first category of medical devices shall be subject to product filing management.

Extended data

Classification catalogue of medical devices

Basic surgical instruments Microsurgical instruments

Neurosurgical instruments, ophthalmic surgical instruments

Otolaryngology surgical instruments stomatology surgical instruments

Thoracic cardiovascular surgical instruments, abdominal surgical instruments

Surgical instruments for urology, anorectal surgery and orthopedic surgery (plastic surgery)

Obstetrics and gynecology surgical instruments, family planning surgical instruments

Injection puncture instrument burn (plastic) surgical instrument

General diagnostic instruments, medical electronic instruments and equipment

Medical optical instruments, instruments and endoscopic equipment medical ultrasonic instruments and related equipment

Medical laser instruments and equipment medical high-frequency instruments and equipment

Physical therapy rehabilitation equipment traditional Chinese medicine equipment

Medical magnetic vibration equipment medical x-ray equipment

Medical x-ray accessory equipment and components medical high-energy x-ray equipment

Medical radionuclide equipment, medical radiation protection articles and devices

Clinical laboratory analytical instruments, medical laboratory tests and basic equipment and appliances

Extracorporeal circulation and blood treatment equipment, implant materials and artificial organs

Equipment and appliances for operating rooms, emergency rooms and clinics; Dental equipment and appliances.

Ward nursing equipment and appliances disinfection and sterilization equipment and appliances

Medical cold therapy, cryogenic and refrigeration equipment and appliances dental materials

Medical sanitary materials and dressings, medical suture materials and adhesives

Interventional equipment for medical polymer materials and products

Baidu Encyclopedia-A Medical Device