What is the first class of medical devices?

Question 1: The difference between Class I, Class II and Class III medical devices requires an authoritative understanding of the Regulations on the Supervision and Administration of Medical Devices.

Decree number. No.276, the State Council, People's Republic of China (PRC)

Article 5 The State implements classified management of medical devices.

The first category refers to medical devices that can ensure their safety and effectiveness through daily management.

The second category refers to medical devices whose safety and effectiveness should be controlled.

The third category refers to implantation into the human body; Used to support and sustain life; It is potentially dangerous to human body, and its safety and effectiveness must be strictly controlled.

The classification catalogue of medical devices shall be formulated, adjusted and published by the drug supervision and administration department of the State Council in consultation with the health administrative department of the State Council according to the classification rules of medical devices.

Question 2: What does a class of medical devices include? The first category of medical devices refers to medical devices that are fully managed through daily management. Under normal circumstances, any external medicine does not directly contact with skin or tissue, and its structure is relatively simple, its function is relatively simple, and it is generally passive (external or internal power supply or other power supply), which has certain auxiliary or relieving symptoms or preventive effect, and the potential risk is little or no, so it can be guaranteed that its medical devices are mostly a kind of medical devices that do not need special management; Implanted in the body, in contact with blood or body fluids, with external power supply and high power, which causes trauma or radiation damage to people and plays a major role in diagnosis, treatment or other functions, most of the three types of medical devices must be operated or managed by specialized or trained personnel to ensure their safety and effectiveness, with great potential risks; The rest are basically second-class medical devices. The number of secondary instruments accounts for 60%, and the number of primary and tertiary instruments accounts for about 20% respectively. Judging from the above principles, it is close to ten. For specific product classification, please refer to the medical device classification catalogue on the website of the US Food and Drug Administration.

Question 3: What are the advantages of a class of medical devices? The first category of medical devices refers to medical devices that can ensure their safety and effectiveness through daily management.

In the classification catalogue of medical devices, there are the following categories of products in one category 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

The following products are all one kind of medical instruments: stethoscope, percussion hammer, reflector, vision diagnostic instrument, oral knife, chisel, oral forceps, corneal scissors, ophthalmic surgical scissors, micro-scissors, micro-gun-shaped surgical scissors, micro-tissue scissors, photo rack, sky rail rack, X-ray photo box, film developing rack and X-ray darkroom equipment.

Question 4: Which medical devices belong to the first category of household medical devices? In the classification of medical devices, most medical devices belong to the first category. The country is relatively loose in management and the application procedures are relatively simple, so it gives people the impression of ordinary equipment, but because it is also an auxiliary means of medical treatment, it is defined as medical equipment. For example, many of the following are:

Family health care equipment pain equipment, family health care self-checking equipment, sphygmomanometer, electronic thermometer, multifunctional therapeutic instrument, blood glucose meter, vision improvement equipment, sleep improvement equipment, oral hygiene products, adult family health care equipment.

Electric chair/bed for household health products; *** ; * * * sigh; * * * pillows; * * * cushion; * * * belt; qi and blood

Circulating machine; Foot bath tub; Plantar organs; Hand-held * * * device, * * * bathtub, fat belt;

Therapeutic instruments; Foot physiotherapy instrument; Weight loss belt; Car seat cushion; Kneading pad; * * * Chairman; Breast augmentation device;

Beauty equipment.

Family medical rehabilitation equipment, therapeutic instrument, Kang Kai high potential therapeutic instrument, cervical vertebra therapeutic instrument, domestic cervical vertebra and lumbar vertebra tractor, traction chair, physiotherapy instrument, sleeping instrument, functional chair, functional bed, supporter and medical inflatable air cushion; Oxygen generator, decocting device, hearing aid, etc.

Home care equipment, home rehabilitation care auxiliary equipment, women's pregnancy and baby care products, home support gas transmission equipment; Oxygen cylinder, oxygen bag, family first aid medicine box

Question 5: What are the first-class medical devices? 0 1. Description of medical equipment catalogue 02+38+0 Basic surgical equipment.

03.6802 Microsurgical instruments

04.6803 neurosurgical instruments

05.6804 Ophthalmic surgical instruments

06.6805 Otolaryngology surgical instruments

07.6806 Dental surgical instruments

08.6807 thoracic cardiovascular surgical instruments

09.6808 Abdominal surgical instruments

10.6809 surgical instruments for uroanorectal surgery

1 1. 10 orthopedic surgical instruments

12.6438+02 Obstetrics and Gynecology Surgical Instruments

13.438+03 family planning surgical instruments

14.6438+05 injection puncture instrument

15.6438+06 surgical instruments for burns (plastic surgery)

16.6820 universal diagnostic instrument

17.6338+0 medical electronic instruments and equipment

18.6822 medical optical instruments, instruments and endoscopic equipment

19.6823 medical ultrasonic instruments and related equipment

20.6824 Medical laser instruments and equipment

2 1.6825 medical high-frequency instruments and equipment

22.6826 Physical therapy and rehabilitation equipment

23.6827 Chinese medicine equipment

24.6828 medical magnetic vibration equipment

25.6830 medical x-ray equipment

26.6438+0 medical x-ray accessory equipment and components.

27.6832 medical high-energy ray equipment

28.6833 medical radionuclide equipment

29.6834 Medical radiation protection articles and devices

30.6840 Clinical inspection and analysis instruments

3 1.645438+0 medical laboratory and basic equipment and appliances

32.6845 Extracorporeal circulation and blood treatment equipment

33.6846 Implants and artificial organs

34.6854 Operating room, emergency room and clinic equipment and appliances.

35.6855 Oral equipment and appliances

36.6856 Ward nursing equipment and appliances

37.6857 Disinfection and sterilization equipment and appliances

38.6858 Medical cold therapy, cryogenic and refrigeration equipment and appliances.

39.6863 dental materials

40.6864 Medical sanitary materials and dressings

4 1.6865 medical suture materials and adhesives

42.6866 medical polymer materials and products

43.6870 software

44.6877 Interventional equipment

Question 6: What is the difference between the first type of medical devices and the second type of medical devices? According to the requirements of the State Administration of Medical Products, medical devices are divided into three categories, and the requirements for products are higher according to categories, among which three categories are the highest. According to the category, the products they operate are mainly different, such as the first category is large and medium-sized medical devices for external use, and the second category is implantable devices, such as esophageal stents and other similar products.

Question 7: What is a national first-class medical device? According to Article 4 of the Regulations on the Supervision and Administration of Medical Devices, the state implements classified management of medical devices according to the degree of risk.

The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.

The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.

The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.

To evaluate the risk degree of medical devices, the expected use, structural characteristics and use methods of medical devices should be considered.

The State Council The US Food and Drug Administration is responsible for formulating the classification rules and catalogues of medical devices, timely analyzing and evaluating the risk changes of medical devices according to their production, operation and use, and adjusting the catalogues. To formulate and adjust the classification catalogue, we should fully listen to the opinions of medical device manufacturers, users and industry organizations, and refer to international medical device classification practices. The classified catalogue of medical devices shall be announced to the public.

Question 8: The difference between the first and second types of medical devices. Medical device products are divided into three categories: the first category refers to products that can ensure safety and effectiveness through routine management; The second category means that the product mechanism has been recognized internationally and domestically, the technology is mature, and the safety and effectiveness must be controllable; The third category refers to being implanted into the human body, or being used for life support, or the technical structure is complex, which may have potential dangers and safety hazards to the human body.

Question 9: What is the registration process of a class of medical devices? Procedures for Registration and Approval of Class I Medical Devices in China

The first class medical device registration (re-registration) in China consists of acceptance and administrative examination and approval. The total time limit for examination and approval is within 30 working days from the date of issuing the acceptance notice.

I. Acceptance

Mainly review the application materials for registration (re-registration) of Class I medical devices in China, ensure the integrity and standardization of the application materials, and announce the acceptance to the public.

Medical device manufacturers applying for registration (re-registration) of Class I medical devices in China shall submit the required registration application materials to the local food and drug supervision and administration department.

(1) Acceptance requirements

1. Application Form for Registration of Domestic Medical Devices

The Application Form for Registration of Domestic Medical Devices filled in by the applicant enterprise shall be signed by the legal representative and stamped with the official seal. The items filled in shall be complete and accurate, and the contents filled in shall meet the following requirements:

(1) The name and registered address of the production enterprise are the same as the industrial and commercial business license;

(2) "Product name" and "specifications and models" are consistent with the names, specifications and models used in the application materials such as product standards and test reports submitted.

2. Qualification certificate of medical device manufacturing enterprise

The qualification certificate includes a copy of the Registration Form of Class I Medical Device Manufacturers and a copy of the Industrial and Commercial Business License.

(1) The products applied for registration (re-registration) shall be within the production range approved by the Registration Form of Class I Medical Device Manufacturers;

(2) The industrial and commercial business license is within the validity period.

3. Applicable product standards and descriptions

The product standards submitted by the applicant enterprise can be national standards, industry standards or registered product standards.

(1) Where a national standard or an industry standard is adopted as a product standard, an effective text of the adopted national standard or industry standard and an explanation of the adoption shall be submitted;

(2) If the registered product standard is adopted as the product standard, the official text of the registered product standard and its compilation instructions shall be submitted.

4. Product full performance test report

The product full performance test report shall include the following contents:

(1) product name, specification, product number or batch number, production date, sample number and sampling base;

(2) Test basis, test items, standard requirements, test results, result judgment, signatures or seals of inspectors and auditors, test date, etc. ;

(3) If the inspection is entrusted, the inspection report and the entrusted inspection agreement issued by the entrusted inspection institution shall be provided.

5. Description of the existing resource conditions and quality management capabilities (including testing methods) of the products produced by the enterprise.

The description of the existing resource conditions and quality management capabilities (including testing methods) of enterprise products shall include the following contents:

(1) Description of existing resources (human resources, infrastructure, working environment, etc. ), the management ability, production capacity, inspection means and ability of the applicant enterprise;

(2) Provide a list of valid verification certificates (copies) of production equipment, testing instruments and measuring instruments required for product inspection.

6. Instructions for medical devices

Instructions for medical devices shall at least include the following contents:

(1) product name, model and specification;

(2) The name, registered address, production address and contact information of the production enterprise;

(3) The license number, medical device registration certificate number (blank at the time of declaration) and serial number of the medical device manufacturer. Product standards;

(4) Performance, main structure and application scope of the product.

7. Product quality tracking report (chickens are used for re-registration)

The product quality tracking report shall include the following contents:

(1) Description of enterprise product quality control measures and internal audit product quality review;

(2) Feedback from users on product quality during product use;

(3) Regular inspection and daily ex-factory inspection of product quality; Product quality supervision and sampling inspection by the (food) drug supervision and administration department at or above the provincial level;

(4) The enterprise implements the adverse event monitoring system and adverse event monitoring;

(5) Product quality information, statistical analysis, measures taken and verification collected by the enterprise.

8. Original medical device registration certificate (applicable to re-registration)

(1) In case of Article 33 in Chapter 5 of the Measures for the Administration of Medical Device Registration, a copy of the original medical device registration certificate shall be submitted;

(2) In case of Article 34 and Article 35 of Chapter 5 of the Administrative Measures for the Registration of Medical Devices, the original medical device registration certificate shall be submitted.

......& gt& gt

Question 10: It is best to have an authoritative understanding of the Regulations on the Supervision and Administration of Medical Devices regarding the differences between the first, second and third types of medical devices.

Decree number. No.276, the State Council, People's Republic of China (PRC)

Article 5 The State implements classified management of medical devices.

The first category refers to medical devices that can ensure their safety and effectiveness through daily management.

The second category refers to medical devices whose safety and effectiveness should be controlled.

The third category refers to implantation into the human body; Used to support and sustain life; It is potentially dangerous to human body, and its safety and effectiveness must be strictly controlled.

The classification catalogue of medical devices shall be formulated, adjusted and published by the drug supervision and administration department of the State Council in consultation with the health administrative department of the State Council according to the classification rules of medical devices.