The People's Republic of China *** and the State Council Decree No. 276
Article V. The state of the medical devices to implement the classification management.
Class I refers to, through routine management is sufficient to ensure the safety and effectiveness of medical devices.
Class II refers to its safety and effectiveness of medical devices should be controlled.
Class III refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
The classification of medical devices by the State Council Drug Administration in accordance with the rules of classification of medical devices, the State Council administrative department of health to develop, adjust and publish.
Question 2: What is included in a class of medical devices Class I medical devices refers to, through the routine management of sufficient medical devices. In general, where the in vitro application is not in direct contact with the skin or tissue, the structure is relatively simple, relatively single function, generally passive (external or built-in power supply or other power source), there is a certain role in assisting or alleviating the symptoms or preventing, the potential risk is very small or virtually no risk, no need for special management to ensure that its medical devices are mostly a class of medical equipment; implanted in vivo, in contact with the blood or bodily fluids The medical devices implanted in the body, in contact with blood or body fluids, external power supply, high power, trauma or radiation and other injuries to the human body, play a major diagnostic, therapeutic or other roles, must be used by specialized or trained personnel to operate or manage in order to ensure its safety, effectiveness, the majority of the potential risk of Class III medical devices; the rest are basically Class II medical devices. The number of Class II devices accounted for 60%, and Class I and III each accounted for about 20%. According to the above principles of judgment, eight or nine. For the classification of specific products attributed to the State Food and Drug Administration website in the "Medical Device Classification Catalog".
Question 3: What is the first class of medical devices Hello, the first class of medical devices refers to the routine management of medical devices sufficient to ensure their safety and effectiveness.
In the "Classification of Medical Devices Catalog" in the following classification of a class of medical devices
Basic surgical instruments microsurgical instruments
Neurosurgical instruments ophthalmic surgical instruments
ENT surgical instruments oral surgical instruments
Thoracic cardiovascular surgical instruments abdominal surgical instruments
Urology and anorectal surgery
The first class of medical devices is the first class of medical devices, and the second class is the first class of medical devices, and the third class is the second class of medical devices. p> Urological and intestinal surgical instruments Orthopedic (orthopedic) surgical instruments
Obstetrics and gynecology surgical instruments Family planning surgical instruments
Injection and puncture instruments Burns (plastic) surgical instruments
General diagnostic instruments Medical electronic instruments and equipment
Medical optical instruments, instruments and endoscopic equipment Ultrasound instruments and related equipment
< p> Medical laser instruments and equipment Medical high-frequency instruments and equipmentPhysical therapy and rehabilitation equipment Chinese medicine instruments
Medical magnetic **** vibration equipment Medical X-ray equipment
Medical X-ray accessory equipment and components Medical high-energy radiation equipment
Medical nuclide equipment Medical ray protection supplies, devices
Clinical testing and analysis equipment Medical Laboratory and basic equipment and instruments
Extracorporeal circulation and blood processing equipment implantable materials and artificial organs
Operating room, emergency room, diagnostic and treatment room equipment and appliances stomatology equipment and appliances
Ward care equipment and appliances disinfection and sterilization equipment and appliances
Medical cold therapy, cryogenics, refrigeration equipment and appliances stomatology materials
Medical Hygiene materials and dressings medical suture materials and adhesives
Medical polymer materials and products interventional devices
The following products are Class I medical devices: stethoscopes, percussion hammers, reflective instruments, vision diagnostic instruments, oral knife, chisel, oral pliers, corneal clippers, ophthalmic surgical scissors, ophthalmic tissue scissors, microscopic clippers, micro-gun surgical scissors, micro-tissues clippers, film frames, skyrail Hanger, X-ray photography dark box, shuffle frame, X-ray darkroom equipment
Question 4: What belongs to a class of household medical equipment Household medical equipment in the classification of most of the medical equipment belongs to a class of medical devices, the state control is relatively loose, the application process is also relatively simple, so the feeling is like a general instrumentation, but because it is also an auxiliary means of medical treatment, so it is defined as a Medical devices. For example, many of the following are:
Home health care equipment Pain *** equipment, home health care self-testing equipment, blood pressure monitors, electronic thermometers, multi-function therapeutic instrument, blood glucose meter, vision improvement equipment, sleep improvement equipment, oral health products, adult home health care equipment
Home health care *** products Electric *** chair / bed; ***; *** whack; ** pillow; *** cushion; *** cushion; *** chair / bed; *** whack; *** pillow; *** cushion; *** cushion; *** cushion; *** cushion. *** Pillow; *** Cushion; *** Lumbar Belt; Blood and Qi
Circulation Machine; Foot Bath; Foot *** Appliance; Handheld *** Appliance, *** Bathtub, Fat Dumping Belt;
Therapeutic Instrument; Plantar Physiotherapy Instrument; Weight Loss Belt; Car Seat Cushion; Kneading Cushion; *** Chair; Breast Enhancement Appliance;
Cosmetic *** Appliance.
Home Medical Rehabilitation Equipment Therapeutic Instruments, Kaikang High Potential Therapeutic Instrument, Cervical Spine Therapeutic Instrument, Household Cervical Spine and Lumbar Spine Tractor, Traction Chair, Physiotherapy Instruments, Sleep Instrument, *** Instrument, Functional Chairs, Functional Beds, Supports, Medical Inflatable Air Cushions; Oxygen Generator, Decoctions, Hearing Aids, etc.;
Home Nursing Care Equipment Home Rehabilitation Nursing Care Auxiliary Appliances, Women's Pregnant and Infant Nursing Care Products Family nursing care aids, female pregnancy and infant care products, family supply and delivery equipment; oxygen cylinders, oxygen bags, family first aid kits
Question 5: What is included in a class of medical devices 01.Description of the Classification Catalog of Medical Devices 02.6801 Basic Surgical Instruments
03.6802 Microsurgical Surgical Instruments
04.6803 Neurosurgical Surgical Instruments
05.6804 Surgical Instruments for Ophthalmology
06.6805 Surgical Instruments for Ear, Nose and Throat
07.6806 Surgical Instruments for Oral Surgery
08.6807 Surgical Instruments for Thoracic and Cardiovascular Surgery
09.6808 Surgical Instruments for Abdominal Surgery
10.6809 Surgical Instruments for Uro-anal Surgery
11.6810 Orthopedic (Orthopedic) Surgical Instruments
12.6812 Surgical Instruments for Obstetrics and Gynecology
13.6813 Surgical Instruments for Family Planning
14.6815 Injections and Punctures
15.6816 Surgical Instruments for Burns (Orthopedics)
16.6820 General Diagnostic 17.6821 Medical Electronic Instruments and Equipment
18.6822 Medical Optical Apparatus, Instruments and Endoscopic Devices
19.6823 Medical Ultrasound Instruments and Related Equipment
20.6824 Medical Laser Instruments and Equipment
21.6825 Medical High Frequency Instruments and Equipment
22.6826 Physiotherapy and Physical Therapy and Related Equipment
22.6826 Physical therapy and rehabilitation equipment
23.6827 Instruments for traditional Chinese medicine
24.6828 Magnetic **** vibration equipment for medical use
25.6830 X-ray equipment for medical use
26.6831 X-ray accessory equipment and components for medical use
27.6832 High-energy ray equipment for medical use
28.6833 Nuclide equipment for medical use
29.6834 Radiation protection supplies and devices for medical use
30.6840 Clinical testing and analyzing instruments
31.6841 Instruments for medical testing and basic equipment
32.6845 Extracorporeal circulation and blood processing equipment
33.6846 Implantable materials and artificial organs
33.6847 Implantable materials and artificial organs
34. Materials and artificial organs
34.6854 Operating room, emergency room, diagnostic and treatment room equipment and appliances
35.6855 Dental equipment and appliances
36.6856 Ward care equipment and appliances
37.6857 Sterilization and disinfection equipment and appliances
38.6858 Cold therapy, cryogenic, refrigeration equipment and appliances
38.6858 Cold therapy, cryogenic, refrigeration equipment and appliances
39. Equipment and Apparatus for Medical Cold Therapy, Cryogenics, Refrigeration
39.6863 Stomatological Materials
40.6864 Hygienic Materials and Dressings for Medical Purposes
41.6865 Suture Materials and Adhesives for Medical Purposes
42.6866 Polymer Materials and Products for Medical Purposes
43.6870 Software
44.6877 Interventional Devices
44.6868 Surgical Equipment and Apparatus for Medical Purposes < /p>
Question 6: What is the difference between Class I medical devices and Class II medical devices Medical devices in accordance with the requirements of the State Drug Administration a **** divided into three categories, according to the category of its product requirements are also the higher, of which Class III is the highest, according to the category to divide, mainly because of the different products of its business, such as Class I, mostly for external use of large or small and medium-sized medical devices, the second category of mostly implantable devices such as esophageal stents and other similar products. esophageal stents and other similar products.
Question 7: What is a national class of medical devices? According to the "supervision and management of medical devices regulations" Article IV of the State of medical devices in accordance with the degree of risk of the implementation of classification management.
The first class is a low risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.
Evaluation of the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, methods of use and other factors.
The Food and Drug Administration under the State Council is responsible for formulating the classification rules and classification directory of medical devices, and according to the production, operation and use of medical devices, timely analysis and evaluation of the risk of changes in medical devices, and adjust the classification directory. The development and adjustment of the classification directory shall fully listen to the opinions of the medical device production and operation enterprises as well as the use of units, industry organizations, and reference to the international medical device classification practice. Classification of medical devices catalog should be published to the community.
Question 8: medical devices, a class of two differences between medical device products are divided into three categories: Class I is sufficient to ensure the safety and effectiveness of routine management; Class II refers to the product mechanism has been internationally and domestically recognized, technologically mature, safety and efficacy must be controlled; Class III refers to the implantation of the human body, or used for life support, or the complexity of the technical structure of the human body may have a potentially dangerous, safety and efficacy of the product, and the safety and efficacy of the product. Dangerous, safety
Question 9: What is the registration process for Class I medical devices? Domestic Class I medical device registration and approval process
Domestic Class I medical device registration (re-registration) consists of acceptance, administrative approval process. The total time limit for approval is 30 working days from the date of issuance of the acceptance notice.
I. Acceptance
The main application materials for registration of Class I medical devices within the territory (re-registration) to carry out a formal review to ensure that the application materials are complete and standardized, and announce the acceptance of the situation to the community.
Medical device manufacturers to apply for registration (re-registration) of Class I medical devices within the territory, should be the location of the municipal (food) drug supervision and management department to submit the required registration application materials.
(a) Acceptance requirements
1. "Domestic medical device registration application form"
The applicant company to fill in the submission of the "Domestic medical device registration application form" should be signed by the legal representative and stamped with the official seal, the items filled in should be complete and accurate, fill in the content should be in line with the following requirements:
(1) "Manufacturer", "Name", "Name", "Name", "Name", "Name", "Name", "Name", "Name", "Name", "Name" and "Name". (1) "Manufacturer's name", "registered address" and "industrial and commercial business license" is the same;
(2) "product name", "specifications" and "product standards, test reports". Submitted product standards, test reports and other application materials used in the name, specifications and models consistent.
2. Proof of qualification of medical device manufacturers
Proof of qualification includes a copy of the "Class I Medical Device Manufacturer Registration Form" and a copy of the "industrial and commercial business license".
(1) Application for registration (re-registration) of the product should be in the "Class I Medical Device Manufacturer Registration Form" approved scope of production;
(2) "industrial and commercial business license" in the validity period.
3. Applicable product standards and instructions
The product standards submitted by the applicant enterprise can be national standards, industry standards or registered product standard text.
(1) the use of national standards, industry standards as product standards, should be submitted to the national standards or industry standards adopted by the effective text and the adoption of standardized instructions;
(2) the use of registered product standards as product standards, should be submitted to the official text of the registered product standards and their preparation instructions.
4. Product full performance test report
Product full performance test report should include the following:
(1) product name, specifications, product number or batch number, date of production, number of samples, the sampling base;
(2) the basis for the test, the test project, the standard requirements, the results, the results of the judgment, the inspector, the auditor Signature or seal, date of inspection, etc.;
(3) If the test is commissioned, the commissioned testing organization should be provided with a test report issued by the commissioned inspection agreement.
5. Enterprise production of products of existing resource conditions and quality management capabilities (including testing methods) of the description
Enterprise production of products of existing resource conditions and quality management capabilities (including testing methods) of the description should include the following:
(1) applying for the enterprise's existing resources (human resources, infrastructure, working environment, etc.) conditions, management capacity, production capacity, testing methods and capabilities of the description.
(2) provide a list of production equipment, testing instruments and product testing of measuring instruments required for the validity of the verification certificate (copy).
6. Medical device specifications
Medical device specifications should include at least the following:
(1) product name, model, specifications;
(2) the name of the manufacturer, the registered address, production address, contact information;
(3) "Medical Device Manufacturer's License" No., the number of the certificate of registration of medical devices (the content of the declaration is blank), the product is not required. Declaration of the contents of the blank), the product standard number;
(4) the performance of the product, the main structure, scope of application.
7. Product quality tracking report (chicken for re-registration)
Product quality tracking report should include the following:
(1) the enterprise's quality control measures on the product and the internal audit of the product quality review of the situation;
(2) in the process of using the product, the user of product quality feedback;
(3) product cycle inspection;
(4) the product's performance, main structure, scope of application. > (3) the product cycle test, daily factory inspection of product quality; above the provincial level (food) drug supervision and management department product quality supervision and sampling;
(4) the implementation of the adverse event monitoring system and monitoring of adverse events;
(5) the enterprise to collect information on product quality, statistical analysis and the measures taken and validation of the situation.
8. Original medical device registration certificate (for re-registration)
(1) belonging to the "Measures for the Administration of Registration of Medical Devices" Chapter V, Article 33 of the circumstances, should be submitted to the original certificate of registration of medical devices;
(2) belonging to the "Measures for the Administration of Registration of Medical Devices" Chapter V, Article 34, Article 35 of the circumstances, should be submitted to the original certificate of registration of medical devices. (2) belonging to the "Measures for the Administration of Medical Device Registration" Chapter V, Article 34, Article 35, should submit the original medical device registration certificate.
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Question 10: The difference between Class I, Class II, and Class III medical devices, the best authoritative solution Regulations for the Supervision and Administration of Medical Devices
The People's Republic of China and the State Council Decree No. 276
Article V. The state implements the classification and management of medical devices.
Class I refers to, through routine management is sufficient to ensure the safety and effectiveness of medical devices.
Class II refers to its safety and effectiveness of medical devices should be controlled.
Class III refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
The classification of medical devices by the State Council Drug Administration based on the rules of classification of medical devices, the State Council administrative department of health to develop, adjust and publish.