CFDA Announces Guidelines for Unit Registration of Medical Devices

Nov. 24 Xinhua News November 23, CFDA released the "guidelines for the registration of medical device registration unit," is very detailed, very professional, very useful.

The documents said the registration unit is divided into consideration the product's technical principles, structure, performance indicators, scope and in vitro diagnostic reagents packaging specifications and other factors.

This guideline includes active medical instruments , Passive medical devices and in vitro diagnostic reagent registration unit division guidelines and lists the registration unit division examples, some of the requirements need to be combined with the relevant registered technology review guidelines or standards for comprehensive judgment.

The guidelines are based on the actual situation of the current registration of medical devices developed, with Regulations With the constant improvement of the system, the continuous development of science and technology and the improvement of the level of cognition, the relevant contents of this guiding principle will also be adjusted in due course.

(A) of the technical principles Different active medical devices in principle divided into different registration unit.

(2) The same kind of active medical devices that have the same technical principle but different main structures and compositions of products affect the safety and effectiveness are divided into different registration units in principle.

(C) When the product performance indicators lead to differences in the scope of application or mechanism of action, in principle, divided into different registration units.

(D) The same principles and design of the same technical structure, but the scope of application of products of different types of active medical devices of the same kind, in principle, divided into different registration units.

(5) The passive type consumables used in combination with / combined with the active medical device are, in principle, divided into different registration units with the active medical device.

(F) The same scope of application, need to be used in conjunction with each other but independent of the active medical device is divided into different registration unit in principle .Items for in vitro diagnostic equipment to declare the case exception.

(Vii) Active medical device accessories and connections to use the host as a registered unit in principle to declare.

For separately registered as an annex to the management of medical devices, the annex for different intended use is divided into different registration units in principle, the active and passive accessories are divided into different registration units in principle.If the active and passive accessories in the same Aseptic packaging, in principle, divided into the same registration unit.

(8) Different types of medical devices with similar scope of application, product performance and structure are basically divided into the same registration unit, but if there is a large difference in scope, performance and structure between the models, they are divided into different registrations unit.

(Ix) In-vitro diagnostic instruments with the same product name and different technical principles are, in principle, divided into different registration units.

(10) Modular in vitro diagnostic instruments, single function module products and all functional module products, in principle, are divided into different registration units.

(XI) A number of test functions are included in the same package for a particular instrument, a device of a particular scope of use, a name of a suitable instrument or other alternative name associated with the product, the product being present in combination and, in principle, divided For the same registration unit.

(A) different technical principles of passive medical devices, in principle, divided into different registration unit.

(B) the composition of the product structure

1. Medicinal (active) and non-medicated (active) medical devices are in principle divided into different registration units.

2. Due to the surface treatment or surface structure of different products and the safety of effective, in principle, divided into different registration units.

3. The main product materials, the same scope of application, but different traits affect the safety and effectiveness of products, in principle, divided into different registration units.

4. Active components used with passive medical devices are, in principle, divided into passive registration devices with passive medical devices.

(C) product performance indicators

1. The composition of the product structure or different processing methods lead to different product performance indicators, in principle, divided into different registration unit.

2. Due to the one-time use or reuse lead to different product performance indicators, in principle, divided into different registration units.

3. Due to different sterilization methods lead to different product performance indicators, in principle, divided into different registration unit.

4. Differences in the structure of the key components of a product result in different scopes of application and / or different performance requirements. In principle, different registration units are divided.

5. The main product materials, structural composition, the same scope of application but with its fixed use of different products, and can lead to different product performance indicators, in principle, divided into different registration units.

6. For biogenic products, different types of biological origin of raw materials, in principle, divided into different registration units.

(D) the scope of the product

1. The composition of the product structure or processing methods lead to different product range, in principle, divided into different registration units.

2. The structure of the key components of the product lead to different scope of application, in principle, divided into different registration unit.

3. The structure of the product composition, the same main material but different scope of application, in principle, divided into different registration units.

4. Different product key performance indicators lead to different scope, in principle, divided into different registration units.

5. Product use, the role of different parts lead to different scope of application, in principle, divided into different registration unit.

(E) other

For a combination of tools to be used for the same surgical / nursing purposes, the same registry unit can be declared. When there is a merger declaration of tools with different management categories, the management category of the highest risk product shall prevail.

(A) The registration unit for in vitro diagnostic reagents is, in principle, a single reagent or a single kit, and one registration unit may include different packaging specifications.A single kit refers to all reagents used to perform one or a certain type of test or A kit of parts may be in the form of a kit, and the single reagent refers to all the separate components of the kit that make up the kit. The single kit or the single kit may be declared as a separate registration unit according to need. The kit category The highest category to be considered for its intended use establishes that the type of single agent is based on its own intended use.

(B) a specific test substance reagents (boxes), such as containing different packaging specifications, reagent specifications differ between the specifications of the amount of reagents or the number of tests, in principle, divided into the same registration unit.

(C) specific test substance reagents (boxes), such as containing different packaging specifications, in addition to different specifications between the amount of reagent or test the number of different, suitable for different instrument models or product forms, in principle, divided into Same registration unit.

(D) for specific clinical use, contains a number of test substances and the same principle of test kits, to identify the name of the product associated with the disease or other alternative names, the product in combination form, in principle, can be divided into The same registration unit. Multiple binders in the test substance is limited to the detection of specific indications associated with the diagnostic significance of the relevant test substances.

(E) for a number of different binding test kit permutations and combinations, in principle, divided into the same registration unit.The case of different combinations is limited to each individual test reaction system is relatively independent, not mixed situation.However, a single test kit Due to the product name can not be unified with a number of test kits, it is not recommended with a number of Co-referencing agents divided into the same registration unit.

(6) The calibration products and quality control products can be combined with the in vitro diagnostic reagents used in the application, or they can apply separately for registration. The same registration unit may contain different levels of calibrators and quality control products. The same registration unit may also include Kits containing calibrators, controls and kits without calibrators and controls.

(7) The same registration unit shall have a uniform product name and label, and in vitro diagnostic reagents and in vitro diagnostic instruments can not be declared as the same registration unit.

1. Magnetic resonance imaging equipment, CT machines, X-ray equipment, monitors, ECG machines, endoscopes, laser treatment machines should be divided into different registration units.

2. Semiconductor laser equipment, carbon dioxide laser equipment, Nd: YAG laser equipment should be divided into different registration units.

3. Air-pressurized oxygen tanks and oxygen-pressurized oxygen tanks should be divided into different registration units.

4.Q switch Nd: YAG laser treatment instrument and long pulse Nd: YAG laser treatment instrument, although the working substance and wavelength are the same, but the output energy and output differences lead to performance parameters, the expected use of different, should be divided into different Registration unit.

5. For different scope of application heart Radiofrequency catheter ablation should be divided into different registration units.

6. Different scope of endoscopy, such as arthroscopy and sinusoscopy, hysteroscopy and laparoscopy, should be divided into different registration unit.

7. Hemodialysis equipment and consumables (dialysis tubing, dialyzer, cartridge, etc.) should be divided into different registration units.

8. Syringe pumps and infusion pumps used in conjunction with syringes and infusion sets should be divided into different registration units.

9. Ophthalmic diagnostic products (such as indirect ophthalmoscopes with separate light sources) and therapeutic equipment used in conjunction with ophthalmic laser photocoagulation should be divided into different registration units.

10. High-frequency electrode can be used as a separate registration unit, but also with the high-frequency host as a registration unit.

11. Ultrasonic pneumatic lithotripsy equipment, the most complex models with both ultrasonic lithotripsy and pneumatic lithotripsy, simplified models only with ultrasonic lithotripsy or pneumatic lithotripsy, these three models can be used as a registered unit.

12. Extracorporeal shock wave therapy devices switch the gravel and physiotherapy functions by switching the probe. For grading and physiotherapy-only devices that are obtained through structural simplification, lithotripsy and physiotherapy are of different clinical uses Divided into different registration units.

13. Hematology analyzer, biochemical analyzer, chemiluminescence immunoassay analyzer, enzyme-linked immunoassay analyzer should be divided into different registration unit.

14. Automatic chemiluminescence immunoassay analyzer, using direct chemiluminescence principle and indirect chemiluminescence principle of the product should be divided into different registration unit.

15. Automatic medical PCR analysis system, with monochromatic fluorescent channels and multi-color fluorescent channel products, the performance indicators there is a big difference, should be divided into different registration unit.

16. Modular automatic biochemical immunoassay analyzer, such as reducing the type of biochemical or immune modules, the corresponding product has only a single functional module, should be 'automatic biochemical analyzer' or 'automatic immune analyzer' named.

Because of the different product names, it should be divided into different registration units with only a single functional module product and all functional module products.For the modular automatic biochemical immune analyzer, without increasing the module type, only adding the same type of biochemical or immune module Quantity, the purpose is to improve the detection flux, and the product name, technical principles and scope of application remain unchanged, the performance indicators are similar in this case, should be used as the same registration unit.

17. Electrolyte / blood gas analyzer electrode package, and supporting the electrolyte / blood gas analyzer and kit used in conjunction with the corresponding electrolyte or blood gas detection project, for a number of detection functions of different combinations of products formed should be divided into The same registration unit.But the single test function product can not be unified with multiple test function products because of the product name, it is not recommended to divide the multiple test function products into the same registration unit.

1. Different sizes of gel particles face injection filler, should be divided into different registration unit.

2. Different structure of the intraocular lens should be divided into different registration units, such as one-piece products, three-piece products.

3. Use Different contact lens care products should be divided into different registration units, such as multi-functional care solution, in addition to protease tablets.

4. For intraocular fillings and ophthalmic viscoelastics, products with different chemical compositions or proportions should be divided into different registration units. Products designed with different material molecular weights or molecular weight distributions should be divided into different registration units.

5. Biological fermentation and animal tissue production of sodium hyaluronate produced products should be divided into different registration units.

6. Cobalt-chromium alloy stent, stainless steel stent, nickel-titanium stent, polyethylene stent should be divided into different registration units.

7. Material composition and properties of different viscosity polymer scaffold should be divided into different registration unit.

8. Products containing different coating composition, coating ratio, drug / coating ratio or polymer material composition and intrinsic viscosity of the stent / balloon which are related to the main performance of the product should be divided into different registration units.

9. Scaffolds contained in the drug composition, drug ratio and other products should be divided into different registration unit.

10. Non-degradable stents and biodegradable / absorbent stents should be divided into different registration units.

11. Laminate stent in different materials coated products should be divided into different registration unit.

12. Containing swellable, biodegradable coil spring should be divided into different registration units.

13. Optical design of different intraocular lenses, contact lens products should be divided into different registration units, such as single-focus, multi-focus, ring surface, or a combination of such.

14. Non-branch stents and branched endovascular stents should be divided into different registration units.

15. Compliance, semi-compliant or non-compliant balloon dilatation catheters should be divided into different registration units.

16. IUD according to different product structure (refer to different countries standard ), Different forms of copper (such as copper wire, brass, copper, etc.), different metal components, different copper surface area, with or without silicone rubber components should be divided into different registration units.

17. Temporary filters, permanent filters should be divided into different registration units. Permanent filters in the convertible filters, recyclable filters, non-returnable / convertible filters should be divided into different registration units.

18 cerebrospinal fluid shunt with the electromagnetic pressure regulating system should be divided into different registration units to declare.

19. The implantation of different intraocular lenses should be divided into different registration units: such as the back room, anterior chamber and so on.

20. Abdominal aorta, thoracic aortic stent should be divided into different registration units.

21. Coronary artery balloon dilatation catheter, peripheral artery balloon dilatation catheter, aortic balloon dilatation catheter, aortic balloon balloon catheter and mitral balloon dilation catheter should be divided into different registration units.

22. In vitro assisted reproductive liquid medical devices, different ratio (concentration) products should be divided into different registration units.

1. Urine microalbumin detection kit (immune turbidimetry), including 30 copies / box, 50 copies / box, two packaging specifications apply to different instrument models, should be divided into the same registration unit.

2. Bar and card morphine detection reagent (colloidal gold method) should be divided into the same registration unit.

3. Hepatitis B virus five joint detection card (colloidal gold method) for the qualitative detection of human serum, plasma hepatitis B virus surface antigen, surface antigen, e antigen, e antibody, the core antibody, the diagnosis of specific indications are coordinated Significance, should be divided into the same registration unit.

4. Drug test strips, five test strips and three of the test strips can be used as the same registration unit. No matter whether it is five or three, the individual tests do not interfere with each other and are different There is no difference in the performance between the test strips. For example, as the same registration unit, all the technical information submitted during the application for all five tests can cover all the products.

The name of the product should be unified as the name of the indication related to the product, such as the "multiple drug detection kit (colloidal gold method)." A plurality of detection reagents for the chip hybridization method, each test object ) Single-reaction PCR method for a number of detection reagents, the same can be different combinations as the same registration unit.

5. Kits and calibrators, quality control should be used as the same registration unit situation: C-reactive protein detection kit (turbidimetric method), without calibration, quality control, can be used as a separate registration unit; C-reactive protein detection Kit (turbidimetric method), the cartridge contains, in addition to the test reagent, a corresponding calibrator and / or control, which can be used as a separate registration unit; these two combinations can be used as the same registration unit; separate calibrators Or controls (which can include different levels) can be used as a separate registration unit.