The CFDA certification has been changed to an NMPA certificate. In China, the regulatory requirements for medical devices are established through the "Regulations on the Supervision and Administration of Medical Devices". The institutions responsible for the supervision of medical devices are the State Food and Drug Administration (CFDA) and the provincial and municipal drug administrations And each branch.
The CFDA is formed by integrating the responsibilities of the Food Safety Office, the responsibilities of the Food and Drug Administration, the production-level food safety supervision and management responsibilities of the General Administration of Quality Supervision, Inspection and Quarantine, and the circulation-level food safety supervision and management responsibilities of the State Administration for Industry and Commerce. It is responsible for drugs, medical devices, and cosmetics. And supervision and management of food safety in the consumer sector. CFDA was formally established on March 22, 2013, and Zhang Yong, director of the Office of the Food Safety Commission of the State Council, served as the first director and party secretary of the State Food and Drug Administration.
1、Active | EMC, safety regulations, performance, environment:
| NO. | Product/Product Category | Test standard and number |
| 1 | Electromagnetic compatibility requirements for medical electrical equipment | IEC/EN 60601-1-2; YY0505 |
| 2 | Safety requirements for medical electrical equipment | IEC/EN 60601-1; GB 9706.1 |
| ES 60601-1; CSA-C22.2No.601-1 | ||
| 3 | Medical electrical equipment or systems used in home healthcare environments | IEC/EN 60601-1-11 |
| 4 | High frequency electrosurgical equipment and its accessories | IEC/EN 60601-2-2; GB9706.4 |
| 5 | Nerve and muscle stimulator | IEC/EN 60601-2-10; YY0607 |
| 6 | Syringe pump and controller | IEC/EN 60601-2-24; GB9706.27 |
| 7 | Electrocardiograph | IEC/EN 60601-2-25; GB10793 |
| 8 | ECG monitoring equipment | IEC/EN 60601-2-27; EC13; GB9706.25; YY1079 |
| 9 | Automatic circulation indirect blood pressure monitoring equipment | EN1060-1; EN1060-3; ISO 81060-1 |
| IEC/EN 80601-2-30; YY0667; YY 0670 | ||
| 10 | Invasive blood pressure monitoring equipment | IEC 60601-2-34; YY0783 |
| 11 | Heating equipment and medical heating equipment used in blankets, cushions and mattresses | IEC/EN80601-2-35; YY 0834 |
| 12 | Ultrasound medical diagnosis and monitoring equipment | IEC/EN 60601-2-37; GB9706.9 |
| 13 | Electronic myograph and evoked response equipment | IEC/EN60601-2-40 |
| 14 | Operating table | IEC/EN 60601-2-46; YY0570 |
| 15 | Mobile ECG system | IEC/EN 60601-2-47; YY 0885 |
| 16 | Multifunctional patient monitoring equipment | IEC 80601-2-49; IEC/EN 60601-2-49; YY0668 |
| 17 | Medical bed | IEC/EN 60601-2-52; YY0571 |
| 18 | Dental equipment | IEC/EN 60601-2-60 |
| 19 | Medical pulse photoelectric oximeter equipment | ISO80601-2-61; YY 0784 |
| 20 | Hearing aids and hearing systems | IEC/EN 60601-2-66 |
| 21 | Special requirements for human body temperature monitoring equipment | EN5070-3; EN5070-4; EN5070-5 |
| ISO80601-2-56; IEC/EN80601-2-59 | ||
| ASTM E1112; ASTM E1965; GB/T 21416; GB/T 21417.1 | ||
| 22 | Medical supply unit (suspension bridge, suspension tower) | ISO11197 |
| 23 | Environmental requirements and test methods for medical electrical equipment | GB/T14710 |
| 24 | Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use | IEC/EN 61326-1; IEC/EN 61326-2-6 |
| GB/T18268.1; GB/T18268.26 | ||
| 25 | Safety requirements for electrical equipment for measurement, control and laboratory use | IEC/EN 61010-1; GB4793.1 |
| 26 | Laboratory diagnostics (IVD) medical equipment | IEC/EN 61010-2-101; YY 0648 |
| 27 | Experimental equipment for material heating | IEC/EN 61010-2-010; GB 4793.6 |
| 28 | Automatic or semi-automatic laboratory equipment for analysis or other purposes | IEC/EN 61010-2-081; GB 4793.9 |
2、Non-active | Biocompatibility:
| NO. | Project | Standard |
| 1 | In vitro cytotoxicity test | ISO10993-5, GB16886.5 |
| 2 | Sensitization test | ISO10993-10, GB16886.10 |
| 3 | Skin, intradermal, oral mucosa irritation test | ISO10993-10, GB16886.10 |
| 4 | Stimulus test | ISO10993-23 |
| 5 | Acute systemic toxicity test | ISO10993-11, GB16886.11 |
| 6 | Subacute systemic toxicity test | ISO10993-11, GB16886.11 |
| 7 | Subchronic systemic toxicity test | ISO10993-11, GB16886.11 |
| 8 | Chronic systemic toxicity test | ISO10993-11, GB16886.11 |
| 9 | Heat source test | ISO10993-11, GB16886.11 |
| 10 | Chromosome aberration test | ISO10993-3, GB16886.3 |
| 11 | Micronucleus test | ISO10993-3, GB16886.3 |
| 12 | Gene mutation test | ISO10993-3, GB16886.3 |
| 13 | Ames test | ISO10993-3, GB16886.3 |
| 14 | Thrombosis test | ISO10993-4, GB16886.4 |
| 15 | Coagulation test | ISO10993-4, GB16886.4 |
| 16 | Platelet adhesion test | ISO10993-4, GB16886.4 |
| 17 | Complement activation test | ISO10993-4, GB16886.4 |
| 18 | Hemolysis test | ISO10993-4, GB16886.4 |
| 19 | Muscle implant test | ISO10993-6, GB16886.6 |
| 20 | Subcutaneous implantation test | ISO10993-6, GB16886.6 |
| 21 | Bone implantation test | ISO10993-6, GB16886.6 |
| 22 | Material characteristics analysis | ISO10993-18 |
registration procedures:
1. Write product standards.
2. Coordinate with CFDA testing center and obtain test report
3. If necessary, conduct clinical trials.
4. Submit an application to CFDA.
5. CFDA technical document review.
6. Obtained CFDA registration.
Information to be submitted :
(1) Application form for domestic medical device registration;
(2) Qualification certificate of medical device manufacturer: a copy of business license;
(3) Applicable product standards and descriptions:
Where national standards and industry standards are adopted as applicable standards for products, the text of the adopted national standards and industry standards shall be submitted; the registered product standards shall be signed and sealed by the manufacturer.
The manufacturer shall provide a statement that the applied product conforms to the national standards and industry standards, the statement that the manufacturer assumes the quality responsibility after the product goes on the market, and the description of the product model and specifications.
The "signature" here refers to: the company's seal, or the signature of its legal representative or person in charge plus the company's seal (the following is the same meaning when it involves domestic medical devices);
(4) Product full performance test report;
(5) A description of the current resource conditions and quality management capabilities (including testing methods) of the products produced by the enterprise;
(6) Instructions for medical devices;
(7) Self-assurance statement of the authenticity of the submitted materials:
It should include a list of submitted materials and a commitment by the manufacturer to assume legal responsibility.
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