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Applicable Products

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.


Introduction

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.

Standards

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


Others


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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