China NMPA Certification (CFDA)

Short Description:

JJR Laboratories provides professional NMPA (CFDA) certification services that will help your medical device products be brought to China market faster

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About JJR Laboratory:

JJR lab provide professional certification services that will help get your products to market faster, enabling greater sales and revenue. For technical regulation support, technicians at JJR are able to help you understand technical regulations and product design specifications.

Communicate with our experts to determine your needs and we will provide you with an evaluation, proposal and quotation.

What is NMPA certification?

The NMPA 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.


The CFDA certification has been changed to an NMPA certificate. 


Applicable Products:

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.


According to the medical device production supervision and management measures promulgated by the CFDA, to establish a second and third category medical device manufacturing enterprises in China, a medical device manufacturing enterprise license must be obtained.


According to the medical device registration management measures promulgated by CFDA, any manufacturer wishing to sell and use medical devices (including domestic and overseas devices) in China should register with the corresponding food and drug regulatory authority.


Why Choose Us?

JJR Lab, accredited by CNAS, CMA, CNCA & A2LA, consistently operates competently and generates accurate and valid results in accordance with ISO/IEC 17025. We are also IECEE CB Scheme Test Laboratory (CBTL). Thus, testing reports from JJR Lab can be accepted between countries.

JJR Lab (Shenzhen HuaTongWei International Inspection Co., Ltd.) is a subsidiary of CCIC Group (China Certification & Inspection Group).We are the authoritative CCC certification service provider (third party laboratory) in China. 


Your Benefits at a Glance:

1.20 Years of experience

JJR has extensive experience in all types of devices and regulatory requirements across markets. 

2.Provide free modification service

Together with our wealth of knowledge in complex regulations globally, JJR provides a complete suite of testing solutions according to your needs including free modification service.

3.Save time to global markets

With over 7,000 square meters of labs, JJR offers the best testing cycles and you don't have to wait in line, JJR offers 1-on-1 service.With our in-depth insight of global product quality and regulatory requirements, JJR can optimize your costs and minimize your time to market.

4.Complete qualifications

ISO/IEC 17025 lab, accreditated by CNAS, CMA,A2LA,GLP.

5.Competitve price

Located in China ,testing costs are lower than other labs.


We're Here for You

We're based in China but regularly work with clients globally. We will get back to you in 1 working day.



You can also contact us directly by email.


CFDA Standards

1、Active | EMC, safety regulations, performance, environment:


Product/Product   Category

Test   standard and number


Electromagnetic   compatibility requirements for medical electrical equipment

IEC/EN   60601-1-2; YY0505


Safety   requirements for medical electrical equipment

IEC/EN   60601-1; GB 9706.1

ES   60601-1; CSA-C22.2No.601-1


Medical   electrical equipment or systems used in home healthcare environments

IEC/EN   60601-1-11


High   frequency electrosurgical equipment and its accessories

IEC/EN   60601-2-2; GB9706.4


Nerve   and muscle stimulator

IEC/EN   60601-2-10; YY0607


Syringe   pump and controller

IEC/EN   60601-2-24; GB9706.27



IEC/EN   60601-2-25; GB10793


ECG   monitoring equipment

IEC/EN   60601-2-27; EC13; GB9706.25; YY1079


Automatic   circulation indirect blood pressure monitoring equipment

EN1060-1;   EN1060-3; ISO 81060-1

IEC/EN   80601-2-30; YY0667; YY 0670


Invasive   blood pressure monitoring equipment

IEC   60601-2-34; YY0783


Heating   equipment and medical heating equipment used in blankets, cushions and   mattresses

IEC/EN80601-2-35;   YY 0834


Ultrasound   medical diagnosis and monitoring equipment

IEC/EN   60601-2-37; GB9706.9


Electronic   myograph and evoked response equipment



Operating   table

IEC/EN   60601-2-46; YY0570


Mobile   ECG system

IEC/EN   60601-2-47; YY 0885


Multifunctional   patient monitoring equipment

IEC   80601-2-49; IEC/EN 60601-2-49; YY0668


Medical   bed

IEC/EN   60601-2-52; YY0571


Dental   equipment

IEC/EN   60601-2-60


Medical   pulse photoelectric oximeter equipment

ISO80601-2-61;   YY 0784


Hearing   aids and hearing systems

IEC/EN   60601-2-66


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


Medical   supply unit (suspension bridge, suspension tower)



Environmental   requirements and test methods for medical electrical equipment



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


Safety   requirements for electrical equipment for measurement, control and laboratory   use

IEC/EN   61010-1; GB4793.1


Laboratory   diagnostics (IVD) medical equipment

IEC/EN   61010-2-101; YY 0648


Experimental   equipment for material heating

IEC/EN   61010-2-010; GB 4793.6


Automatic   or semi-automatic laboratory equipment for analysis or other purposes

IEC/EN   61010-2-081; GB 4793.9


2. Non-active | Biocompatibility:





In   vitro cytotoxicity test

ISO10993-5,   GB16886.5


Sensitization   test

ISO10993-10,   GB16886.10


Skin,   intradermal, oral mucosa irritation test

ISO10993-10,   GB16886.10


Stimulus   test



Acute   systemic toxicity test

ISO10993-11,   GB16886.11


Subacute   systemic toxicity test

ISO10993-11,   GB16886.11


Subchronic   systemic toxicity test

ISO10993-11,   GB16886.11


Chronic   systemic toxicity test

ISO10993-11,   GB16886.11


Heat   source test

ISO10993-11,   GB16886.11


Chromosome   aberration test

ISO10993-3,   GB16886.3


Micronucleus   test

ISO10993-3,   GB16886.3


Gene   mutation test

ISO10993-3,   GB16886.3


Ames   test

ISO10993-3,   GB16886.3


Thrombosis   test

ISO10993-4,   GB16886.4


Coagulation   test

ISO10993-4,   GB16886.4


Platelet   adhesion test

ISO10993-4,   GB16886.4


Complement   activation test

ISO10993-4,   GB16886.4


Hemolysis   test

ISO10993-4,   GB16886.4


Muscle   implant test

ISO10993-6,   GB16886.6


Subcutaneous   implantation test

ISO10993-6,   GB16886.6


Bone   implantation test

ISO10993-6,   GB16886.6


Material   characteristics analysis



Related Regulation:

Regulations   on the supervision and administration of medical devices 

Order   No. 680 of the State Council

Medical   device registration management method 

State   Food and Drug Administration No.4

Management   method for registration of in vitro diagnostic reagents 

State   Food and Drug Administration No.5

Regulations   on the management of instructions and labels of medical devices 

State   Food and Drug Administration No.6

Supervision   and management method of medical device production

 State   Food and Drug Administration No.7

Management   method of medical device operation supervision 

State   Food and Drug Administration No.8

Medical   device classification rules

 State   Food and Drug Administration No.15

Code   for quality management of clinical trials of medical devices 

State   Food and Drug Administration No.25

Announcement   on the requirements of medical device registration application materials and   the format of approval documents 

State   Food and Drug Administration Announcement No. 43, 2014

Announcement   on the requirements for registration and application data of in vitro   diagnostic reagents and the format of approval documents 

Announcement   No. 44, 2014 of State Food and Drug Administration

Guiding   principles for preparation of technical requirements for medical device   products 

State   Food and Drug Administration Circular No.9, 2014


We provide NMPA certification registration inspection services

We provide efficient and smooth pre-testing and rectification services.

We provide agency services and quickly obtain NMPA certificates in one stop.


NMPA certification registration procedures:

1. Write product standards.

2. Coordinate with NMPA testing center and obtain test report

3. If necessary, conduct clinical trials.

4. Submit an application to NMPA.

5. NMPA technical document review.

6. Obtained NMPA registration.


Information to be submitted for medical NMPA certification:

(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.

Service Procedure

1. Provide us with product pictures, product brochures/manuals

2. Determine your needs(test report purpose/ test itmes/ standards)

3. Receive the testing/compliance service proposal and quotation 

4. Sign contract and make payment

5.Send samples (please contact us for address info.)

6.Informed project opening and test TAT(turn around time) via email


8.Draft report for your confirmation

9. Formal reports endorsed by ILAC - CNAS (electronic version) 

10.Sample Discard or Return

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