Contact Us
Find out more about service
Contact us

China NMPA Certification (CFDA)

About HTW Lab:

HTW 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 HTW 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?

HTW 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 HTW Lab can be accepted between countries.


Your Benefits At A Glance:

1.20 Years Of Experience

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

2.Provide Free Modification Service Program

Together with our wealth of knowledge in complex regulations globally, HTW 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, HTW offers the best testing cycles and you don't have to wait in line, HTW offers 1-on-1 service.With our in-depth insight of global product quality and regulatory requirements, HTW 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.


    Our Business Hours: 

    8.30am - 5.00pm in CST (UTC/GMT+08:00) Monday - Friday 


    Email:

    sales@htwlab.com

    Kindly tell us ‘how did you hear about us’.

    HTW Testing and Certification Solutions.

    Standards

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

    NO.Product/Product CategoryTest standard and number
    1Electromagnetic compatibility requirements for medical electrical equipmentIEC/EN 60601-1-2; YY0505
    2Safety requirements for medical electrical equipmentIEC/EN 60601-1; GB 9706.1
    ES 60601-1; CSA-C22.2No.601-1
    3Medical electrical equipment or systems used in home healthcare environmentsIEC/EN 60601-1-11
    4High frequency electrosurgical equipment and its accessoriesIEC/EN 60601-2-2; GB9706.4
    5Nerve and muscle stimulatorIEC/EN 60601-2-10; YY0607
    6Syringe pump and controllerIEC/EN 60601-2-24; GB9706.27
    7ElectrocardiographIEC/EN 60601-2-25; GB10793
    8ECG monitoring equipmentIEC/EN 60601-2-27; EC13; GB9706.25; YY1079
    9Automatic circulation indirect blood pressure monitoring equipmentEN1060-1; EN1060-3; ISO 81060-1
    IEC/EN 80601-2-30; YY0667; YY 0670
    10Invasive blood pressure monitoring equipmentIEC 60601-2-34; YY0783
    11Heating equipment and medical heating equipment used in blankets, cushions and mattressesIEC/EN80601-2-35; YY 0834
    12Ultrasound medical diagnosis and monitoring equipmentIEC/EN 60601-2-37; GB9706.9
    13Electronic myograph and evoked response equipmentIEC/EN60601-2-40
    14Operating tableIEC/EN 60601-2-46; YY0570
    15Mobile ECG systemIEC/EN 60601-2-47; YY 0885
    16Multifunctional patient monitoring equipmentIEC 80601-2-49; IEC/EN 60601-2-49; YY0668
    17Medical bedIEC/EN 60601-2-52; YY0571
    18Dental equipmentIEC/EN 60601-2-60
    19Medical pulse photoelectric oximeter equipmentISO80601-2-61; YY 0784
    20Hearing aids and hearing systemsIEC/EN 60601-2-66
    21Special requirements for human body temperature monitoring equipmentEN5070-3; EN5070-4; EN5070-5
    ISO80601-2-56; IEC/EN80601-2-59
    ASTM E1112; ASTM E1965; GB/T 21416; GB/T 21417.1
    22Medical supply unit (suspension bridge, suspension tower)ISO11197
    23Environmental requirements and test methods for medical electrical equipmentGB/T14710
    24Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory useIEC/EN 61326-1; IEC/EN 61326-2-6
    GB/T18268.1; GB/T18268.26
    25Safety requirements for electrical equipment for measurement, control and laboratory useIEC/EN 61010-1; GB4793.1
    26Laboratory diagnostics (IVD) medical equipmentIEC/EN 61010-2-101; YY 0648
    27Experimental equipment for material heatingIEC/EN 61010-2-010; GB 4793.6
    28Automatic or semi-automatic laboratory equipment for analysis or other purposesIEC/EN 61010-2-081; GB 4793.9



    2. Non-active | Biocompatibility:

    NO.ProjectStandard
    1In vitro cytotoxicity testISO10993-5, GB16886.5
    2Sensitization testISO10993-10, GB16886.10
    3Skin, intradermal, oral mucosa irritation testISO10993-10, GB16886.10
    4Stimulus testISO10993-23
    5Acute systemic toxicity testISO10993-11, GB16886.11
    6Subacute systemic toxicity testISO10993-11, GB16886.11
    7Subchronic systemic toxicity testISO10993-11, GB16886.11
    8Chronic systemic toxicity testISO10993-11, GB16886.11
    9Heat source testISO10993-11, GB16886.11
    10Chromosome aberration testISO10993-3, GB16886.3
    11Micronucleus testISO10993-3, GB16886.3
    12Gene mutation testISO10993-3, GB16886.3
    13Ames testISO10993-3, GB16886.3
    14Thrombosis testISO10993-4, GB16886.4
    15Coagulation testISO10993-4, GB16886.4
    16Platelet adhesion testISO10993-4, GB16886.4
    17Complement activation testISO10993-4, GB16886.4
    18Hemolysis testISO10993-4, GB16886.4
    19Muscle implant testISO10993-6, GB16886.6
    20Subcutaneous implantation testISO10993-6, GB16886.6
    21Bone implantation testISO10993-6, GB16886.6
    22Material characteristics analysisISO10993-18



    Others

    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

    7.Testing 

    8.Draft report for your confirmation

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

    10.Sample Discard or Return

    Contact Us
    First name*
    Last Name*
    Job title
    Company name
    Email address*
    Phone number
    Message*
    HTW Lab
    Product Testing and Certification

    Call: 86-0755-26748009

    Email: sales@htwlab.com


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

    Address: 1/F, Bldg5, Hongfa Hi-tech Industrial Park, Tianliao, Guangming, Shenzhen City, Guangdong Province, P.R. China 

    ISO/IEC 17025 Accredited. 
    CNAS.

    ILAC.
    GLP Laboratory.
    CMA.
    A2LA.

    CBTL.