China NMPA Certification (CFDA)
About HTW Laboratory:
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.
HTW 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
HTW 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, 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.
Email:
You can also contact us directly by email.
HTW Testing and Certification Solutions.
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 |
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 efficient and smooth pre-testing and rectification services.
We provide agency services and quickly obtain NMPA certificates in one stop.
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.
(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.
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