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What is a medical device as defined in China (CFDA (NMPA))

Medical device as defined in the Chinese Medical Device Regulations refers to any equipment, apparatus, device, material or other article, alone or in combination. It does not constitute a major activity in or in the human body according to pharmaceutical, immunological, or metabolism, but can support its function in this way.

• Purpose of use of medical devices

Diagnosis, prevention, monitoring, treatment or alleviation of disease;

Diagnosis, monitoring, treatment, alleviation, alleviation or supplementation of an injury or disability condition;

study, substitution or modification of anatomy or physiology;

Control of pregnancy

• Classification of medical devices

Classification of medical devices Medical Device Definition and Class Scope Registration and administrative supervision (Imports in China)
Class 1 Medical devices whose safety and effectiveness are recognized through normal regulations CFDA (NMPA) report
- It takes about 3 months (no test required)
Class 2 Medical devices that require additional management (control function) to ensure safety and effectiveness CFDA (NMPA) registration
- It takes about 1 year or more (including trial period/clinical trial period separate)
Class 3 Medical devices that are used for human insertion, life support, and maintenance, pose a potential risk to the human body, and require strict management of safety and effectiveness CFDA (NMPA) registration
- It takes about a year and a half (including trial period/ separate clinical trial period)

Medical device export license registration procedure required by China (CFDA (NMPA))

① Confirmation of product notification type
② Product classification (Class 1, 2, 3)
③ Submit required documents from the manufacturer
④ Document organization and translation
⑤ Preparation of technical documents
⑥ Clinical trial execution and report acquisition
⑦ Execution of tests and obtaining test results at the test institute
⑧ Receive notification of receipt after filing with CFDA (NMPA)
⑨ If more than 90% of the technical review period has elapsed at the Medical Device Review Center, a supplementary official letter may be received.
⑩ CFDA (NMPA) administrative review
⑪ Receive registration certificate

Documents to be submitted for export license to China (CFDA(NMPA))

No. List of documents to be submitted
1 Medical device registration application
2 manufacturing license
3 ISO 13485 Certificate
4 Product license obtained from the country of manufacture (MFDS product license in Korea)
5 technical requirements
6 user manual
7 Test reports issued by domestic testing institutes in China (corresponding to grades 2 and 3)
8 Clinical evaluation data / Safety and efficacy data / Risk management report
9 Product Quality Assurance Certificate (Issued by the manufacturing industry, guaranteeing the same quality of products sold in the country of manufacture and China)
10 A letter of consignment for an agent in China, a letter of approval from the agent, a business registration certificate and a certificate of business registration
11 A statement of self-assurance for the veracity of the submitted documents

• Document Requirements

Report data are organized and submitted in the prescribed order

Display the order by attaching a label on the right side of the first page of each report data item

Documents submitted by companies should be printed in A4 size, and documents submitted to government and other organizations should be submitted in original size.

A copy of the report must be clear and must match the original

All foreign language materials (except name and address) received among the reported data must be translated into Chinese and the translation must be attached to the back of the original document (translations must be signed by the producer or a registration agency authorized by the producer) box)

The method of entry for the same item in the report data must match and there must be no contradiction.

The general name of the product used should be used for the product name in the report data, and if there is a product name, the product name should be indicated. General name and product name are subject to registration certificate management

• Documents to be submitted during clinical trials

test subject List of documents to be submitted
Medical devices excluded from the Medical devices whose raw materials have never been used in China A medical device in which the medical device is inserted into the human body for the first time Medical device clinical trial application
Registered product standard / country, industry standard
Product self-measurement report
Product type test plan report submitted by a testing institution approved by CFDA (NMPA)
Product type test plan report submitted by a testing institution approved by CFDA (NMPA)
Clinical Trial Plan
sample or photo

Medical device clinical trials required by China (CFDA (NMPA))

• What is a clinical trial?

- It refers to the process of using or verifying the safety and effectiveness of a medical device that has been registered for registration by a medical institution (hereinafter referred to as a medical institution) that has received medical device clinical trial qualifications in accordance with regulations under normal conditions of use. The purpose of evaluation is to evaluate whether the test product has the expected safety and efficacy.

• Clinical Trial Prerequisites

No. Contents
1 The product needs to pass the examination of the registered product standard or the relevant national industry standard
2 Product self-measurement report
3 There must be a product type test report submitted by the Food and Drug Administration Department under the State Council and the inspection agency recognized by the Mass Technology Supervision Department under the State Council, and the result must be a pass.
4 If the test product is a medical device to be inserted into the human body for the first time, an animal test report of the product is required. For products that require confirmation of the safety of the product in human clinical trials through other animal tests, an animal test report must be submitted.

• Clinical trial report

Analysis of the type of disease tested, the total number of cases and the gender, age, and team of cases, and establishment of a control team (if necessary)

Clinical trial method

Adopted statistical methods and evaluation methods

Clinical evaluation standard

Clinical trial results

Clinical trial conclusion

Bad events, side effects and treatment status during clinical trials

Clinical trial effect analysis

Application symptoms, scope of application, prohibitions and cautions

Problems and suggestions for improvement

美国 CERT 能够通过与相关组织的合作，提供定制化的技术支持，以满足客户在出口许可证和医疗器械对华许可证（CFDA（NMPA））方面的需求和法律要求。