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Industry News
In order to help Korean companies that want to export cosmetic medical devices to China, the Korea Medical Device Industry Association and CIRS Group Korea will hold a seminar on on Cosmetic Medical Device's Development Trends and Registration Process in China.
Policy Interpretation – How to Enter the "Fast Track" of Priority Approval?
——This policy was implemented on January 1, 2017
1. Scope of priority approval
Projects those are applicable to the priority approval of "fast track"
a. Applications for registration of domestic Class III medical devices.
b. Applications for registration of imported Class II and Class III medical devices.
Projects those are not applicable to the "fast track" of Priority Approval
a. Filing of Class I medical devices;
b. Applications for registration renewal and registration change;
c. Applications that have been included in the approval process in accordance with the emergency approval procedures for medical devices or the special approval procedures for innovative medical devices.
2. The conditions for applying for priority approval
(1) Diagnose or treat rare diseases, with obvious clinical advantages.
(2) Diagnose or treat malignant tumors, with obvious clinical advantages.
(3) Diagnose or treat specific and multiple diseases to the elderly, and there are currently no effective diagnoses or treatments.
(4) Dedicated to children, with obvious clinical advantages.
(5) Clinically urgently needed, and for which there are no registered medical devices of the same species in China.
(6) Medical devices listed in major national science and technology projects or national key research and development programs.
(7) Other medical devices that should be prioritized for approval, shall be determined by NMPA after extensively soliciting of opinions and organizing experts to demonstrate.
3. When is the priority approval application submitted?
Those who meet the above priority approval conditions shall submit the application for priority approval together with the registration application for medical devices.
For quantitative detection products, appropriate statistical analysis methods such as regression analysis should be selected according to the detection performance of the products for clinical trial results. Within a reasonable confidence interval, investigate whether there was a significant correlation and whether there is a significant statistical difference in the results of quantitative values.
If possible, the recommendation should be taken into account that the possible differences in the performance of reagents in different sample concentration intervals, the overall concentration range is subject to interval stratified statistics, and the results in different concentration intervals were analyzed for correlation to better verify the correlation between the two reagents.
In order to prove the hemostatic mechanism of absorbable hemostatic products in China the applicant must submit technical or supporting data that can effectively prove or explain the principle of hemostatic action of the declared product.
It must:
clarify the hemostatic mechanism of the declared product in detail,
describe how the product affects the hemostatic process,
the advantages of the product in the hemostatic process, and
confirm whether the application of this hemostatic mechanism combined with the declared product is scientific and reasonable.
The applicant must review the domestic and foreign research literature supporting the hemostasis principle, and submit the original text and Chinese translation of the relevant scientific literature specifically supporting the hemostasis principle. The applicant must also clarify whether there are products applying the same hemostasis principle on the domestic and foreign markets, and also study whether the declared product may cause thrombosis, coagulation disorders, and other adverse reactions related to its use.
On September 18, 2020, the National Medical Products Administration issued the Announcement on Relevant Matters Concerning the Production of Imported Medical Devices by Enterprises in China No.104 of 2020.
The purpose was to further implement the State Council's Opinions on Reforming the Review and Approval System for Pharmaceutical and Medical Devices and Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices.
As well as to implement the reform of "streamlined administration and delegated power, improve regulations, and upgrade services" and the requirements for optimizing the business environment, comprehensively deepening the reform of the medical device review and approval system, promote the high-quality development of the medical device industry, and better meet the public health needs.
This article explains the announcement which covers the production of products with an imported medical device registration certificate in China:
Based on the current level of knowledge, biological tests can be exempted if the following conditions are satisfied:
Material chemical composition verification data are provided.
The production process does not affect the chemical composition of the material, verification data can be submitted in the form of a material list of raw materials.
The materials used in surgical instruments that come into contact with patients (directly or indirectly) are only composed of metals.
Metal materials are verified to meet the relevant national, industrial and international standards for metallic materials for surgical implants or materials for surgical instruments, as well as the brand specified in applicable national and industrial standards for specific products. For example, the material brand specified in YY/T 0176 General Technical Conditions for Medical Scissors.
1 Whether the non-Chinese clinical trial data of the product must fully meet the requirements of
the corresponding Chinese guidelines or not?
2 Can I select similar products as the control products according to Chinese regulations?
3 Is it necessary to include the Chinese trial data in the non-Chinese clinical trial data ?
4 Are the medical devices required to carry out clinical trials in China?
A single-group target value design can be considered when test device is technically mature and the disease for which it is intended is well understood, or when it is objectively infeasible to set up a control group
We recommend choosing RCT trial design for clinical trial, according to technical development and clinical application status of intracranial drug-coated balloon dilatation catheter, which does not conform to the basic principle of single-group target value design.
When different anticoagulants are involved in the test samples of in vitro diagnostic reagents, different anticoagulants should be studied in the preclinical research stage to verify the applicability of anticoagulants and their impact on the test.
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