What's New
CIRS Group Opens Shanghai Office
On January 16, 2023, CIRS Group announced the opening of a new office in Shanghai, as it continues its expansion into the global market.
Located in the heart of Pudong – Shanghai's central business district – the Shanghai Office will devote itself to providing timely and sound product compliance services and solutions to clients in Shanghai and the surrounding areas.
Statistics on the Clinical Trial Data of Quantitative Detection Products of In Vitro Diagnostic Reagents
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.
What Data Should be Submitted to Prove the Hemostatic Mechanism of Absorbable Hemostatic Products in China?
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.
Announcement on Relevant Matters Concerning the Production of Imported Medical Devices by Enterprises in China
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:
On What Conditions Can Surgical Instruments Be Exempted From Biological Tests?
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.
Regulations on the Reference of Clinical Trial Data in China
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?
Is It Possible to Choose A Single-group Target Value Design for Clinical Trials of Intracranial Drug-coated Balloon Dilatation Catheters?
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.
What are the Requirements for Anticoagulants Used in Clinical Trials of In Vitro Diagnostic Reagents?
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.
About the Measurement Function in the Medical Device Software, What Issues Should be Concerned About in the Registration Application Data?
Registration applicants are required to provide research data on measurement accuracy and inform users in the instructions.
Sharing Our Experience: Successfully Completing Regular Registration for New Chemical Substances in China
Recently, CIRS Group once again successfully helped clients complete a regular registration under MEE Order No. 12. And the results have been notified on the MEE website.
Company News
CIRS Group Opens Shanghai Office
Feb 02, 2023
Sharing Our Experience: Successfully Completing Regular Registration for New Chemical Substances in China
Nov 22, 2022
Good News: CIRS Group Completed its First LR Project under the KKDIK (Turkey REACH)
Nov 18, 2022
CIRS Korea Registered as Environmental Consulting Company under the Environmental Technology and Industry Support Act
Sep 06, 2022
CIRS Group Unveils its New Visual Identity
Aug 05, 2022
CIRS Korea has Passed the ISO Certification Audit
Jun 09, 2022
CIRS Group Concludes Cooperation Agreement with Leading Ag CRO SynTech Research Group
Feb 24, 2022
CIRS Group Certificates & Reports Verification System (CRV System) Officially Goes Online
Dec 30, 2021