Service Items

Service Items

Study on the applicability of non professionals

Applicable products domestic and foreign medical devices and in vitro diagnostic products. It can provide CMA CNAs qualified product quality and safety inspection report, performance inspection report and functionality. Test report, quality appraisal, hygienic evaluation report, physical performance test, component analysis, chemical test, EMC test,

EU HSC Common List

The list is currently the most authoritative list of antigen detection reagents in the EU region. The list was first published on February 17, 2021. After this update, a total of 83 covid-19 rapid antigen tests have been included in the common list, of which 35 test results have been mutually recognized by EU Member States.

IVDR CE certification

Ivdr will be enforced on May 26, 2022. Many in vitro diagnostic reagent manufacturers feel that it is still early, but vdear deeply feels that it is already late. Compared with the impact of MDR on medical device enterprises, ivdr has a greater impact on in vitro diagnostic reagent manufacturers. Why?

MDR CE certification

Is the class I (non sterile / non measuring) device still compliant after May 26, 2021 based on the "self declaration of conformity" of the MDD directive? Based on the self-compliance statement provided by the MDD directive, it will not be legally put on the EU market from May 26, 2021.

EU authorized representative

In Article 15 of the MDR, it is clearly required that the medical device manufacturer shall at least have one person responsible for regulatory compliance within its organizational structure, that is, the person responsible for regulatory compliance. The personnel shall have the necessary professional knowledge in the field of medical devices and can pass any of the following qualification certificates

UK authorized representative

To put medical devices on the UK market, manufacturers must first find a UK head (British representative). The UK head acts on behalf of manufacturers outside the UK to perform specific tasks related to the manufacturer's obligations. This includes medical devices registered with MHRA as manufacturers prior to their introduction into the UK market.

FDA certification

The products exported to the United States must be registered with the Federal Food and Drug Administration of the United States, and the action of ensuring that the products comply with the relevant American standards and health and safety requirements. Some of the products must also issue relevant tests before they can be successfully registered.

Clinical trial

In the process of clinical trial design of medical devices, the selection of evaluation indicators is related to the success or failure of a trial, which determines the height of the whole clinical research, research scalability and sample size. It is a very important factor in clinical trial design.

ISO9001 certification

SO9001 quality management system certification standard is a summary of the development of management theory and management practice in many countries, especially developed countries. It embodies a management philosophy and quality management method and mode, and has been adopted by more than 100 countries and regions in the world.

EU free sale certificate (FSC)

The content of the free sale certificate is usually to prove that the corresponding product is a legally produced and / or sold product that meets the requirements of local laws and regulations in the issuing country. At the same time, the regulatory authority of the destination country accepts the validity of the certificate issued by the issuing country to determine that it also meets the regulatory requirements of the destination country, or as one of its evidences.

Qsr820 certification

Qsr820 is the English abbreviation of American medical device quality management system regulations. It is the quality management system regulations that American (human) medical device manufacturers and foreign (human) medical device manufacturers planning to sell their products to the United States must comply with. It is the basic requirement that most medical devices must comply with before they are listed in the United States and may be spot checked at any time after they are listed.

FDA510(K) certification

510k, in essence, is a "premarket notification" (PMN) that must be done before medical products are marketed in the United States. It is a section of the act of the food, drug and cosmetics (fd&c) action committee of the United States, and the section of this act happens to be in section 510 of the fd&c act of the United States

TGA registration

In order to gain access to the Australian market, medical device and IVD manufacturers will need to include their products in the Australian therapeutic drug register (ARTG) regulated by the therapeutic drug administration (TGA). If you have obtained the European CE mark, the TGA approval process will be easier as Australia recognizes the CE mark.

Mdsap certification

The full English name of mdsap is medical device single audit program. The full Chinese name is a single audit procedure for medical devices. It is one of the coordination projects of imdrf. Imdrf (international medical device regulator Forum) is an international coordinating organization for medical device regulation established in 2012 by the medical device regulators of the United States, the European Union, Australia, Brazil, Canada and Japan on the basis of the original gthf (global medical device regulation coordination organization).

ISO13485 certification

ISO13485 medical device quality management system certification is an important basis for medical devices to meet the requirements of most national laws and regulations, and it is also the embodiment of your commitment to meet customer requirements.

Medical instrument registration certificate

Medical device registration refers to the process of systematically evaluating the safety and effectiveness of the medical devices to be marketed and used in accordance with legal procedures, so as to decide whether to agree to their sale and use.

Medical device production license

医疗器械生产许可证是医疗器械生产企业必须持有的证件,由当地药监局审核颁发。开办医疗器械生产企业应当符合国家医疗器械行业发展规划和产业政策。

Business license of medical devices

Certificates required for the operation of medical devices (instruments, equipment, instruments, materials or other articles used solely or in combination on the human body, including the required software).

Variant strain test

Ivdear is about to launch the new crown variant Omicron ba 1. Ba 2. Solutions for clinical experimental research of Xe mutant strain. The number of places is limited. Enterprises that need to carry out the experiment can make an appointment in advance.

IVDEAR (Shenzhen) Medical Technology Co., Ltd

IVDEAR (Shenzhen) Medical Technology Co., Ltd

Ivdear (Shenzhen) Medical Technology Co., Ltd., subordinate to Guorui Zhongan group, is a holding subsidiary of Guorui Zhongan group. Ivdear specializes in customized regulations and registration consulting services for medical devices and in vitro diagnostic products, and provides training services for regulations and standards. Specific service areas include: EU CE certification consulting for medical devices (IVDD, MDR, IVDR), clinical experiment, ISO13485 system certification consulting, FDA registration consulting (including 510k, QSR 820, etc.) Product inspection and rectification consultation (electromagnetic compatibility, electrical safety, performance, biocompatibility, wireless, packaging test, etc.); Domestic registered nmpa consulting services (clinical scheme cro consulting services, product registration certificate consulting services, production license consulting services, import registration consulting services).

Cooperation cases

Cooperation cases

Press Center

Press Center