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Service Items
SRN registration
The full English name of SRN is single registration number, which refers to the unique identification of each economic operator on the EU medical device database eudamed and relevant official documents and reports. Generally speaking, SRN is the unique ID number of the manufacturer or importer in the eudamed system, which can realize various identification and traceability effects.
Variant strain test
Grzan medical 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.
Cmdcas certification
Canada implements the quality system review of government registration combined with the third party. The third party mentioned here refers to the third party organizations recognized by the Canadian Standards Committee (SCC) that can conduct the audit of the Canadian medical devices conformity assessment system (cmdcas), such as TUV PS, BSI, and other certification companies, hereinafter referred to as the cmdcas accreditation bodies.
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.
CSDT注冊(cè)
ASEAN CSDT recommended the format of ASEAN CSDT in Annex 4 of the Southeast Asian Medical Device Directive (AMDD), which was signed by ten countries in Southeast Asia: the Philippines, Malaysia, Singapore, Thailand, Brunei, Vietnam, Myanmar, Laos, Cambodia and Timor Leste.
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.
CTDA registration
Coronavirus test device approvals, or CTDA for short, is a regulation issued by the British government for the new crown test reagent, which was implemented in July 2021. From November 1, 2021, the new crown detection IVD products that have not applied for and / or passed the CTDA review will not be legally sold in the UK market.
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).
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.
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.
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.
Mdel registration
Manufacturers of class I medical devices and in vitro diagnostic equipment must obtain a medical device enterprise license (mdel) if they sell the equipment directly to Canada instead of through distributors. However, if it is sold to Canada through a distributor, your distributor must obtain mdel. Distributors and importers of medical devices and in vitro diagnostic equipment, regardless of the classification of medical devices, must obtain mdel.
Medical device production license
The medical device production license is a certificate that medical device manufacturing enterprises must hold, issued after review by the local drug administration. Establishing a medical device manufacturing enterprise should comply with the national medical device industry development plan and industrial policies.
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).
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
Preparation of ukca technical documents
The UK local authorized representative must keep the documents proving that the product meets the regulatory requirements. After the product is put on the market, the documents must be kept for 10 years. Market surveillance or law enforcement agencies can request such information at any time to check whether your products comply with legal requirements.
UKCA認(rèn)證
UKCA（英國符合性評(píng)估）標(biāo)志是新的英國產(chǎn)品標(biāo)志。 如果英國“無協(xié)議”脫歐，經(jīng)議會(huì)批準(zhǔn)將對(duì)投放到英國市場(chǎng)上的特定產(chǎn)品使用該標(biāo)志。?
MHRA registration
MHRA is the abbreviation of the British drug regulatory agency, and its full name is medicines and health products Regulatory agency MHRA is an executive government agency subordinate to the British Ministry of health, which ensures the safety and effectiveness of drugs and medical devices.
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.
Preparation of MDR CE technical documents
If the CE certificate conforming to the MDD standard expires during the transition period, and the CE certificate conforming to the MDR standard is not obtained during the transition period, your product must exit the EU market, and can be re launched only after the product has obtained the CE certificate conforming to the MDR standard.
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,
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.
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.
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.
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.
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?
IVDD CE certification
Any medical device, including reagents, reagent products, calibration materials, control materials, kits, instruments, devices, equipment or systems, intended by the manufacturer for in vitro examination of samples obtained from human body, including blood and tissue donors, whether used alone or in combination,
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
Grzan medical technology (SZ) Co., Ltd
Grzan medical technology (SZ) Co., Ltd subordinate to Grzan group, is a holding subsidiary of Grzan group. Grzan medical 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).
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Tel：0755-33509057
Adress：Room 103-108, Building B, Block 2, Bangkai Science and Technology Park, No. 9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
E-mail：hitolin@grzan.com
Grzan medical can undertake the whole process of technical guidance and services such as prospective clinical, who Eul, variant virus research (Delta, Omicron ba.1, ba.2), IVDD CE, ivdr CE, Australian TGA, British CTDA, European HSC common list, European service, British service, etc.
If you have products that have been tested and certified or want to know more about them, please contact Grzan medical！
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