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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.

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.

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Clinical experiment

Usability study

IVDD CE Certification

IVDR CE認證 Certification

Certification
Fda
MDR CE Certification

EU authorized representative

HSC common list

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Contact information

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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