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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.
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)議會批準(zhǔn)將對投放到英國市場上的特定產(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.

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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.

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