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EU Registration

EU Registration （MHRA、HPRA）

According to the EU regulations, all medical devices classified MDD: Class I, IVDD: All Classes must be registered in EU competent authorities.

And the most important, the registration must be handled by a certain legal EAR. And if the EAR located in Britain, all the products must be registered in MHRA of Britain (Medicines and Healthcare products Regulatory Agency, the British drugs and health products administration)；as well as HPRA if the EAR located in Ireland.

（MHRA、HPRA） Registration

--Basic information

--Registration contract

--Sample of registration form

--Material check

--Registration form to MHRA

--Negotiation with MHRA

--MHRA Registration certificate

Why Lotus Global?

Lotus Global，established in 2007, approved by UK government (Registration Number 6152108), focuses on European Authorized Representative Service, MHRA Registration, CFS, and  Notarization, etc. for MD/IVD manufacturer.

Lotus Global is the only one EAR who has local staffs and own offices in London, UK, Dublin, Ireland, EU, as well as back in Shanghai, China. 

Lotus Global has provided first-rate service for more than 2500 companies, including 30 public firms, such as:

Lepu Medical (Stock Code: 300003)

Andon Health (Stock Code: 002432)

Shanghai Laishi (Stock Code: 002252)

Harbin Tian Di Ren

Saint Gobain

Corporation Limited

Yonyu Plastics

Johnson Health Tech

Citic Pacific

Gardner Denver

Tosoh Silica corporation

Sirona Dental

MicroPort

Kanghui Holdings

Intai Technology Corp

KHB

Shanghai Chenguang Medical

Phonak

Bluesail…

Solemnly declare and commitment

Official allowance: Legal registered by UK and Ireland government

Qualification: Real EU official registration number and formal VAT number

Office model: Located in London, Dublin & Shanghai, single price, multiply service,

Actual location: Real effective office and Engineer-answered phone number

Extra service: CFS application for non-EU market