What is the UK MHRA certification of electronic cigarettes? MHRA Regulatory Requirements

In accordance with the Brexit Agreement, the UK will no longer recognize the EU CE certification. The electronic atomizer (electronic cigarette) needs to be registered and certified separately by MHRA when entering the UK market.

"On October 29, 2021, the UK Medicines and Health Products Administration (MHRA) updated its earlier" Guidelines for the Licensing of Electronic Cigarettes and Other Inhaled Nicotine containing Products (NCP) as Drugs "on its official government website, which means that the UK may be the first country in the world to implement medical product licensing for medical electronic cigarettes.

What is the MHRA registration certification?

The full English name of MHRA is "Medicines and Healthcare products Regulatory Agency".

Since January 1, 2021, many changes have taken place in the way medical devices are sold in the UK market, including the new conformity assessment route for the UKCA logo. Before June 30, 2023, the British market will still accept medical devices with CE mark, while the Northern Ireland market will accept medical devices with CE mark indefinitely.

"Any medical devices sold in the UK market need to be registered with MHRA, and non UK manufacturers need to appoint a person in charge in the UK."


MHRA Regulatory Requirements:

● The oil storage bin capacity of electronic smoke shall not exceed 2ml.

● The capacity of refilling bottle containing nicotine oil shall not exceed 10ml.

● Nicotine concentration in tobacco oil shall not exceed 20mg/ml.

● Nicotine containing products and their packaging shall be able to prevent children from opening and tampering.

● Colorants, caffeine and taurine are prohibited.

● Products put into GB (Great Britain) must contain new labels and warnings.

● Before the product is put on the GB market, it must be notified to the Pharmaceutical and Health Products Regulatory Authority (MHRA) in advance.