Regulatory Authority: Health Products Regulatory Authority (HPRA)
The Health Products Regulatory Authority (HPRA) regulates medicines and devices for human and animal health, focusing on excellence through science, collaboration, and innovation. Their functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood components, tissues, cells, and cosmetic products.
Link for Regulatory Authority: http://www.hpra.ie/homepage/medical-devices/registration
Local Regulation: Regulation (EU) 2017/745
https://www.hpra.ie/homepage/about-us/legislation
Classification: Class I, IIa, IIb and III
Listing or Registration Requirements: Registration is mandatory for manufacturer located in Ireland.
Documents Required:
Registration Timeline: The registration process takes about 4-6 weeks after submission for
Registration Fee:
License Validity:
Special Labelling Requirements: Medical devices placed on the Ireland market must have a UKCA marking or a CE marking, depending on which legislation the device has been certified under. Where relevant, the number of the Approved Body or Notified Body must also appear on the label.
Additional Comments: If you have a registered place of business in Ireland (Manufacturers or local Authorized representatives) you must register with the HPRA if you:
are the designated European authorized representative for a manufacturer who does not have a registered place of business in the European community, and who places devices on the market within the above-listed categories.
Who should make this communication:
When to make this communication: Before placing a medical device into the market.
How OMC Medical can assist you with the process
Why Choose Us
Contact us for free consultation: [email protected]
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.