UKCA Marking Guidance :
This is a quality assurance test performed by an independent body to ensure that a medical device complies with relevant European Union regulations. A notified body is a company or organization which has been designated by the European Commission to perform such tests. The purpose of the test is to verify whether the product meets the requirements set out in the legislation.
Importance of UKCA :
– The United Kingdom Conformity Assessment (UKCA Marking) is the UK equivalent to the EU CE Marking
– The UKCA Marking is a valid indicator that the product conforms to relevant UK regulations & lt
– The UKCA is a mandatory requirement for medical devices sold in the UK post Brexit
– Manufacturers or their authorised representatives are responsible for affixing this mark to the product
– The UKCA mark can only be used on products manufactured in the UK&
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UKRP – UK Responsible Person :
In order to legally sell medical devices in the UK, a manufacturer must designate a UKRP. The UKRP has been appointed by the Overseas Manufacturer to act as their representative in the UK. The UKRP will then be responsible for ensuring that the product complies with all applicable requirements.
We provide UK RP Services to assist companies who wish to register their products as Medical Devices in the UK. The UKRP service provides advice and guidance on how to comply with the requirements of the MDR Directive. It also covers the obligations of the company to ensure compliance with the MDR Regulation and any relevant national legislation.
Free sale certificate ( UK) :
The free sale certificate can be issued for medical devices and IVD’s that have been registered with The Medicines and Healthcare Products Regulatory Agency (MHRA). This means that your device has been assessed as safe and effective for its intended purpose, and it meets the requirements set out in the EU Medical Devices Regulation (EU) 2017/745.
The free sales certificate is requested by an authorized representative of a manufacturer who is not located in the United Kingdom.
Here are we to help you to get the Free sale certificate. Contact us today for more details!
EU CE - Marking
Medical device manufacturers without a physical presence in Europe are required to appoint a European Authorised Representative. For EU MDR & IVDR Medical Device CE Marking, an EU Representative is required. EC Rep can be used on any type of medical device.
On device information panels, the name and contact details of the EU Representative must be visible. A European Representative should be selected based on their knowledge and experience with medical device regulations and related regulatory requirements.
USA FDA Registration
As per FDA Regulation, MANUFACTURES, INITIAL EXPORTERS, and INITIAL IMPORTERS must complete FDA certification for medical devices.
- Check the device Product code and Regulation number
- Check for 510k exemption
- Appoint US FDA Agent (Only for Foreign Manufactures)
- Fill and submit the Establishment Registration application form with US Agent appointment Authorization
- Facility Name/address information
- Device Class and code
- Make a US Agent annual payment.
- Create an Account with FDA
- Make a payment at the Device Facility User Fee (DFUF) website and get Payment Identification Number (PIN)
- Update Registration and Listing System (FURLS) account for the owner or the operator.
- Verify registration and Listing information on the FDA website