Market Access Solutions
UNITED KINGDOM
Non-UK Based Medical Device Manufacturers
Following the UK leaving the EU, all non-UK medical device manufacturers selling into the UK must identify / designate a Responsible Person (RP) based within the UK, to register their company and devices with the UK Competent Authority (i.e. MHRA), and to act on their behalf for UKCA related activities within the UK.
Peritus Regulatory have a UK office and are therefore able to support non-UK device manufacturers with registration with the Competent Authorities in the UK (MHRA), thus fully complying with the post-Brexit requirements.
What does an Responsible Person do for your business?
- The RP will act as a liaison between your business and the relevant competent authorities
- They will be Identified upon product labeling for the UK market
- Help with device registrations
- Provide copies of Technical Files and Declarations of Conformity to MHRA upon request
- Support with adverse incidents and Field Safety Corrective Actions working with both you and your distribution network.
Benefits of using our UK Responsible Person Service
We currently provide this service to many medical device clients globally so you can be assured of our support and expertise.
We can represent your medical or in-vitro device, evaluate Technical Files and respond directly to MHRA regarding any queries.
EUROPE
UK Based Medical Device Manufacturers
After the UK formally left the EU (BREXIT) on 31st December 2020, the UK ceased to be recognised as a full EU member state by the remaining EU members.
Therefore, to comply with the EU Directives / Regulations for CE Marking, a UK device manufacturer must designate an Authorised Representative (AR) based within a full EU member state, to register their devices with their local Competent Authority. We have an office within the EU in Cork, Ireland who can act as your AR, registering your company and devices with the Irish Competent Authority (HPRA).
Non-EU Based Medical Device Manufacturers
All non-EU medical device manufacturers must have an AR based in a full EU member state, if they also sell their devices into the EU.
Peritus Regulatory Group have a base in Ireland and therefore, are able to support non-EU device manufacturers with registration with the Competent Authorities in Ireland (HPRA), thus fully complying with the EU post-Brexit requirements.
What does an EU Authorised Representative do for your business?
- The AR will act as a liaison between your business and the relevant competent authorities
- They will be Identified upon product labelling for European market
- Help with device registrations
- Provide copies of Technical Files and Declarations of Conformity to Competent Authorities upon request
- Support with adverse incidents and Field Safety Corrective Actions working with both you and your distribution network.
Benefits of using our EU Authorised Representative service
We currently provide this service to many medical device clients globally so you can be assured of our support and expertise.
We can represent your medical or in-vitro device, evaluate Technical Files and respond directly to Competent Authorities regarding any queries.
UNITES STATES
FDA 510(k) Support
We have worked with many clients to assist them in entering the US market through the swift and cost-effective acquisition of a successful FDA 510(k) submission.
The FDA 510(k) is a notification submitted to the FDA to demonstrate your device(s) safety and efficacy.
We use a proven four-step process to ensure your successful FDA 510(k) submission:
1. Pre-submission Gap Analysis
2. Evaluation of Requirements
3. Dossier Preparation
4. Submission
FDA Quality System Regulation (QSR) 21 CFR 820 Services
If you wish to sell your medical or in-vitro diagnostic device into the US market you will first need to have a Quality Management System (QMS) (which is like the ISO13485 standard) that meets the FDA’s Quality System Regulation (QSR).
We will work with your business to provide you with a bespoke QMS which is fully complaint with the FDA QSR.
PMA Clearance
We have many years’ experience working with clients to determine the proper classification for your device in the US.
Using the FDA classification data base we can help you classify your device effectively and if this is not possible (we will assist in a novel or ‘de novo’ submission
FDA Warning Letter or Form 483 Remediation
We are able to help you in the preparation of an effective response to an FDA Warning Letter (or Form 483) including an analysis of the findings in the letter, propose suitable timeline, suggest and assist in the implementation of Corrective Actions and also we can be available to answer both the FDA’s and your queries as we work together to correct the violations or deficiencies.
CANADA
MDEL and MDL License Support
To gain access to the Canadian market you will likely need a license as issued by Health Canada. Dependent on the class of your device and route to market you will either require a Medical Device Establishment License (MDEL) or a Medical Device License (MDL).
In addition to this license you will require proof you have an ISO 13485 certified quality management system under the Medical Device Single Audit Program (MDSAP) which fulfils the criteria as specified by the Canadian Medical Device Regulation (CMDR).
ASIA
30 Years of Asian Market experience.
We have assisted many clients in successfully gaining market access to member states of the ASEAN including Malaysia and Singapore so you can have peace of mind we will be able to assist you during this process.
AUSTRALIA
TGA Compliance
Medical device regulation in Australia is managed by the Therapeutic Goods Administration (TGA) and if your device(s) are already CE certified it makes conformity to TGA requirements a more straight-forward process.
Please contact us for support and questions in this area.
Peritus offers a free initial consultation to discuss projects.