- No local presence in the UK, Australia, or New Zealand
You’re required to appoint an in-country representative — but don’t have operations on the ground. - Unfamiliar regulatory expectations
Each market has different requirements for communication, documentation, and product registration. - Regulatory authorities require a contact point
MHRA, TGA, and Medsafe expect timely, direct responses — often in the local timezone and language. - Ongoing compliance is hard to manage remotely
Without representation, updates, vigilance issues or audits become complicated and slow.
Local presence that builds global trust
Many markets require a local point of contact for foreign manufacturers. Whether you’re registering a device with the MHRA (UK), TGA (Australia), or Medsafe (New Zealand), we provide in-country representation to ensure your compliance — and peace of mind.
Your Challenges
How We Help
- Act as your official in-country representative
We serve as your legal and regulatory contact in the UK, Australia, and New Zealand. - Liaise directly with regulatory authorities
We handle communication with MHRA, TGA, and Medsafe – including submissions, updates, and clarifications. - Support product registration and documentation
We help you prepare, submit, and maintain the required information and technical files for each market. - Ensure post-market compliance
From vigilance to field safety actions, we help meet ongoing obligations in each region.
What Our In-Country Representation Covers
Local Legal Representation
Meet regulatory obligations for foreign manufacturers without setting up a local office.
Official Regulatory Contact Point
Receive and respond to inquiries from authorities like MHRA, TGA, or Medsafe.
Documentation & Registration Support
Support in submitting and maintaining device registration and declarations.
Post-Market Vigilance & Updates
Help with PMS/PMCF requirements, adverse event reporting, and regulatory updates.
Timely Response in Local Time Zones
Ensure smooth communication with regulators across UK and APAC.
Integration With Your Regulatory Team
We collaborate directly with your RA/QA team or consultants to streamline workflows.
