Medical Devices
Every market has its own rules for medical devices, but most are built on the same international foundations - risk-based classification, a quality management system, and a local representative to hold your registration.
At Taylored Consultancy Ltd, we help you build a single, robust regulatory and quality foundation that travels. We make the most of international harmonisation (IMDRF) and reliance routes so your CE or FDA approvals can open doors in other markets - then we advise you closely on the specifics of each country you're targeting.
Clearing the path to market -
regulatory and quality expertise that gets your medical devices market-ready, compliant, and trusted - wherever you launch.
We help you plan a route to market across multiple countries, prioritising the approvals and evidence that unlock the most markets.
Many markets accept CE marking or FDA clearance through reliance routes. We help you leverage existing approvals to enter new regions faster.
We determine how your device is likely to be classified across target markets using internationally harmonised (IMDRF) principles.
We build technical documentation to international standards so it can be adapted efficiently for each market, rather than rebuilt from scratch.
We help develop and implement a QMS to ISO 13485 - the universal baseline accepted around the world - and ISO 9001.
Almost every market requires an in-country representative or licence holder. We help you understand and arrange the right local representation for each region.
Wherever you're heading, we identify what's missing and support you through audits and inspections.
Every market has its own rules, and the detail matters. Get in touch for a free consultation and we'll map out exactly what your product needs, wherever you're headed.
ISO 13485 - Medical devices
ISO 9001 - General
ISO 14971 - Risk management for medical devices
ISO 10993 - Biocompatibility
IEC 60601 - Electrical safety and electromagnetic compatibility for medical devices
ISO 11135 - Ethylene oxide sterilisation of medical devices
ISO 11607 - Packaging for terminally sterilised medical devices
ISO 15378 - Primary packaging materials for medicinal products
ISO 14155 - Clinical investigation conduct
EN 62304 - Software within a medical device
IEC 61326 - EMC requirements for electrical equipment
ISO 15197 - Blood glucose monitoring systems
2014/53/EU - Radio Equipment Directive (Bluetooth / Wi-Fi)
FCC - Federal Communications Commission requirements for Bluetooth / Wi-Fi
MDSAP - Medical Device Single Audit Programme
IMDRF guidance - International harmonisation
Often, yes. Many regulators, including Australia's TGA, recognise CE marking or FDA clearance as strong supporting evidence through reliance and recognition pathways, which can cut down on duplicated testing and documentation when you expand into a new market. It's not a blanket pass everywhere though, so which elements of your existing technical file actually transfer depends on the specific country and device class.
IMDRF is the International Medical Device Regulators Forum, a group of major regulators working to harmonise definitions, classification principles and quality expectations across countries so manufacturers aren't reinventing their approach for every market. It matters because a device built to IMDRF-aligned principles from the start travels more easily between regions, rather than needing a ground-up rework every time you enter a new country.
There's no single right order. It depends on your device's risk class, where your strongest existing approval or clinical evidence sits, and which markets matter most commercially, but sequencing around reliance pathways generally saves time and cost. Securing a strong CE marking or FDA clearance first, then leveraging it into markets like Australia that recognise those approvals, is often more efficient than pursuing every region from a standing start.
In most cases, yes. The UK, EU, Australia and several other markets all require a locally based representative (a Responsible Person, Authorised Representative or Sponsor, depending on the country) if you don't have your own entity there, and you generally can't register your device without one in place. Requirements and terminology differ by country, so it's worth mapping out who you need where before you commit to a launch timeline.
MDSAP is the Medical Device Single Audit Programme, which lets a single quality management system audit satisfy the requirements of several participating regulators, including in Australia, the US, Canada, Brazil and Japan, instead of facing a separate audit for each one. For manufacturers targeting multiple MDSAP markets, it can genuinely cut down on audit fatigue and cost, though it's worth checking it actually covers every market on your list.
The key is building one robust regulatory and quality foundation. That means a strong ISO 13485 QMS, classification done to IMDRF principles, and technical documentation written to a common standard, which then gets adapted for each market rather than rebuilt from scratch every time. We help manufacturers plan that sequencing so each new market approval builds on the last instead of duplicating work, which is where the real time and cost savings come from.
Not always from scratch. Testing such as biocompatibility and performance testing, along with your clinical evaluation, is often reusable across markets provided the device, its intended use and manufacturing stay the same, and reliance pathways let some regulators lean on an existing CE mark or FDA clearance rather than demanding fresh evidence. What does still need addressing per market is local technical documentation, registration and, in some cases, additional evidence to satisfy a specific regulator's requirements. We review what you already have before recommending any new testing.
Still have questions? Contact us and we'll be happy to help.
