Markets
Which market first is a regulatory decision, not a sales one.
Three market guides are live, each with the regulator, the route, the representative a non-resident manufacturer must appoint, and the dated changes you need to know about. The order in which you enter markets decides how much evidence you generate once and how much you repeat.
| Market | Regulator | Route to market | Representative for non-resident manufacturers | Guide |
|---|---|---|---|---|
| United States | FDA CDRH | 510(k), De Novo or PMA by classification; exempt Class I and some Class II | US Agent; initial importer | Live |
| European Union | National competent authorities; notified bodies; European Commission | CE marking under the MDR or IVDR by class; notified-body assessment for all but the lowest classes | Authorised Representative (MDR Art. 11); PRRC (Art. 15) | Live |
| India | CDSCO; State Licensing Authorities | Licence or registration under the Medical Devices Rules 2017 by risk class A to D; import licence held by an Indian Authorised Agent | Authorised Agent (holds the import licence) | Live |
| United Kingdom | MHRA | CE recognition continues in Great Britain; UKCA is the domestic route; pre-market regulations in draft | UK Responsible Person | In preparation |
| Singapore | HSA | Registration by risk class under the Health Products Act; abridged routes for devices with reference-agency approvals | Local registrant | In preparation |
| Australia | TGA | ARTG inclusion by class; comparable overseas regulator evidence accepted | Australian Sponsor | Phase C |
| Canada | Health Canada | Medical Device Licence by class; MDSAP certificate required for Class II–IV | Importer or MDEL holder | Phase C |
| ASEAN | National authorities (MDA, HSA, Thai FDA and others) | CSDT-based submissions under the ASEAN Medical Device Directive | Local licence holder | Phase C |
Sequencing markets
The same biological evaluation, the same risk file and much of the same technical documentation serve the EU, the US and India, provided they are built to the most demanding of the three from the start and the differences are handled as deltas rather than as separate files. A manufacturer who builds an MDR-grade file and then adds the FDA-specific records and the CDSCO forms spends far less than one who builds three files in sequence.
Where to start depends on where the evidence is strongest, where the commercial pull is, and which regulator's decision the others will accept. An FDA clearance helps a Singapore or Australian submission; a CE certificate helps almost everywhere; neither replaces the Indian import licence. The scoping call exists to put these in order for your device.
Representation is not interchangeable
Every market in the table requires a non-resident manufacturer to appoint someone in-country, and the roles are different in law. A US Agent handles FDA correspondence and has no product-liability role. An EU Authorised Representative has statutory obligations under MDR Article 11 and can be held liable alongside the manufacturer. An Indian Authorised Agent holds the import licence in its own name. Authentcare coordinates these appointments and helps you meet their requirements; it does not act as any of them.
Which market first is a regulatory decision.
Sequencing markets well reuses evidence; sequencing them badly repeats it. Thirty minutes is enough to see the order.