Medical device registration consultants for market access in Saudi Arabia, the UAE, India, Australia and Canada.

What it is

What is medical device registration and what is it used for?

Medical device registration is the permission a national authority gives before a device can be imported, supplied or sold in its territory. The name changes from country to country. The Saudi Food and Drug Authority (SFDA) issues a Medical Device Marketing Authorisation, known as MDMA. In the UAE, the Emirates Drug Establishment (EDE) lists the issuance and renewal of a marketing authorisation for a medical device among its services, and the Ministry of Health and Prevention (MOHAP) has announced the transfer of selected services to EDE. India's Central Drugs Standard Control Organization (CDSCO) licenses imports under the Medical Devices Rules, 2017. Australia's Therapeutic Goods Administration (TGA) includes devices in the ARTG. Health Canada grants medical device licences under the Medical Devices Regulations.

Behind the different forms sit two questions: is the device safe and does it perform as claimed, and is it made under a quality system that keeps it so?

How the route works. There is no registration certificate from a consultant or a certification body. Each authority reviews the application made by the manufacturer or its local party and decides. ISO 13485:2016 is the quality system standard these files usually lean on, and the Medical Device Single Audit Program (MDSAP), based on ISO 13485, is recognised by both TGA and Health Canada. ISO 13485 certification: the hub

Who it is for

Who needs medical device registration support?

Any company selling a device in these markets needs the authorisation, whether it makes the device, has it made under contract or sells it under its own brand. Companies come to Sterling from four starting points:

• A distributor or hospital buyer wants the product. An importer is ready to order, but nothing ships until the authorisation is in place.
• A tender asks for proof of registration. Public procurement often expects the device to be authorised before the bid closes, so the evidence must be ready months ahead.
• An authority has asked questions. A deficiency letter or a request for more information exposes gaps in risk management, testing or quality system records, and the answer has a deadline.
• A group company is adding markets. One plant, several countries and several local partners, each asking for different documents. One consistent technical file saves doing the work five times.

Registration opens a market; it does not replace post-market duties. The authorisation stays valid only while the device, the file and the quality system stay under control.

Requirements

What are the main medical device registration requirements?

Each authority publishes its own rules, forms and guidance, and the detail depends on the device and its classification. At title level, these are the routes and obligations a manufacturer plans for. Device classes, fees and review times come from each authority's own current guidance and are confirmed for your device during the gap analysis.

• Saudi Arabia, SFDA: a Medical Device Marketing Authorisation (MDMA) through SFDA's online system, with separate SFDA rules for licensing device establishments and authorised representatives, and SFDA guidance on ISO 13485 requirements.
• United Arab Emirates, EDE: issuance and renewal of a marketing authorisation for a medical device, and registration of the manufacturer of medical products.
• India, CDSCO: an import licence for the device under the Medical Devices Rules, 2017, supported by the checklist CDSCO publishes for the application.
• Australia, TGA: inclusion in the ARTG through an Australian sponsor, backed by manufacturer evidence such as TGA conformity assessment certification or evidence from comparable overseas regulators.
• Canada, Health Canada: a medical device licence under the Medical Devices Regulations (SOR/98-282), MDSAP evidence for manufacturers of class II, III and IV devices, and a separate route for medical device establishment licences (MDEL).
• Quality system evidence: a device quality management system to ISO 13485:2016, and an MDSAP audit where a market relies on it.
• After authorisation: renewals, notification of changes and post-market responsibilities as each authority defines them.

Registration process

How do you register a medical device in these markets?

First make the device file and the quality system ready for review. Then the local party submits to each authority. Sterling prepares and checks the evidence with your team; the filing is made by you or your local representative, and the decision belongs to the authority.

1. 01
   Confirm markets, devices and who will hold the authorisation.List the products and target countries, the likely classification in each and the local representative, sponsor or importer who will apply.
2. 02
   Gap analysis: compare your file with each authority's list.Technical documentation, risk management, clinical evidence, labelling and quality system records are checked against current guidance, and actions are agreed with owners and dates.
3. 03
   Build the technical and quality evidence.Close the documentation gaps, bring the ISO 13485 system to audit standard and prepare for MDSAP where Australia or Canada is in scope.
4. 04
   Review the dossier with your local representative.Each market version is checked for consistency before the representative files it; questions from the authority are answered with your engineers, on evidence.
5. 05
   Keep every authorisation current.Renewals, design and supplier changes, complaints and post-market reporting are tracked so the file still matches the device on the market.

Check the route before you sign. Confirm who will hold each authorisation and that your local representative is licensed where the authority licenses them, as SFDA does. Verify results on the authority's own channels: Health Canada lists active licences in MDALL, and TGA keeps the ARTG. Be wary of anyone who promises an approval date or says they will register the device for you without a device file. How to choose a regulatory partner

Cost

How much does medical device registration support cost?

One low-risk device for one market is a different project from a family of implants for five. The proposal shows every component, with the consulting fee fixed.

Timeline

How long does medical device registration take?

Two clocks run. The first is yours: how long it takes to complete the technical file and bring the quality system to audit standard. The second belongs to each authority and its review queue, which no consultant controls. As an estimate, a programme from gap analysis to authorisation typically takes 3 to 12 months, depending on the markets, the device class and the evidence already in hand.

Share any tender or launch date on day one. We will say which market can realistically come first and which evidence decides it.

Your engagement

What your medical device registration engagement includes

Sterling works on the evidence: the technical documentation and the ISO 13485 quality system that every one of these applications draws on. Sterling does not register, certify or approve anything; your local representative files, and each authority decides.

• Market scope and gap analysis

  Devices, countries and representatives mapped, with actions, owners and dates.

• Technical documentation

  One master file, with market versions prepared from it for your representative to file.

• ISO 13485 and MDSAP readiness

  A device QMS built to audit standard where one is missing or weak.

• Effivity ISO & GRC software

  Files, changes and complaints in one workspace, included with the engagement at no additional cost.

• Training for your team

  Internal auditor training, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.

• Support through authority questions

  Answers prepared with your engineers until each authority decides.

Sterling OS™ sets the level of support. With Design™, our consultants guide and your team does the drafting; with Drive™, we take on the drafting and your team reviews and approves. Choose one or the other for the engagement. After authorisation, Sustain™ keeps files, renewals and the quality system current, and Automate™ runs it all in Effivity.

Authorisation decisions remain with each national authority.

Often combined with

Standards organisations pair with Regulatory registration

• 21 CFR Part 11 / EU Annex 1121 CFR Part 11 and Annex 11 compliance for GxP systems: requirements, validation, audit trails and e-signatures, with evidence ready for FDA and EU inspectors.
• ADHICS (Abu Dhabi)ADHICS compliance consulting for DoH-regulated healthcare entities in Abu Dhabi: patient information, systems and devices protected, with audit-ready evidence.
• CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
• EU IVDR 2017/746EU IVDR compliance consulting for IVD manufacturers: performance evidence, QMS, traceability and post-market follow-up prepared for your notified body.
• EU MDR 2017/745EU MDR compliance consulting for CE marking: QMS, technical documentation, traceability and post-market surveillance prepared for your notified body.
• FDA QMSR (21 CFR 820)FDA QMSR compliance consulting for device makers selling in the US: a quality management system ready for FDA inspection, wherever you manufacture.