- Medical
- Regulatory
Medical device registration consultant in Malaysia for MDA product registration
Medical device product registration support in Malaysia. Classify your devices, prepare your CSDT and get ready for MDA registration under Act 737.
4.9 / 5 from 1,000+ Google reviews- 4,000+cases and clientscases and clients supported
- 17+ yearsexperienceconsultancy experience
- Class A–Dmedical devicesmedical devices
- Act 737Medical Device ActMedical Device Act 2012
Service overview
About Medical Device Product Registration
Under the Medical Device Act 2012 (Act 737), a medical device must be registered before it can be imported, exported or placed on the market in Malaysia. Applications go to the Medical Device Authority (MDA) through its MeDC@St online system, from the manufacturer or, for a manufacturer based outside Malaysia, its appointed authorised representative.
What each application needs depends on the device’s risk class, from Class A (lowest risk) to Class D (highest risk). Class B, C and D devices generally need a conformity assessment by an MDA-registered Conformity Assessment Body before registration, supported by technical documentation in the Common Submission Dossier Template (CSDT) format. We help you work out what applies to your devices and prepare it properly.
Business value
Key benefits
- Place medical devices on the Malaysian market lawfully.
- Confirm each device's risk class and how to group your products.
- Submit a complete, well-organised technical dossier.
- Respond to MDA queries with clear supporting evidence.
Who needs this?
Medical device manufacturers in Malaysia, and authorised representatives of foreign manufacturers.
Certification, training and compliance requirements vary by tender, buyer and regulator. We confirm what applies to you during the free consultation.
How we support you
A clear path from questions to readiness
Classify your devices
Each device’s risk class confirmed, products grouped and your role as manufacturer or authorised representative made clear.
Prepare the technical file
Your documentation reviewed and organised into the CSDT format, with gaps identified and addressed.
Coordinate conformity assessment
For Class B, C and D devices, support through assessment by an MDA-registered Conformity Assessment Body.
Apply and follow up
Your MeDC@St application prepared, with support answering queries during the MDA’s evaluation.
How we work with you
The right consultant for your medical device registration project
We match every project to an experienced consultant who knows your industry, and the same consultant stays with you through to your MDA application.
- Matched to your devicesWe pair you with a consultant who understands medical devices and the requirements for their risk class.
- Experienced with the processYour consultant knows what a complete dossier needs and prepares your team for questions from the MDA.
- One consultant, start to finishThe same person handles your classification, documentation and application.
“DR ISO audit was a great experience. The audit team was professional, supportive, and highly skilled. Their structured approach, clear explanations, and constructive recommendations helped us validate our processes and identify meaningful opportunities for improvement”
Common questions
Before you enquire
How long does Medical Device Product Registration take?
It depends on the device’s risk class, how complete your documentation is, and the conformity assessment and MDA evaluation. After reviewing your devices we give you a realistic timeline.
What support is included for Medical Device Product Registration?
The main focus areas are device classification and grouping, Common Submission Dossier Template (CSDT) preparation, conformity assessment coordination for Class B, C and D devices, MeDC@St application preparation and responses to MDA queries and registration upkeep. Support is tailored to your devices and where your documentation stands today.
Who can apply to register a medical device in Malaysia?
The manufacturer or, for a manufacturer based outside Malaysia, its appointed authorised representative. The application is made through the MDA’s MeDC@St online system.
Is product registration the same as an establishment licence?
No. Registration applies to the device, while the establishment licence applies to the company that manufactures, imports or distributes it. Most companies need both, and we can support you with GDPMD or ISO 13485 for the licence.
Explore further
Often combined with medical device registration
Get clear guidance on your Medical Device Product Registration scope.
Book a free consultation or WhatsApp us. We reply within 24 hours.