Medical Device Authority (MDA) Registration
MDARegistration coordination and local Authorized Representative support for eligible medical-device projects.
- Lead Time
- Estimated after technical review — depends on product category, test readiness and authority workload
- Certificate Validity
- Scheme-specific — confirmed during scope review
- Local Rep Required
- Confirmed during scope review
Overview
The Medical Device Authority (MDA) is Malaysia’s regulatory body for medical devices, established under the Medical Device Act 2012 (Act 737). All medical devices — from Class A (lowest risk, e.g. bandages) to Class D (highest risk, e.g. implantable cardiac devices) — must be registered in the Malaysian Medical Device Register (MeDC@St) before they may be placed on the market.
Foreign manufacturers are required to appoint a Malaysian Authorised Representative (MAR), who assumes regulatory responsibility for the device in Malaysia. AECS provides MAR services and manages the full submission lifecycle on behalf of the manufacturer.
What AECS does
- Device classification review
- Malaysian Authorised Representative (MAR) service
- Conformity assessment file review (QMS, technical documentation)
- MeDC@St registration application and query management
- Registration renewal and change notification handling
- Post-market surveillance support
What Clients Send Us
For the fastest assessment, provide:
Product name, model and intended use
Datasheet / technical specification
Complete RF technology and frequency-band list
Existing RF / EMC / Safety / SAR / EMF reports
Module approvals and antenna specifications
User manual, product photos and label artwork
Target countries and desired launch timing
Importer / distributor details where already appointed
Ready to get started?
Contact Nash to discuss your Medical Device Authority (MDA) Registration requirements.