1. Certification Overview
The Medical Device Authority (MDA) is a federal statutory body under the Ministry of Health of Malaysia that implements and enforces the Medical Devices Act (Act 737).
All facilities intending to launch medical devices in the Malaysian market must hold an Establishment License in accordance with Act 737. Accordingly, in the case of imported medical devices, the manufacturer must obtain an Establishment License by designating a local company or business operator (authorized representative) residing in Malaysia.
In Malaysia, medical devices refer to all products used in the medical field for the diagnosis, prevention, monitoring, or treatment of diseases or disorders, excluding pharmaceuticals. Medical devices are classified into four classes—A (low risk) to D (high risk)—based on their risk level, and the criteria for determining these classes are provided in MDA/GD-04.
Medical device registration is done through the online Medical Device Centralized Online Application System (MeDC@St), and applicants must create a MeDC@St account before applying.
2. Regulatory Bodies & Basic Information
| Regulatory Agencies | MDA (Medical Device Authority) |
| Certification Body | 1. BSI SERVICES MALAYSIA SDN. BHD 2. TÜV RHEINLAND MALAYSIA SDN. BHD 3. SGS MALAYSIA SDN. BHD |
| Lead time / Price | Varies by product |
| Agent | Local agent required |
3. Medical Device Classification
| Class | Risk | Example | |
|---|---|---|---|
| Class A | Low risk | • Basic Examination & Surgical Tools: Tongue depressors, Surgical retractors, Mechanical stethoscopes • Hospital Furniture & Mobility Aids: Hospital beds, Manual wheelchairs, Crutches • Non-sterile Surgical Wear & Dressings: Surgical gloves, Non-sterile bandages, Medical face masks |  Medical face masks |
| Class B | Low to Moderate risk – CAB review subject | • Electronic Monitoring & Measuring Devices: Electronic blood pressure monitors, Digital thermometers, Hearing aids • Hypodermic & Suction Consumables: Hypodermic needles & syringes, Suction equipment, Oxygen masks • [가정용 미용 기술군] Home-use Aesthetic Devices: Low-power LED masks, Galvanic/Microcurrent skin care tools |  Hypodermic needles & syringes |
| Class C | Moderate to High risk – CAB review subject | • Active Life-Support & Imaging Systems: Lung ventilators, Infusion pumps, Dialysis machines, Ultrasound imaging systems • Short-to-Medium Term Surgical Implants: Orthopedic bone plates & screws, Bone grafts • Clinical Aesthetic Equipment & Materials: Clinical High-intensity focused ultrasound/HIFU, Contact lenses, Blood bags |  Ultrasound imaging systems |
| Class D | High risk – CAB review subject | • Central Circulatory & Life-Sustaining Implants: Coronary/Vascular stents, Implantable pacemakers, Artificial heart valves • Neurological & High-Risk Invasive Devices: Implantable neurostimulators, Cochlear implants • Injectable Materials & Deep Tissues Materials: Hyaluronic acid dermal fillers, Absorbable surgical sutures, Breast implants |  Absorbable surgical sutures |
4. Certification Process
- Appointment of a local agent in Malaysia and acquisition of incorporation license
- Medical Device Classification Verification and Medical Device Grouping
- A certificate is issued by an accredited Conformity Assessment Body (CAB) after reviewing technical documents according to the Common Submission Dossier Template (CDST).
- Preparation of documents required for registration: CSDT, CSDT supporting documents, DoC documents, etc.
- Send all materials to MeDC@St through the Malaysian agent
- Issuance of a certificate containing the registration number after MDA evaluation and approval
5. Required Documents
| Administrative & Legal Documents | • Letter of Authorization (LOA) • Application Form via MeDC@St • Conformity Assessment Certificate from a Third-Party Certification Body • Pre-Market Clearance / Reference Country Approval |
| Quality Management System Documents | • Quality Management System Certification (QMS / ISO 13485 Certification) • Production Flow Chart |
| Technical & Safety Dossier | • ASEAN Common Submission Dossier Template (CSDT) • Essential Principles Checklist & DoC • Risk Management Report • Verification & Validation Test Reports • Clinical Evidence & Post-Market Vigilance History • English Labeling & Instructions for Use (IFU) |
6. Validity Period and Maintenance
- Validity Period: 5 years
- Renewal: Apply for re-registration through the online system 6 to 12 months before expiration.