Malaysia Medical Device Registration

Malaysia Medical Device Registration (MDA Registration Overview)

1. Regulatory Authority & Framework

Malaysia regulates medical devices under the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012.
Oversight agency: MDA – Medical Device Authority, Ministry of Health.
Digital submission platform: MeDCaSt (Medical Device Centralised Online Application System).

Manufacturers, importers and distributors must comply with:

• Device registration
• Establishment licensing (manufacturer, importer, distributor)
• Post-market obligations (vigilance, reporting, conformity to standards)

2. Classification Rules

Malaysia follows a GHTF / ASEAN-aligned 4-class system:

Classification is based on intended use, duration of contact, invasiveness, and whether the device is active.

3. Registration Pathway & Requirements

Registration requires Conformity Assessment (CAB audit) + MDA submission.

Step 1 – Appoint Local Authorized Representative (AR)

Foreign manufacturers must appoint a Local Authorized Representative (AR) in Malaysia responsible for:

• Compliance & communication with MDA
• Product registration & vigilance
• Post-market corrective actions

Step 2 – Conformity Assessment (CAB)

A CAB (Conformity Assessment Body) performs assessment depending on class:

• Class A: Self-declaration
• Class B, C, D: CAB review of QMS + technical documentation
• CAB issues:
  • Certificate of Conformity (CoC) or
  • ISO 13485 audit reports + technical review approval

Step 3 – MDA Registration (MeDCaSt)

Submission includes:

• Device description & intended use
• Classification rationale
• Evidence of safety & performance
• Essential Principles checklist (ASEAN Common Submission Dossier Template — CSDT)
• QMS evidence (ISO13485 for Class B–D)
• CAB certificate (CoC/API)
• Labeling & IFU compliant with Malaysia requirements
• Clinical evidence (if applicable to device risk category)

Approval output: MDA Registration Certificate (valid for 5 years).

4. Dossier Format (CSDT Structure)

Malaysia adopts ASEAN CSDT, including:

• Executive summary
• Device description
• Design verification & validation
• Clinical evidence
• Risk analysis (ISO 14971)
• Manufacturing information
• QMS certification
• Labeling (BNM/Malay language requirements)
• Post-market surveillance plan

5. Fees & Timelines (Typical)

Official MDA Fees (approx.)

• Class A: ~MYR 500–800
• Class B: ~MYR 1,000–2,000
• Class C: ~MYR 2,000–3,000
• Class D: ~MYR 3,000–4,000

CAB Assessment Fees

Depend on CAB & class (Class B–D significant variation).

Timelines

• Class A: 1–2 months
• Class B: 4–6 months
• Class C/D: 6–9+ months (depending on CAB audit & data completeness)

6. Labeling Compliance (Key Requirements)

Labels must include:

• Device name, model
• Manufacturer & AR details
• Lot / serial number
• Manufacturing & expiry date (if applicable)
• Storage conditions
• Malay language requirement for key safety information
• IFU (electronic IFU acceptable for certain device types)

7. Post-Market Obligations

• Mandatory problem/incident reporting
• Field safety corrective action (FSCA)
• Device listing updates & renewals
• QMS maintenance
• Distribution record-keeping
• Periodic compliance monitoring by MDA

8. Special Notes for Your Projects (Consulting Perspective)

Given your portfolio (soft hydrophilic contact lenses, robots, HF surgical equipment, blood glucose meters, single-use kits, etc.):