Is Your Product a Medical Device?

Use the steps below to determine whether your product is regulated as a medical device under Act 737 and therefore requires establishment licensing and device registration.

Step 1 — Check the Intended Purpose

Does the product have a medical intended purpose as defined in Act 737? Medical purposes include: diagnosis, prevention, monitoring, treatment or alleviation of disease; compensation for injury; support of anatomy/physiological process; sustaining life; contraception; disinfection of a medical device; providing diagnostic information from in vitro examination.

➡️ YES → Proceed to Step 2
➡️ NO → Product is likely not a medical device under Act 737

Step 2 — Check the Mode of Action

Does the product achieve its primary intended effect through pharmacological, immunological, or metabolic means?

➡️ YES → Likely a pharmaceutical product — regulated by NPRA, not MDA
➡️ NO / ASSISTED → Proceed to Step 3

Step 3 — Check for Exclusions

Product Type	Regulator
Prescription and OTC drugs	NPRA
Cosmetics	MOH (Cosmetics regulations)
Food products / supplements	MOH (Food Safety)
Veterinary devices	Department of Veterinary Services

➡️ Excluded → Not within MDA scope
➡️ Not excluded → Product is a medical device

Step 4 — Determine Registration Requirement

Scenario	Requirement
Commercially supplied in Malaysia	Registration required
Custom-made for individual patient	Exempt from registration
Urgent/humanitarian need	Special Access Route
Device in transit	Exempt

Quick Reference Checklist

Question	Yes	No
Medical purpose?	→ Continue	→ Likely not a device
Achieves effect physically/mechanically?	→ Continue	→ May be a drug
Commercial supply in Malaysia?	→ Registration needed	→ Check exemption
Manufactured, imported, or distributed commercially?	→ Establishment licence needed	→ Check exemption

MDA Clarification Request

If uncertain, submit a product classification enquiry via the MyMDA portal. MDA will provide a formal determination.