MDA/GD/0063 · Act 737 s.2 · ASEAN Medical Device Committee
Borderline products: is yours a medical device?
A skin laser can be a device or a beauty appliance. An eye drop can be a device or a medicine. In Malaysia the answer depends mainly on what the manufacturer claims, and MDA publishes a list of decisions you can check first.
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Short answer: a borderline product is one that is hard to distinguish from a medical device, such as a possible medicine, cosmetic, food supplement, biocide or item of protective equipment. MDA decides on the intended purpose claimed by the manufacturer. MDA/GD/0063 (Third Edition, June 2025) lists 210 decisions harmonised across ASEAN. If yours is not listed, apply for a ruling before you import or sell.
How the decision is made
Check the claim. The test is the intended purpose as reflected in the specifications, instructions and information the manufacturer provides, so start with the label, the instructions for use and the marketing material.
Check it against the definition. Section 2 of Act 737 sets the medical purposes. Our definition guide covers the two tests.
Check the mode of action. If the product works mainly by pharmacological, immunological or metabolic means, it is not a device. See drug–device combination products.
Check MDA/GD/0063. MDA says it updates the list yearly to reflect the ASEAN Medical Device Committee’s latest decisions.
If it is still unclear, get a ruling from MDA, or from NPRA if the question is drug or cosmetic versus device.
What MDA/GD/0063 says about common products
A selection of the 210 entries, with the entry number from Annex A. The wording is shortened, so check the full entry before relying on it.
Beauty and aesthetics
Product
Decision
Entry
Laser used on the skin
Medical device with any medical claim; not a device if for aesthetic or cosmetic purposes
13
Liposuction machine
Medical device
14
Soft tissue or dermal filler
Medical device
60
Tattoo machine
Not a medical device
149
Tattoo needles and ink
Not a medical device
150
Eyes and vision
Product
Decision
Entry
Eye drops for soreness or irritation
Medical device if specifically for lubricating, disinfecting, cleaning, rinsing or hydrating contact lenses, or as a tear-replacing solution
20
Sunglasses with no power
Not a medical device
98
Spectacle lens with no power
Not a medical device
99
Wound care
Product
Decision
Entry
Plaster with povidone iodine, as a primary wound dressing
Nitric oxide nasal spray as an airborne virus barrier
Medical device
210
Recreational oxygen
Not a medical device
180
On the line with medicines
Product
Decision
Entry
Dental disinfectant or antiseptic
Medical device if the mode of action is physical; a medicine if pharmacological
3
Contrast media
Not a medical device
29
Medicinal patch for fatigue, aches or hormone imbalance
Not a medical device
56
Lubricant to reduce friction or ease penetration
Medical device
26
Home, care and everyday products
Product
Decision
Entry
Motorised bed for sleeping at home
Not a medical device
160
Electric scooter for short trips
Not a medical device
161
Air purifier for home use
Not a medical device
185
Diapers
Not a medical device
90
Telecare alarm that detects a fall from bed
Not a medical device
202
Hand gloves to reduce bacterial transfer
Medical device if with a medical purpose
22
Digital, laboratory and traditional practice
Product
Decision
Entry
Wristwatch
Not a device if it tracks heart rate, steps, sleep or stress for exercise or daily life and not for medical purposes; a medical device if it measures oxygen saturation, blood glucose, blood pressure, body temperature or ECG
118
Smartwatch measuring skin temperature, no diagnostic or medical purpose
Not a medical device
186
Software for information management and patient monitoring
Medical device if used to monitor patient data; not a device if used only for data storage
24
App for communication between patient and caregivers during birth
Not a medical device
23
Micropipette
Not a medical device, unless the manufacturer states it is for IVD purposes
1
Acupuncture needle
Medical device
12
Each decision applies to the intended use described in that entry. A home motorised bed (entry 160) is not a device, but a hospital bed is: it is a Class A medical device under the classification rules. Checked against MDA’s guidance document list on 9 November 2026.
MDA or NPRA?
MDA regulates medical devices under Act 737. Medicines and cosmetics go through NPRA. MDA and NPRA use the Medical Device–Drug–Cosmetic Interphase (MDDCI) table with four criteria: the primary intended purpose, the primary mode of action, the active ingredient, indication and dosage form, and how reference countries classify the product. A product with both a drug and a device part is a combination product, and the primary mode of action decides which agency leads. Our combination products guide explains both routes.
How to get a ruling
Question
Where to go
What you get
Medical device or not?
MDA’s online Product Classification Application System, RM300 per application on MDA’s published terms
A letter deciding whether it is a medical device, valid for 5 years if issued from 1 October 2026. It does not give the risk class
Drug or cosmetic versus device?
NPRA first, using product classification form NPRA 300.1, under the MDDCI flowchart
Not a medical device: MDA registration does not apply. Keep your claims within that position, because a medical claim can change the answer.
A medicine or cosmetic: it follows NPRA’s rules instead.
Jawapan ringkas · Bahasa Malaysia
Apakah produk sempadan (borderline) bagi peranti perubatan di Malaysia?
Produk sempadan ialah produk yang sukar dibezakan daripada peranti perubatan, contohnya yang mungkin ubat, kosmetik, makanan tambahan, biosid atau peralatan pelindung diri. MDA membuat keputusan berdasarkan tujuan penggunaan yang dinyatakan oleh pengilang. MDA/GD/0063 (Edisi Ketiga, Jun 2025) menyenaraikan 210 keputusan. Jika produk anda tiada dalam senarai, mohon keputusan klasifikasi daripada MDA, atau daripada NPRA jika persoalannya ialah ubat atau kosmetik berbanding peranti. WhatsApp 010-206 2070.
FAQ
Frequently asked questions
What is a borderline product in Malaysia?
MDA/GD/0063 defines borderline products as products that are difficult to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal protective equipment. They stay borderline until their status has been decided.
How is a borderline product decided?
On its intended purpose as claimed by the manufacturer. MDA/GD/0063 lists decisions harmonised by the ASEAN Medical Device Committee. For products on the line between medicine and device, the primary mode of action also matters: dental disinfectants, for example, are a medical device if the mode of action is physical and a medicine if it is pharmacological.
Is a skin laser a medical device in Malaysia?
It depends on the claim. MDA/GD/0063 treats a laser used on the skin as a medical device if there is any medical claim, and as a non-medical device if it is for aesthetic or cosmetic purposes only.
Is a smartwatch a medical device?
It depends on what it measures. MDA/GD/0063 lists a wristwatch that tracks heart rate, steps, sleep or stress for exercise or daily life, and not for medical purposes, as a non-medical device. One that measures oxygen saturation, blood glucose, blood pressure, body temperature or ECG is a medical device. A smartwatch that measures only skin temperature, with no diagnostic or medical purpose, is a non-medical device.
What if my product is not on the list?
Apply for a ruling. For device versus not a device, MDA’s online Product Classification Application System charges RM300 per application on MDA’s published terms, and letters issued from 1 October 2026 are valid for 5 years. The letter decides whether the product is a medical device; it does not give the risk class. For drug or cosmetic versus device, the MDDCI flowchart sends unlisted products to NPRA first.
Is my product regulated by MDA or NPRA?
Medical devices are regulated by MDA under Act 737. Medicines and cosmetics are regulated through NPRA. MDA and NPRA use the Medical Device–Drug–Cosmetic Interphase (MDDCI) table and MDA/GD/0063 to separate them, looking at the primary intended purpose, the primary mode of action, the active ingredient, indication and dosage form, and how reference countries classify the product.
If my product is not a medical device, can I make health claims?
Be careful. The decision depends on intended purpose, so adding a medical claim can turn a non-device into a medical device. Several entries in MDA/GD/0063 change category for exactly that reason. Other laws may also apply to the claims, depending on the product.
Launching a product that sits on the line?
Tell us what it does and how you plan to market it. We work out which regulator it falls under, apply for a ruling if needed, and register it if it is a device.