MDA registers devices, licenses companies and approves advertisements. Mixing up those three words is how a compliant gel ends up in a non-compliant box.
Disclosure: This article is published by ORIZI Group and may refer to our own manufacturing experience, services and capabilities. External factual claims are supported by cited sources.
Key takeaways
- Three different permissions: an establishment licence covers the company, a registration covers the device, and an advertisement approval covers one advert.
- The registration number is mandatory on the label within six months of registration, where buyers see it at the point of sale.
- No endorsement wording: MDA’s FAQ says using the names KKM or MDA as an endorsement on a label is not allowed.
- Home-use devices need Bahasa Malaysia on the label itself.
- Advertising rules reach the pack: MDA applies its Code of Advertisement to all labelling, so “guaranteed”, “best” and “no side effects” are out.
What this guide covers
This guide is for brand owners, pharmacy chains and distributors preparing packs, leaflets and marketing for medical devices sold in Malaysia, especially low-risk consumer products such as scar gels, barrier creams, mouth-ulcer gels and lubricants. It draws on the Medical Device Act 2012 (Act 737), MDA’s labelling guidance MDA/GD/0026 (7th Edition, May 2026), its Code of Advertisement and its FAQs, checked in October 2026. Classes, fees and timelines for registration are in our step-by-step guide to MDA registration.
An establishment licence is the company-level licence that Section 15 of Act 737 requires before a manufacturer, authorised representative, importer or distributor may import, export or place registered devices on the market. A medical device registration is the product-level listing that Section 5 requires before any device is imported, exported or placed on the market. An advertisement approval is MDA’s permission for a specific advertisement under the Medical Device (Advertising) Regulations 2019, enforced since 1 January 2022. A home-use medical device is one intended for lay users outside a professional healthcare facility.
Is “MDA approved” a legal claim in Malaysia?
“MDA approved” is not a recognised status for a medical device in Malaysia. Act 737 speaks of devices being registered and establishments being licensed. MDA/GD/0026 then states that a label must not contain any statement that, directly or indirectly, suggests the device’s placement on the market, use or operation is promoted or endorsed by the Authority, the Ministry of Health or any of its bodies. MDA’s labelling FAQ adds that using the names KKM or MDA already signals endorsement and is not allowed; its one exception is supply to the Ministry of Health, where “Kementerian Kesihatan Malaysia” may be printed if the supply instruction requires it.
The search data show why the confusion persists: “mda approved” draws 100–1,000 searches a month in Malaysia, against 10–100 for “mda registered” (Google Keyword Planner, September 2025–August 2026). Shoppers look for the approval wording; the law describes the registered status.
Licence, registration or approval: what is the difference?
| Permission | Covers | Legal basis | Held by | What it does not mean |
|---|---|---|---|---|
| Establishment licence | The company, per activity: manufacturer, authorised representative, importer, distributor | Act 737, s.15 | The establishment; one licence per activity | Not proof that any particular device is registered |
| Device registration | A device, for its registered intended use and risk class | Act 737, s.5 | Registered by a licensed manufacturer or authorised representative; valid five years | Not permission to advertise, and not an endorsement |
| Advertisement approval | One advert for a home-use device or aimed at the public | Act 737, s.44; Advertising Regulations 2019 | The advertiser, authorised by the manufacturer or representative | Lapses when the registration expires or registered claims change |
Each has its own cost. MDA’s licensing guidance (MDA/GD/0027) lists an RM250 application fee plus RM4,000 for a manufacturer or authorised representative licence and RM2,000 for an importer or distributor licence; an advertisement application costs RM1,000. Which licence a brand owner needs depends on what it does: a retailer selling only to the public is not an establishment, but MDA/GD/0027 says retailers, including online retailers, that carry out manufacturing (as brand owner), importation, exportation or distribution need the matching establishment licence.
What must a medical device label in Malaysia show?
| Requirement | What MDA/GD/0026 asks for |
|---|---|
| Registration number | The Malaysian registration number, added within six months of registration; the certificate’s QR code is encouraged |
| Placement | Number, manufacturer or authorised representative details and QR code where they can be seen at the point of sale |
| Identification | Device name and model; batch, lot or serial number |
| Dates | Use-by date as at least year and month where relevant; otherwise a manufacturing date |
| Company details | Local manufacturer or authorised representative: name, address and at least one contact detail |
| Use and safety | Intended purpose where not obvious, instructions, warnings, precautions, storage and disposal information |
| Language | Bahasa Malaysia for home-use devices, on the label itself; English for other devices |
| Consistency | Content as submitted at registration; stickers allowed only if they do not cover lot, serial or dates |
On MDA’s public register, registration numbers take a form such as GA8144626-227266: a code, not a statement. Label claims also decide whether a product is a device at all, as our guide to telling a cosmetic from a medical device explains.
What wording can and cannot go on the pack?
MDA/GD/0026 says the Code of Advertisement (MDA/GD/0032) applies to all labelling information, so advert wording rules also govern boxes, tubes and leaflets.
| Wording on the pack | Allowed? | Basis |
|---|---|---|
| “Medical Device Registration No.” or “Malaysia Reg. No.” plus the number, or the number alone | Yes | Formats in MDA’s fifth-edition amendment list |
| “MDA approved”, “KKM approved”, “Lulus KKM” | No | Endorsement (MDA/GD/0026 clause 4.1c; MDA FAQ) |
| “Kementerian Kesihatan Malaysia” | Only for supply to the Ministry under its instruction | MDA FAQ |
| CE marking or other countries’ approvals | Yes | MDA FAQ |
| Halal logo | Only with JAKIM certification | MDA FAQ |
| Claims beyond the registered intended use | No | Code of Advertisement 4.4 |
| “No side effects”, “no harmful effects” | No | Code of Advertisement 4.4.12 |
| “Best”, “guaranteed”, “miracle”, “anti-ageing” | No | Code of Advertisement, Annex B |
| “Natural” | Only if all components are naturally sourced | Code of Advertisement 4.4.10 |
MDA’s fifth-edition amendment list for MDA/GD/0026 also accepted “MDA Reg. No.” in front of the number. The current edition no longer lists formats, so the neutral options above are the safer choice.
Do adverts, social posts and marketplace listings need MDA approval?
Yes, when the device is for home use or the advert targets the general public. MDA’s advertisement guideline (MDA/GL/04) requires every advert to carry the statement “Registered under Act 737”, the registration number and, where approval is required, the approval number; MDA publishes approved adverts with numbers such as MDAMD 0001/2022. The Code of Advertisement covers internet advertising too. Approval is tied to the registration and becomes invalid when it expires or the registered claims change. For which pharmacy-shelf devices are registered locally today, see our analysis of the MDA register.
ORIZI perspective: the label check we run before print
ORIZI Group makes medical devices through Imedify Medical Solution Sdn. Bhd. and Skyler Medical Manufacturing Sdn. Bhd., both operating under MDA establishment licences with ISO 13485 quality systems (Imedify certified since 2024, Skyler since 2022). On MDA’s public register, a wound-care product Imedify manufactured for a client brand shows a GA-prefixed registration valid from 2 March 2026 to 1 March 2031. That number is the identifier the label must carry; there is no separate approval line to print.
For low-risk topical devices our artwork review covers five points: the registration number and company details sit on the panel a shopper sees at the shelf; every claim matches the registered intended use; home-use packs carry Bahasa Malaysia; nothing suggests MDA or Ministry endorsement; and no Code of Advertisement words such as “guaranteed” survive. When a brief asks for “MDA approved” on the front panel, the compliant alternative is the registration number in neutral wording. Limits: this reflects one group’s experience with low-risk topical devices under the May 2026 guidance; higher-risk devices carry extra duties such as sterility and reuse information.
Common mistakes on medical device packaging
- Endorsement lines such as “MDA approved” or “KKM approved” on the front panel.
- A registration number hidden inside the carton, or missing after the six-month window.
- Claims that drift from the registered intended use, such as adding “heals” to a product registered to protect.
- English-only packs for home-use devices.
- Stickers over the lot number or expiry date when adding importer details or translations.
- Running influencer or marketplace ads before approval, or after the registration lapses.
FAQ
Is “MDA approved” a legal claim in Malaysia?
No. Malaysian law registers medical devices and licenses establishments; it does not grant an “approval” to print on a pack. MDA’s labelling guidance prohibits any label statement suggesting MDA or the Ministry of Health endorses the device. Print the registration number instead.
Where must the MDA registration number appear on the pack?
On the packaging where customers can see it at the point of sale, together with the manufacturer or authorised representative details and, if available, the QR code from the registration certificate.
How long do I have to add the registration number after registration?
Six months. MDA/GD/0026 requires a registered device to carry its Malaysian registration number within six months of registration, and MDA’s FAQ says adding it to a newly registered product needs no change notification.
Can I print “KKM” or “Kementerian Kesihatan Malaysia” on a device label?
Not as a sign of approval. MDA’s labelling FAQ says using the names KKM or MDA signals endorsement and is not allowed; “Kementerian Kesihatan Malaysia” may appear only when supplying the Ministry under an instruction that requires it.
Does a medical device label need Bahasa Malaysia?
Yes for home-use devices: label information must be in Bahasa Malaysia, except brand names, proper nouns and words that are the same in both languages. Devices for professional users are labelled in English, and other languages may be added.
Does my brand need its own MDA establishment licence?
It depends on your role. A retailer selling only to the public is not an establishment, but MDA’s licensing guidance says retailers that act as brand owner, importer, exporter or distributor need the matching licence, one per activity. Agree with your manufacturer early who is the registrant and legal manufacturer on the device record.
Sources & references
- MDA — Medical Device Act 2012 (Act 737) — sections 2, 5, 15 and 44
- MDA — MDA/GD/0026 Requirements for Labelling of Medical Devices, 7th Edition (May 2026) — registration number, endorsement ban, placement, contents, language, COA link
- MDA — FAQs: Labelling of Medical Devices — KKM and MDA names, other approvals, Halal logo, translation, change notification
- MDA — MDA/GD/0026 fifth-edition amendment list — accepted registration-number formats
- MDA — MDA/GD/0032 Code of Advertisement — claims, safety claims, natural claims, prohibited superlatives
- MDA — MDA/GL/04 Medical Device Advertisement Approval — which adverts need approval, required statements, RM1,000 fee, validity
- MDA — List of approved medical device advertisements — enforcement from 1 January 2022, approval number format
- MDA — MDA/GD/0027 Licensing for Establishment — licence types, retailers, fees
- MDA — Malaysia Medical Device Register search — registration number format, five-year validity and the Imedify record (checked October 2026)
Update history: October 2026 — first published.
Preparing packaging for a medical device? See what we manufacture and register on our OEM medical device page, browse examples such as scar gel, or send us your draft artwork and intended claims for review.
