Medical device advertisement approval in Malaysia.
A registered device advertised to the public needs MDA approval before the ad runs, carries a RM1,000 processing fee, and must show “Registered under Act 737”, the registration number and the approval number. An unregistered device cannot be advertised at all.
The decision in one table.
| Advertisement | MDA approval? | Basis |
|---|---|---|
| Any ad for a device that is not registered | Prohibited | Act 737 s.44(1) |
| Registered home-use device, any audience | Required | MDA/GL/04 §4.1(a) |
| Registered device, ad aimed at the general public (social media, website, TV, radio, print, outdoor) | Required | Regulations 2019 reg 2(1); MDA/GL/04 §4.1(b) |
| Ads aimed only at healthcare professionals or hospital procurement staff, not shown to the public | Not required; Code of Advertisement applies | MDA/GL/04 §1(a) |
| Pictures, brand or logo only, no claims (e.g. plain catalogue) | Not required | MDA/GL/04 §1(b) |
| Exact replica of the packaging MDA approved at registration | Not required | MDA/GL/04 §1(c) |
| Advertorials, disease-awareness and health-education campaigns, contests, sponsorship | Not required | MDA/GL/04 §1(d) |
“Not required” still means the content must follow MDA's Code of Advertisement (MDA/GD/0032), and no misleading or fraudulent claims are allowed anywhere (Act 737 s.44(2)).
What every advertisement must carry
Regulation 3 of the Medical Device (Advertising) Regulations 2019 requires a statement that the device is registered under the Act, plus its registration number. MDA/GL/04 (2nd edition, January 2022) sets the wording:
- the statement “Registered under Act 737”;
- the medical device registration number; and
- for ads that needed approval, the advertisement approval number.
The approved advertisement must run exactly as approved. Cautionary statements are encouraged.
How to apply
- Confirm the device is registered and the claims in the ad match its registered intended use. Claims outside the registration are the most common reason an ad cannot be approved as drafted.
- Prepare the submission (regulation 2(3)): a copy of the proposed ad, two colour copies or the script, and a frame-by-frame storyboard for video; a letter of appointment from the registering establishment if someone else is advertising; and certified translations for languages other than Malay and English (MDA/GL/04 §4.2).
- Pay the RM1,000 processing fee per application. It is non-refundable. MDA/GL/04 specifies hardcopy submission with a bank draft payable to “Kumpulan Wang Pihak Berkuasa Peranti Perubatan”; MDA's advertisement page now also links an online application form, so confirm the current channel there before paying.
- Answer any MDA request for further information within the period it sets (regulation 2(4)).
- Publish only after the approval number is issued, and add it to the ad.
One application or several?
- Same content in several languages and media: one application.
- Sound or video ads with the same script across TV, radio and other media: one application.
- Up to 5 devices per ad, or devices in one registration grouping.
How long approval lasts, and what ends it
- It ends automatically when the device registration expires. For a multi-device ad, when the earliest registration expires. This is one more reason to run the re-registration calendar early.
- A change notification that changes the device's claims invalidates the approval; apply again.
- Any content change, or the same ad in a new language, needs a new application. Editorial changes and picture swaps that do not change the message or claim do not.
Penalties
| Offence | Provision | Maximum penalty |
|---|---|---|
| Advertising an unregistered device, or misleading / fraudulent claims | Act 737 s.44 | RM300,000, 3 years’ imprisonment, or both |
| Advertising a registered device without MDA approval | Advertising Regulations 2019 reg 2(2) | RM200,000, 2 years’ imprisonment, or both |
The guideline's definition of advertiser is wide (publishers, PR agencies, celebrities, web designers and web hosts), and anyone advertising a device needs authorisation from the manufacturer or authorized representative. Aesthetic and home-use devices sold direct to consumers carry the most exposure; see our aesthetic device guide.
Adakah iklan peranti perubatan memerlukan kelulusan MDA?
Ya. Di bawah Peraturan-Peraturan Peranti Perubatan (Pengiklanan) 2019, iklan peranti berdaftar kepada orang awam dan iklan peranti kegunaan di rumah memerlukan kelulusan MDA. Fi pemprosesan RM1,000 setiap permohonan. Setiap iklan mesti memaparkan “Registered under Act 737”, nombor pendaftaran peranti dan nombor kelulusan iklan. Peranti yang belum didaftarkan tidak boleh diiklankan langsung (seksyen 44, Akta 737). WhatsApp 010-206 2070.
Frequently asked questions
Do medical device advertisements need MDA approval?
Which advertisements do not need approval?
Can an unregistered device be advertised?
How much does advertisement approval cost?
What must every medical device advertisement show?
How long is an advertisement approval valid?
Who applies, and who can be prosecuted?
How long does MDA take to approve an advertisement?
Planning a campaign for a medical device?
Send us the draft and the device’s registration number. We will tell you whether it needs approval, which claims the registration supports, and what to change before it goes to MDA.