Medical Device Advertising Compliance: Act 737 Section 44 and the COA Code

1. Key takeaways

Advertising a medical device in Malaysia is lawful only where the device is lawfully registered and the claims made match the registration. Section 44(1) of Act 737 prohibits advertising a device that is unregistered or that does not comply with the requirements of the Act. Section 44(2) prohibits advertising that contains misleading or fraudulent claims. Under the Medical Device (Advertising) Regulations 2019, advertising a registered device requires MDA approval, and the supporting standard is the Code of Advertisement (COA), MDA/GD/0032, of December 2020.

Two categories of advertising must be approved, and the approval number must appear in the advertisement itself. The regime therefore regulates not only what is said but whether the saying was authorised, which is why unregistered promotional content is exposed on two grounds at once.

• Two approval categories: advertising for home-use devices, and advertising directed at the general public.
• Applicant: the advertiser, being the manufacturer, the AR or a third party authorised by them, through the MDA advertising application channel.
• Approval number: must be displayed in the advertisement.
• Mandatory statements: the statement that the device is registered under Act 737, the device registration number, and, where approval is required, the advertising approval number.
• Claim standard: claims must be strictly consistent with the approved registration, including intended use, and must be documented.
• Prohibited: exaggerated, unsupported or unapproved claims; superlative expressions (Annex B); disease-implying expressions (Annex A).
• Media coverage: any medium — print, electronic or online — including website product pages, social media and exhibition material; third-party operators require manufacturer or AR authorisation.

2. Legal basis

The architecture has three layers. Section 44 sets the statutory prohibitions. The Medical Device (Advertising) Regulations 2019 impose the approval requirement for advertising of registered devices. The COA provides the ethical standard against which the content of an advertisement is assessed, and it does so by reference to the registration rather than to general marketing practice. That reference point is the key to the whole regime: the approved intended use is the boundary of what may lawfully be claimed.

The COA also carries two annexes that operate as negative lists. Annex A addresses diseases and conditions, and Annex B addresses superlative expressions. Both are absolute in character, which means that a claim caught by either annex cannot be rescued by adding substantiation elsewhere in the material.

3. Expert insights

Insight 1: the registration is the ceiling for every claim.

The COA does not ask whether a claim is true in the abstract; it asks whether the claim is consistent with what was approved. A statement may be scientifically defensible, well referenced and commercially important, and still be non-compliant because the approved intended use does not reach it. This is a structural constraint rather than a drafting preference, and it means that the regulatory function has to review promotional content against the registration file rather than against the evidence file alone. Where a claim matters commercially but sits outside the approval, the route is a change to the registration, not a more persuasive advertisement.

Insight 2: absolute prohibitions cannot be argued around.

Annex B bars superlative expressions and Annex A bars disease-implying expressions. Both are categorical. The instinct of a marketing team facing an absolute prohibition is to seek a synonym, and the instinct is wrong: the prohibition is on the effect produced on the reader, not on a specific list of words. The observation that this mirrors the absolute-terms prohibition familiar from Chinese advertising law is useful precisely because it warns against word-level substitution. The control that works is a review step that asks what the material communicates, not which words were used.

Insight 3: the approval requirement depends on the audience, not on the budget.

The two approval categories are defined by audience: advertising for home-use devices, and advertising directed at the general public. A small social media post aimed at patients can therefore require approval that a large exhibition stand aimed exclusively at clinicians does not. Budget and production value are irrelevant to the question. The practical consequence is that the approval decision has to be taken at the concept stage, because retrofitting an approval number into finished material is both slower and more expensive than planning for it.

Insight 4: digital and third-party content is inside the definition.

The definition of advertising covers statements in any medium — print, electronic or online — that promote the use of a device. Website product pages, social media posts and exhibition materials all fall within it. A distributor or agency that operates a channel on the manufacturer’s behalf does not take the content outside the regime: the manufacturer or AR must authorise the activity, and the content must comply in the same way as material produced in-house. The common failure is a local page maintained by a partner that nobody in the regulatory function has ever reviewed.

Insight 5: mandatory statements are a formatting obligation with legal effect.

The statement that the device is registered under Act 737 and the device registration number must appear, and where approval is required the advertising approval number must appear as well. Warnings are encouraged rather than mandatory, but all statements must be presented clearly. Clarity is the operative word: a registration number buried in a footer at a size that cannot be read does not discharge the obligation in substance, even if it does so on paper.

Insight 6: the same discipline protects the vigilance file.

Advertising exposure and post-market exposure draw on the same evidence base, so a single discipline serves both. Maintaining an incident discovery ledger that records, for each event, the date of awareness, the model or batch involved, local distribution, the severity judgement and the dates of the initial and investigation reports gives an inspector a reconstructable history. In an inspection, that ledger is the defence.

4. Practical recommendations

• Review every asset against the registration, not the literature. The approved intended use defines the outer limit of permissible claims.
• Decide on approval at concept stage. Ask who the audience is before commissioning creative work.
• Build a claim library. Pre-cleared wording that sits inside the approved intended use reduces review time without reducing control.
• Screen for effect, not vocabulary. Test material against Annex A and Annex B by asking what a reader would understand.
• Register every channel, including partner-run pages. Maintain a list of domains, accounts and exhibition assets with a named owner for each.
• Authorise third-party operators in writing. The mandate should require prior approval of content and give the AR a right of removal.
• Apply the statutory statements as a checklist item. Registration statement, registration number and approval number where required, all legible.
• Keep an incident discovery ledger. Record awareness date, model or batch, local distribution, severity judgement, and the dates of the initial and investigation reports.

5. Verification checklist

• □ Act 737 section 40 confirmed in the current text
• □ Medical Device (Duties and Obligations of Establishments) Regulations 2019, regulation 5 reviewed
• □ MDA/GD/0014 Mandatory Problem Reporting reviewed
• □ MDA Vigilance Unit page checked for reporting criteria and timelines (updated 20 February 2023)
• □ Advertising review procedure mapped to sections 44(1) and 44(2) and to the COA

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Malaysia. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the MDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com