Selling medical devices online in Malaysia.
Act 737 applies to a Shopee, Lazada or TikTok Shop listing exactly as it does to a pharmacy shelf. In 2026 MDA started working with the platforms directly: keyword filters and seller demerits on Lazada, content monitoring on TikTok, and raids on companies selling unregistered gloves. Here is what each kind of seller needs.
Three checks before a device goes online.
- Is the device registered with MDA? Section 5 of Act 737 bars anyone from importing, exporting or placing an unregistered device on the market. “Place in the market” covers making a device available in Malaysia for payment or free of charge, new or reprocessed. Online sales are not excluded.
- Does the seller need an establishment licence? Manufacturers, importers, distributors and authorised representatives do (s.15), and with it GDPMD. Retailers do not: the Act’s definition of “establishment” excludes them.
- Is the listing a compliant advertisement? Only registered devices may be advertised, with no misleading claims (s.44). Public advertising of a registered device needs MDA approval (Advertising Regulations 2019, reg. 2), and every advertisement shows “Registered under Act 737” and the registration number.
What MDA did about online sales in 2026
| Date | Action | What it means for sellers |
|---|---|---|
| 14 April 2026 | MDA and the Malaysian Rubber Board (LGM) raid two companies in Shah Alam and inspect six premises in Kuala Lumpur and Selangor. One is suspected of placing unregistered devices on the market without a licence (ss.5 and 15), the other of distributing without a valid licence (s.15). Examination gloves worth about RM50,000 seized; MDA says the cases will go to prosecution. | Gloves are Class A devices. Selling them without registration and a licence is prosecuted, not just warned. |
| 12 May 2026 | MDA meets Lazada Malaysia. Lazada filters medical device sellers using MDA’s list of devices and keywords that may not be advertised online, and applies demerits, from light penalties up to stronger action, to sellers MDA finds in breach. | Listings can be blocked by keyword before anyone at MDA looks at them, and breaches count against the seller’s account. |
| 14 May 2026 | MDA meets ByteDance Malaysia on the sale and advertising of devices without MDA approval on TikTok, following earlier discussions, to improve monitoring and action against non-compliant content. | Live-stream and short-video selling is covered. Only MDA-registered devices should appear. |
| 14 May 2026 | MDA and KPDN’s enforcement division discuss complaints both agencies received about implant devices, and which agency’s powers apply. | Consumer complaints can reach MDA through KPDN as well as directly. |
Who needs what
| Seller | Device registered? | Establishment licence + GDPMD? | Advertising rules? |
|---|---|---|---|
| Brand owner or manufacturer selling direct | Yes, in its own name or through its AR | Yes (manufacturer) | Yes |
| Seller importing stock itself, e.g. from China, to sell online | Yes, held by the manufacturer’s Malaysian AR | Yes (importer) | Yes |
| Distributor or wholesaler supplying other sellers | Yes | Yes (distributor) | Yes |
| Retailer buying from a licensed Malaysian distributor | Yes | No (the Act excludes retailers) | Yes |
| Influencer, affiliate or agency promoting a device | The device must be | No | Yes: MDA/GL/04 counts them as advertisers |
The licence question turns on what the business does, not what it calls itself. A shop that orders containers from an overseas factory is an importer even if it only sells to consumers. Our establishment licence service and the MDA establishment licence guide cover the application. From 1 July 2027 each shipment will also need an import permit.
When a listing is an advertisement
MDA/GL/04 defines an advertisement as any statement, pictorial representation or design that directly or indirectly promotes the use or supply of a medical device, and says it includes “announcement of a public nature whether for the sale or purchase of medical device”. It defines an advertiser as anyone who uses printed or electronic media to advertise a device, naming celebrities, web designers and web hosts. Its application form lists Online Selling Platform Provider among applicant types and Other online selling platform beside YouTube, Facebook and Instagram as a medium.
- Needs MDA approval (RM1,000): listings, videos and live streams aimed at the public that make claims about what the device does, compare it with others, or use testimonials.
- No approval, but self-regulated under MDA’s Code of Advertisement: material with only product pictures, brand or logo and no claims, and exact replicas of the packaging MDA approved at registration.
- Never allowed: any advertisement of an unregistered device, including “coming soon” or pre-order listings while registration is pending, and claims beyond the registered intended purpose (s.44).
Fees, contents and validity of approvals are on our advertisement approval page.
Listing checklist
- The MDA registration number is current and the product, model and pack in the listing match the registration. Check MDAR, and watch the 5-year expiry.
- The listing states “Registered under Act 737”, the registration number and, if approval was needed, the advertisement approval number.
- Claims stay inside the registered intended purpose. Words such as “cures”, “100% safe” or a disease the device is not registered for are the usual triggers.
- Home-use devices carry Bahasa Malaysia labelling; see our labelling guide.
- Licensed sellers keep distribution records under GDPMD so recalls and problem reports can reach buyers; see recalls and FCAs.
- Second-hand and reconditioned devices follow MDA’s refurbishment rules; see refurbished devices.
Penalties and enforcement powers
| Offence | Provision | Maximum penalty |
|---|---|---|
| Importing or placing an unregistered device on the market | Act 737 s.5 | RM200,000, 3 years’ imprisonment, or both |
| Importing, exporting or placing on the market without an establishment licence | Act 737 s.15 | RM200,000, 3 years’ imprisonment, or both |
| Advertising an unregistered device, or misleading or 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 |
Part V of Act 737 gives MDA officers powers of search and seizure with or without a warrant, access to computerised data (s.53) and forfeiture of seized devices (s.63). Under section 71, MDA may, with the Public Prosecutor’s consent, compound an offence that regulations prescribe as compoundable, for up to half the maximum fine.
For buyers
Check the registration number on MDAR, MDA’s public register, before you buy. Buying a device abroad for your own use follows different rules; see personal-use imports. In August 2026 MDA announced that a hologram security label will be phased in for registered devices to help buyers spot fakes. It has not published dates or the device list yet; our labelling page tracks it.
Bolehkah saya menjual peranti perubatan di Shopee, Lazada atau TikTok Shop?
Boleh, jika peranti itu berdaftar dengan MDA (Akta 737 seksyen 5) dan iklannya mematuhi peraturan. Pengilang, pengimport dan pengedar memerlukan lesen establismen (seksyen 15) dan GDPMD; peruncit yang membeli daripada pengedar berlesen tidak memerlukan lesen. Iklan kepada orang awam memerlukan kelulusan MDA (RM1,000) dan mesti menyatakan “Registered under Act 737” serta nombor pendaftaran. Pada Mei 2026 MDA bekerjasama dengan Lazada (tapisan kata kunci dan sistem demerit) dan ByteDance (TikTok) untuk memastikan hanya peranti berdaftar dijual dalam talian. WhatsApp 010-206 2070.
Frequently asked questions
Can I sell medical devices on Shopee, Lazada or TikTok Shop?
Does an online retailer need an MDA establishment licence?
Is a marketplace listing an advertisement?
Do online listings need MDA advertisement approval?
What did MDA agree with Lazada in 2026?
What did MDA discuss with TikTok?
What are the penalties?
How can a buyer check that a device sold online is registered?
Listings blocked or demerited?
Send us the product, the listing and the registration number. We will check the registration and licence position, tell you which listings need MDA advertisement approval, and prepare the application or the registration that is missing.