MDA · Act 737 · Licences and approvals
Medical device licensing in Malaysia: every MDA licence and approval, and what each one costs.
Malaysia licenses medical devices at two levels: the company and the product. Then come the import permit, advertising, changes, export certificates and exemptions. We file all of them with MDA. Find yours in the table, then send us your details on WhatsApp for a written quote.
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
Short answer: to supply medical devices or medical equipment in Malaysia, the company needs an MDA establishment licence for each role (manufacturer, importer, distributor or authorised representative; MDA charges RM250 + RM2,000 to RM4,000) and every device needs an MDA registration (Class A–D). Importers add a per-shipment import permit from 1 July 2027, and adverts to the public need MDA advertisement approval. We handle the full set: licence with GDPMD for RM5,500 our fee, and registrations all-in from RM3,800 per device.
Medical device licences and approvals in Malaysia
“MDA fee” is what MDA charges. “Our service” is our fee; for device registration it already includes MDA and CAB fees, for the licence it does not.
| Licence or approval | Who needs it | MDA fee | MDA timeline | Our service |
|---|---|---|---|---|
| Establishment licence | Every manufacturer, importer, distributor and authorised representative; one licence per role since 1 July 2024 | New: RM250 + RM4,000 (manufacturer, AR) or RM250 + RM2,000 (importer, distributor). Renewal: RM200 + RM2,000 or RM1,000 | 14–21 working days for a complete application | RM5,500 with GDPMD; RM7,500 with ISO 13485 (manufacturers) |
| GDPMD certificate (licence prerequisite) | Importers, distributors and authorised representatives | Not an MDA fee: CAB audit RM4,785 per warehouse | Usually the longest step before the licence | Included in the RM5,500 above |
| Device registration (Class A–D) | The local manufacturer, or the authorised representative of a foreign manufacturer; every device | RM1,250 (A), RM1,250 (B), RM2,500 (C), RM3,750 (D), application + registration | Median 53 days submission to approval (our last 39) | All-in RM3,800 (A), RM6,800 (B), RM9,800 (C), RM12,000 (D), CAB and MDA fees included |
| Registration renewal | The registration holder, every 5 years; opens 1 year before expiry, impossible after expiry | As a new registration for the class | Apply in the final year of validity | RM6,000 per registration, all-in |
| Import permit | The importer, per shipment; enforcement postponed to 1 July 2027 | RM130 per application | Apply at least 7 days before shipment; processed in 3 working days | ePermit set-up and first applications, quoted |
| Advertisement approval | The advertiser, for adverts to the public; the device must be registered first | RM1,000 processing fee per application (up to 5 devices) | Valid until the device registration expires | Quoted per campaign |
| Change notification | The registration holder, when a registered device changes | RM30 to RM2,500 per certificate, by category and class | 30 or 60 working days | Quoted per change |
| Product classification letter | Anyone unsure whether a product is a medical device at all (it does not assign a class) | RM300 per application | Target 30 working days; letters from 1 Oct 2026 valid 5 years | Advice included when you register with us |
| Certificate of Free Sale (export) | Exporters of MDA-registered devices | RM100 (2 years) or RM300 (5 years) per registration number per country | 14 working days | Quoted with your export plan |
| Exemptions (special access, export only, demo units, custom-made) | The applicant named in the Exemption Order 2024 for each route | RM300 to RM500 per application, by route | Special access: 7 working days, letter valid 6 months | Quoted per application |
MDA registration fees by class are explained in full in our sister site’s guide to MDA registration fees. Our published consultancy fees are on the pricing page.
SequenceThe order to get them in
- Decide the roles. Importer, distributor, manufacturer, authorised representative: each is a separate licence since 1 July 2024. A foreign manufacturer appoints a local authorised representative instead of applying itself.
- Certify the quality system. GDPMD for importers, distributors and ARs; ISO 13485 for manufacturers. This gates the licence and takes the longest.
- Apply for the establishment licence in MeDC@St. 14–21 working days for a complete application.
- Register each device: classification, CSDT, CAB assessment for Class B–D, MeDC@St submission. Run it in parallel with steps 2 and 3 where possible.
- Then the market-facing approvals: advertisement approval before any public advert, the import permit per shipment from 1 July 2027, and a Certificate of Free Sale if you export.
- Keep it alive. GDPMD surveillance in years 2 and 3, licence renewal, registration renewal every 5 years, change notifications when a device changes.
Licensing mistakes we are usually called in to fix
- One licence assumed to cover every role. Since 1 July 2024 it does not; old multi-role licences are split at renewal.
- Bidding for a tender without a licence. Circular Letter No. 1/2026 has applied to every tender since 28 January 2026, Government and private, with no transitional exemption.
- Advertising before registration. Section 44 of Act 737 prohibits advertising an unregistered device: a fine of up to RM300,000, up to 3 years, or both.
- Letting a registration expire. Re-registration opens 1 year before the 5-year expiry; once it lapses there is nothing to renew, only a new registration.
- Selling online as a “retailer” while importing. The retailer exclusion does not cover a company that imports or distributes. See selling devices online.
- Missing MDA’s 2026 fee deadline. Licence fee payments and reimbursement requests for 2026 must be completed by 14 December 2026.
Why companies hand us their licensing
- We hold our own MDA establishment licence and act as authorised representative for foreign manufacturers
- 1,000+ device registrations with MDA since 2016, with a measured median of 53 days from submission to approval on our last 39
- Published fees: our fee and every MDA or CAB fee shown separately, before you ask
- One renewal calendar for your licence, certificates and registrations, so nothing lapses quietly
Want to check a supplier or distributor first? MDA publishes licensed establishments in its public search; our establishment licence page shows how to read the result.
Jawapan ringkas · Bahasa Malaysia
Lesen apa yang diperlukan untuk menjual peranti perubatan di Malaysia?
Syarikat memerlukan lesen establismen MDA bagi setiap peranan (pengeluar, pengimport, pengedar atau wakil sah; fi MDA RM250 + RM2,000 hingga RM4,000) dan setiap peranti mesti didaftarkan dengan MDA (Kelas A–D). Permit import bagi setiap penghantaran berkuat kuasa 1 Julai 2027, dan iklan kepada orang awam memerlukan kelulusan iklan MDA (RM1,000). Yuran kami untuk GDPMD dan lesen ialah RM5,500; pendaftaran peranti dari RM3,800 termasuk fi CAB dan MDA. WhatsApp 010-206 2070.
FAQ
Frequently asked questions
What licence do I need to sell medical devices in Malaysia?
Two, at two levels. Your company needs an MDA establishment licence for each role it plays (manufacturer, importer, distributor, authorised representative), under section 15 of Act 737. Each device needs its own MDA registration under section 5, held by the local manufacturer or, for a foreign manufacturer, its authorised representative. A distributor selling a device registered by someone else needs only its own licence, not a second registration.
Is an MDA licence the same as MDA registration?
No. The establishment licence covers the business; the registration covers the product. Hospitals and tender boards ask for both: Circular Letter No. 1/2026 requires a healthcare facility buying by tender to obtain the tenderer’s distributor licence and the registration certificate of each device, plus a letter appointing the tenderer from the authorised representative or distributor.
How long does medical device licensing take in Malaysia?
MDA processes a complete establishment licence application in 14–21 working days. For importers, distributors and authorised representatives, the GDPMD certificate has to come first, and that usually takes longer than the licence. Device registration took a median of 53 days from submission to approval on our last 39 new registrations (Class B–D also need a CAB conformity assessment before submission).
How much does an MDA licence cost?
MDA’s charge for a new establishment licence is RM250 to apply plus RM4,000 (manufacturer or authorised representative) or RM2,000 (importer or distributor). Renewal is RM200 plus RM2,000 or RM1,000. Our fee is RM5,500 with GDPMD for importers, distributors and ARs, or RM7,500 with ISO 13485 for manufacturers; the CAB or certification body audit and MDA’s fee are paid direct. Device registration with us is all-in: RM3,800 (Class A) to RM12,000 (Class D) per device.
Do I need a licence to sell medical devices on Shopee, Lazada or TikTok Shop?
The device must be registered either way. An importer or distributor selling online needs the establishment licence. A genuine retailer that buys registered devices from a licensed Malaysian distributor and sells them to end users does not, because Act 737 excludes retailers from “establishment”. A seller that imports its own stock, or supplies other sellers, is an importer or distributor. Our selling-online guide explains where the line falls.
Is there a deadline for 2026 licence fees?
Yes. MDA’s notice of 3 November 2026 says licence fee payments and reimbursement requests under the single licence policy must be completed by 14 December 2026, because MDA’s account closes on 21 December 2026. Requests after 14 December are not accepted.
Can you handle licensing for a foreign company with no Malaysian entity?
Yes. A foreign manufacturer cannot hold a Malaysian registration itself; it appoints a locally incorporated authorised representative. We act as that AR under our own MDA establishment licence, hold the registrations and handle MDA correspondence, vigilance and renewals.
One consultant for every MDA licence
Tell us what you do and what you sell. You get the licences you need, in order, with MDA's fees and ours listed separately.