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AA Alive Sdn Bhd · SSM 1204108-DMDA-licensed practiceSuperbrands Malaysia 20251000+ devices registered
Medical Device Consultant.MY
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Act 737 · Manufacturer licence · ISO 13485 · MDA registration

Medical device manufacturing consultant in Malaysia: licensed, certified and registered in one programme.

For local manufacturers, own-brand companies and contract manufacturers. We work out who the legal manufacturer is, build the ISO 13485 system, file the MDA manufacturer licence and register each device, so your first shipment is legal in Malaysia and the same file carries you into export markets.

See published fees
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export

Short answer: to manufacture and sell medical devices in Malaysia you need three things: an ISO 13485 quality system, an MDA manufacturer establishment licence (MDA charges RM250 + RM4,000) and an MDA registration for every device. Our fee for ISO 13485 and the licence application is RM7,500, with the certification body’s audit and MDA’s licence fee paid direct. Registration is all-in from RM3,800 (Class A) to RM12,000 (Class D) per device.

Step 0 · Act 737, section 2

First question: are you the manufacturer?

Act 737 does not ask who owns the machines. It asks who is responsible for the device and puts it on the market under their own name. That decides who holds the licence, who registers the device and who answers to MDA when something goes wrong.

Your situationLegal manufacturer under Act 737What you need
You design and make the device in your own plant, under your brandYouISO 13485, manufacturer licence, registration of each device
Your brand, but a factory (local or overseas) makes it for youYou. The Act counts operations done “by a subcontractor acting on the person’s behalf”ISO 13485 covering how you control the factory, manufacturer licence, registration. Importer licence too if the factory is overseas
You relabel, repack or assemble ready-made devices and sell them under your own nameYou, under paragraph (b) of the definitionThe same as a manufacturer, which surprises many distributors moving into private label
You make devices for another company’s brand (OEM / contract manufacturing)The brand owner. Your plant is its subcontractorISO 13485 so the brand owner and its regulators can rely on you. Malaysian registration only if the output is sold here; export-only devices can be exempted

Definitions from section 2 of the Medical Device Act 2012 (Act 737). A retailer is not an establishment; a distributor that starts selling under its own name is.

The programme

From factory floor to registered device, in order

  1. Scope and classify. List every device and family, apply the classification rules (Rules 1–16, First Schedule of the Medical Device Regulations 2012) and plan the grouping, which is where multi-device budgets are cut. See device classification.
  2. Build and certify the ISO 13485 system. Design controls, supplier and subcontractor control, production and process validation, sterilisation where it applies, complaint handling. It has to run long enough to produce records before the certification body’s stage 1 and stage 2 audits, so this is the longest step: several months for an SME. Details on our ISO 13485 page.
  3. Apply for the manufacturer licence in MeDC@St with the certificate and company documents. MDA charges RM250 to apply plus RM4,000 for the licence, and processes a complete application in 14–21 working days. One licence per role since 1 July 2024: if you also import components or finished devices, that is a second licence.
  4. Write the technical file and register each device. The CSDT under MDA/GD/0008, conformity assessment by a CAB for Class B, C and D (Class A goes straight to MDA), then the MeDC@St application. On our last 39 new registrations the median was 53 days from submission to approval.
  5. Run the post-market duties. Complaint handling, distribution records, mandatory problem reporting and recalls under the Medical Device (Duties and Obligations of Establishments) Regulations 2019.
  6. Export. An MDA Certificate of Free Sale for registered devices (from RM100 per country), then MDSAP, CE marking or FDA 510(k) on the same quality system and technical core.

Contract manufacturing for export only

Many Malaysian plants make devices that never reach a Malaysian patient. Devices made only for export can be exempted from registration under paragraph 3(1)(f) of the Medical Device (Exemption) Order 2024: the manufacturer or exporter applies to MDA, the charge is RM500 per device nomenclature, and the letter is valid for 5 years. Paragraph 4 of the Order then lifts the establishment licence for a person who imports or exports those devices. With the exemption letter, MDA issues an Export Certificate (RM250 plus RM100 for 2 years or RM300 for 5 years, per country) for customers whose regulators want proof from Malaysia.

Two cautions. The exemption ends the moment any unit is sold in Malaysia: then the device needs registration and the plant needs its licence. And your customer’s regulator (FDA, a notified body, MDSAP auditors) will still expect a working ISO 13485 system at your site, so the export-only route saves registration fees, not the quality system.

Fees: our fee, and the fees you pay direct

ItemOur feePaid direct (not included)
ISO 13485 system + MDA manufacturer licence application (year 1)RM7,500Certification body audit RM7,500; MDA manufacturer licence RM4,250 (RM250 application + RM4,000 licence)
ISO 13485 surveillance (years 2 and 3)RM4,000/yrCertification body surveillance audit RM5,000/yr
Device registration, per device (all-in)RM3,800 (A) · RM6,800 (B) · RM9,800 (C) · RM12,000 (D)None: CAB and MDA fees included
Manufacturer licence renewalQuoted with your surveillance cycleMDA renewal fee RM2,200 (RM200 application + RM2,000 renewal)
Export: CFS, MDSAP, CE marking, FDA 510(k)Quoted after scopingMDA CFS from RM100 per country; audit and agency fees per market

Multi-device packages (for example 3 Class B devices RM18,000 all-in) and payment plans from RM1,500 a month are on the pricing page. Quotations are itemised and usually issued within one working day.

Why manufacturers use us

  • We hold our own MDA establishment licence and run a GDPMD-certified system, so we work to the same rules we write for you
  • 1,000+ device registrations with MDA since 2016; measured median of 53 days from submission to approval on our last 39
  • One documentation core: the CSDT, risk file and QMS records are written to be reused for MDSAP, CE and FDA
  • Published fees, with our fee and every fee paid to MDA or a certification body shown separately

For the certification process itself (stage 1 and stage 2, choosing a certification body), our sister site has a step-by-step guide to ISO 13485 certification in Malaysia.

Jawapan ringkas · Bahasa Malaysia

Apa yang diperlukan untuk mengeluarkan peranti perubatan di Malaysia?

Pengeluar memerlukan sistem kualiti ISO 13485, lesen establismen pengeluar daripada MDA (fi MDA RM250 permohonan + RM4,000 lesen) dan pendaftaran MDA bagi setiap peranti. Pemilik jenama yang menggunakan kilang lain tetap dikira sebagai pengeluar di bawah Akta 737. Yuran kami untuk ISO 13485 dan permohonan lesen ialah RM7,500; pendaftaran peranti RM3,800 hingga RM12,000 setiap peranti termasuk fi CAB dan MDA. WhatsApp 010-206 2070 untuk sebut harga bertulis.

FAQ

Frequently asked questions

Do I need a manufacturer licence to make medical devices in Malaysia?
If you are the manufacturer under Act 737 and you place devices on the Malaysian market, import or export registered devices, yes. Section 15(1) says no establishment shall import, export or place in the market a registered medical device without an establishment licence, and a manufacturer is an establishment. Since 1 July 2024 each role is a separate licence, so a manufacturer that also imports needs both. MDA charges RM250 to apply plus RM4,000 for the manufacturer licence, and processes a complete application in 14–21 working days.
I sell devices under my own brand but a factory makes them. Am I the manufacturer?
Yes. Act 737 defines the manufacturer as the person responsible for design, production, assembly, packaging and labelling “whether or not it is the person, or a subcontractor acting on the person’s behalf, who carries out these operations”, and who puts the device on the market under its own name with its intended purpose. The brand owner carries the manufacturer’s duties; the factory is its subcontractor. The same applies if you relabel or repack ready-made devices under your own name (paragraph (b) of the definition).
We are a contract manufacturer making devices for a foreign brand. What do we need?
The foreign brand owner is the legal manufacturer; your plant is its subcontractor, and the brand owner’s regulators will audit you against ISO 13485. If the devices are made only for export, they can be exempted from Malaysian registration under paragraph 3(1)(f) of the Medical Device (Exemption) Order 2024 (application to MDA, RM500 per device nomenclature, valid 5 years), and paragraph 4 of the Order lifts the establishment licence for whoever imports or exports them. If any of the output is sold in Malaysia, registration and licensing apply in full. We confirm your position with MDA before you rely on it.
How long does it take to become a licensed manufacturer?
The ISO 13485 system is the long step: several months for an SME, because the system has to run long enough to produce real records before the certification body’s stage 1 and stage 2 audits. The MDA licence is quick once the certificate exists (14–21 working days for a complete application). Device registration runs in parallel with the end of the QMS work; on our last 39 new registrations the median was 53 days from submission to MDA approval.
What does it cost?
Our fee is RM7,500 for year 1, covering the ISO 13485 system and the MDA manufacturer licence application. Paid direct by you, not to us: the certification body’s audit (RM7,500) and MDA’s manufacturer licence fee (RM4,250: RM250 application + RM4,000 licence). Device registration is all-in per device: RM3,800 (Class A), RM6,800 (Class B), RM9,800 (Class C) or RM12,000 (Class D), CAB and MDA fees included. ISO 13485 surveillance in years 2 and 3 is RM4,000 a year our fee plus RM5,000 a year to the certification body. Payment plans from RM1,500 a month.
Can the same system get us CE marking or FDA clearance later?
That is the point of building it properly once. ISO 13485 is the base for MDSAP (one audit accepted by the USA, Canada, Brazil, Australia and Japan), for CE marking under EU MDR and for FDA’s QMSR. The CSDT technical file we prepare for MDA is written so its engineering core can be reused in an EU technical file or a 510(k). Malaysian-registered devices can also get an MDA Certificate of Free Sale for export markets, from RM100 per country.
What duties start once we are licensed?
A licensed manufacturer is a duty holder under Act 737 and the Medical Device (Duties and Obligations of Establishments) Regulations 2019: complaint handling, distribution records, mandatory problem reporting to MDA (within 48 hours, 10 days or 30 days depending on severity, section 40), field corrective actions and recalls, and keeping registrations and the licence renewed. We can run these for you on a post-market surveillance retainer.

Planning a device plant or an own-brand range?

Tell us what you make and where it will be sold. We map the licence, the quality system and the registrations in the right order, with a written quote.

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