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Medical Device Consultant.MY
AA Alive Sdn Bhd · Medical Device Regulatory Practice · Est. 2016

Malaysia's end-to-end medical device
regulatory partner.

From your first MDA registration to CE marking and FDA clearance — one team that has registered 100+ devices carries you up the whole ladder. Our prices are published and all-inclusive (no other firm in this market does that), our submissions run at a 98% success rate, and the documentation we build for Malaysia is structured to be reused in every export market.

See services & pricing
ACT 737 · MDAGDPMDISO 13485MDSAPEU MDR · CEFDA 510(K)
100+medical devices registered with MDA
98%approval success rate — typically approved within 3 months
Since 2016GDPMD, ISO 13485 & licensing practice under AA Alive Sdn Bhd (1204108-D)
National mediafounder featured on BERNAMA TV & RTM as a device-industry consultant
The export ladder

One team, five rungs — from Batu Caves to the world.

Most consultancies sell one rung and hand you off. We designed our practice around the whole climb, because the documentation you build at stage one decides how expensive stage five will be. Every engagement starts by placing you on this ladder.

  1. MDA Registration

    Device registered under Act 737

  2. GDPMD + Licensing

    Establishment licensed to place devices on the market

  3. ISO 13485 QMS

    Manufacturer-grade quality management system

  4. MDSAP

    One audit accepted in five markets

  5. CE / FDA Export

    EU MDR and US market clearance

Services

Everything a device business needs to enter, stay and expand.

Enter the Malaysian market

STAGE 01

MDA Device Registration

Classification, CSDT documentation and MeDC@St submission under Act 737 — from RM2,500 per device, CAB and MDA fees included.

View service →STAGE 02

MDA Establishment License

The license every device business needs before selling — all-inclusive packages from RM18,000 (GDPMD + license, CAB and MDA fees included).

View service →STAGE 02 · RECURRING

GDPMD Certification

Gap analysis to CAB certification — RM10,000 all-in (CAB fees included), with annual renewal from RM2,500/yr.

View service →STAGE 02 · RECURRING

Authorized Representative

The legally required local representative for foreign manufacturers — registration holder, vigilance contact and license custodian on an annual retainer.

View service →STAGE 01

Technical File / CSDT

CSDT dossiers for MDA, EU MDR technical documentation and 510(k) content — one documentation core reused across markets.

View service →

Stay compliant

STAGE 03

ISO 13485

Manufacturer-grade quality management system implementation and certification support — the backbone of MDSAP, CE and FDA readiness.

View service →STAGE 03 · RECURRING

Post-Market Surveillance

Complaint handling, vigilance reporting, distribution records and recall readiness run as a managed monthly retainer.

View service →

Go global

STAGE 04

MDSAP

Medical Device Single Audit Program readiness built on your ISO 13485 system — accepted in the USA, Canada, Brazil, Australia and Japan.

View service →STAGE 05

CE Marking (EU MDR)

Classification, technical documentation, notified body liaison and EU authorized representative coordination for the European market.

View service →STAGE 05

FDA 510(k)

Predicate strategy, eSTAR submission, FDA registration & listing and US agent coordination — the USA is Malaysia’s largest device export market.

View service →
Compliance is not a one-off

Registrations expire. Certificates lapse. We keep score so you don't.

Everything you win in steps one and two runs on a cycle: GDPMD and ISO 13485 certificates renew yearly (RM2,500/yr), the establishment license every 3 years (RM9,000), each product registration every 5 years (RM6,000) — all published, all-inclusive. Add the authorized representative and post-market surveillance retainers, and nothing on your license portfolio ever quietly expires. Prefer smooth cash flow? Register your medical device in Malaysia from RM1,500/month on a payment plan.

See the plans
  • Renewal calendar for every registration and certificate we hold for you
  • GDPMD annual surveillance audit preparation
  • Complaint, vigilance and recall handling on retainer
  • Change notifications when your device, labeling or supplier changes
  • One consultant who already knows your file — no re-onboarding
Who you'll work with

A practice built by an operator, not a paperwork shop.

Medical Device Consultant Malaysia is the regulatory arm of AA Alive Sdn Bhd, founded in 2016 by Evin Lim — a medical device industry consultant who also runs device supply businesses, so he has sat on your side of the MDA counter. His industry commentary has been featured on BERNAMA TV and RTM, and the group holds Superbrands Malaysia recognition.

About the practiceMedia coverage
Jawapan ringkas · Bahasa Malaysia

Berapa kos pendaftaran peranti perubatan di Malaysia?

Harga kami diterbitkan dan sudah termasuk fi CAB serta fi MDA: RM2,500 (Kelas A), RM6,000 (Kelas B) dan RM9,800 (Kelas C) bagi setiap peranti; pakej lesen establishmen dari RM18,000. Pelan bayaran bulanan dari RM1,500 sebulan, kadar kejayaan 98%, kebiasaannya lulus dalam 3 bulan. Lihat panduan penuh di halaman kos pendaftaran peranti perubatan atau WhatsApp kami di 011-2410 2070.

FAQ

Frequently asked questions

Do I need to register my medical device in Malaysia?
Yes. Under the Medical Device Act 2012 (Act 737), a medical device must be registered with the Medical Device Authority (MDA) before it can be imported, exported or placed on the Malaysian market, and the business handling it must hold an establishment license. We manage both, end to end.
What does a medical device consultant cost in Malaysia?
Our prices are published and all-inclusive (CAB and MDA fees inside): device registration RM2,500 (Class A), RM6,000 (Class B), RM9,800 (Class C) per device; establishment license packages RM18,000 (Importer + Distributor) or RM25,000 (with Authorised Representative); GDPMD alone RM10,000. Payment plans from RM1,500/month. See the pricing page for the full three-step schedule.
Can one firm handle MDA registration and export approvals like CE or FDA?
That is exactly how we work. The same technical documentation core we build for your MDA registration is structured to be reused for EU MDR technical files, FDA 510(k) submissions and MDSAP audits — so each market entry costs less than starting again with a new consultant.
How long does medical device registration take in Malaysia?
Registrations we manage are typically approved within 3 months, at a 98% success rate. Class A notifications are the fastest; Class B–D registrations need conformity assessment by a registered CAB before MDA review. A gap analysis at the start gives you a realistic date before you commit.
Do you work with foreign manufacturers with no Malaysian office?
Yes. A foreign manufacturer cannot register devices in Malaysia directly — Act 737 requires a locally incorporated authorized representative (AR). We act as AR on an annual retainer: we hold the registrations, maintain the establishment license and handle vigilance reporting on your behalf.

Talk to a regulatory consultant

Tell us what you make or import and where you want to sell it. We will map the approvals you need — and the order to get them in.

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