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Medical Device Consultant.MY
ACT 737 · Mandatory for foreign manufacturers

Your company in Malaysia, without opening a company in Malaysia.

Foreign manufacturers cannot register devices with MDA directly — the law requires a locally incorporated authorized representative. We serve as your independent AR on an annual retainer: registrations held, license maintained, vigilance answered.

Device registration
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
The independent-AR advantage

Keep regulatory custody separate from sales

The AR decision is strategic, not administrative. Whoever holds your Malaysian registrations controls your market access: if that is a distributor and the relationship sours, your products can be stranded mid-tender while registrations are untangled. An independent AR — a consultancy whose only role is regulatory custody — means you can appoint, add or replace distributors as pure commercial decisions.

As your AR, AA Alive Sdn Bhd holds the establishment license and GDPMD certification the role requires, and carries the duty-holder obligations under Act 737 on your behalf.

What the retainer covers

  • Device registrations held in trust — with a contractual transfer path that protects you
  • Establishment license and GDPMD maintained continuously
  • Vigilance contact: complaint intake, mandatory problem reporting to MDA
  • Field safety corrective action and recall coordination with your distributors
  • Renewal calendar for every registration we hold
  • MDA correspondence and inspection support

Pricing

Market entry for a foreign manufacturer is one all-inclusive package: Authorised Representative + Importer + Distributor — RM25,000, covering GDPMD certification (CAB fees included) and the establishment license submission via MeDC@St (MDA fees included). Device registrations are then RM2,500–9,800 per device (CAB and MDA fees included), and the ongoing AR representation runs as an annual retainer scaled to portfolio size and vigilance workload — quoted in the same written proposal. Renewals per the published schedule: GDPMD RM2,500/yr, license RM9,000/3yr, registrations RM6,000/5yr. Payment plans from RM1,500/month — see pricing.

FAQ

Frequently asked questions

Why does a foreign manufacturer need an authorized representative?
Act 737 requires devices from manufacturers with no legal presence in Malaysia to be registered through a locally incorporated authorized representative (AR). The AR holds the device registrations, maintains its own establishment license, and is MDA’s point of contact for vigilance and recalls. No AR, no market access.
Should my distributor be my AR?
It is common — and it is the most frequent regret we see. If your distributor holds your registrations, your registrations are hostage to that commercial relationship: change distributors and you may face re-registration. An independent AR separates regulatory custody from sales, so you can add or replace distributors freely.
What does AR service cost?
Setup is one all-inclusive package: AR + Importer + Distributor at RM25,000, including GDPMD certification with CAB fees and the establishment license submission with MDA fees. Ongoing representation is an annual retainer scaled to your portfolio. Renewals follow the published schedule (GDPMD RM2,500/yr, license RM9,000 every 3 years, registrations RM6,000 every 5 years). Payment plans from RM1,500/month.
What does the AR role include day to day?
Holding your device registrations and the establishment license behind them, maintaining GDPMD certification, acting as the vigilance and mandatory-problem-reporting contact, coordinating recalls, tracking renewal deadlines, and representing you in MDA correspondence. It is a continuing legal role, which is why it is priced as an annual retainer rather than a one-off fee.
Can you take over from our current AR?
Yes. AR transfers are a defined process — we manage the change notifications and re-issuance so supply is not interrupted. Bring the current registration details to the first call and we will map the transfer path.

Selling into Malaysia from abroad?

Tell us your device portfolio and current setup. We will propose the AR structure, the registration sequence and the annual retainer for your case.

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