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

The licence holder foreign makers must appoint

Under the Medical Device Act 2012 (Act 737), a manufacturer with no legal presence in Malaysia cannot register a device or place it on the market by itself. It must appoint a locally incorporated authorized representative (AR) — the entity that holds the MDA establishment licence, lodges the CSDT dossier through MeDC@St, coordinates the CAB conformity assessment, and stands as MDA’s duty-holder for vigilance and recalls. The AR is not paperwork you file once; it is a standing legal role that lives for as long as your devices are on the Malaysian market.

As your AR, AA Alive Sdn Bhd holds the establishment licence and GDPMD certification the role requires, and carries the duty-holder obligations under Act 737 on your behalf. Because we already hold our own licence (MDA-6798-K124) and run the same GDPMD system we build for clients, you are appointing a licensed establishment that exists today — not one still being assembled.

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, with a contractual transfer path that keeps the registrations yours.

It also runs the other way. For a Malaysian manufacturer exporting into the EU, an EU authorized representative is the mirror requirement — a European-based representative the CE marking route depends on. We coordinate that appointment too, so one consultant covers both directions of trade.

What the AR retainer covers

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

Engagement path

1. Scope & structure — we map your portfolio, confirm device classes and set the AR structure, including any transfer from a current AR.
2. Licence & GDPMD — the AR + Importer + Distributor package puts the establishment licence and GDPMD certification in place (or confirms ours already covers you).
3. Register the portfolio — CSDT dossiers, CAB conformity assessment and MeDC@St submission for each device, held under our AR licence.
4. Ongoing representation — vigilance, recalls, renewals and MDA correspondence run on an annual retainer for as long as you sell in Malaysia.

Pricing — published package, recurring role

Market entry is priced as our fee, with the CAB and MDA fees you pay direct listed separately; the ongoing AR role is the recurring layer that keeps your registrations alive.

Ongoing AR representation runs as an annual retainer scaled to portfolio size and vigilance workload — quoted in the same written proposal, not a fixed shelf price. Per-device registration fees above are all-in (CAB and MDA fees inside); for GDPMD and the licences, the CAB and MDA fees are paid direct, as listed. See the full schedule on pricing.

Two rule changes that land on your AR, not on you.

The Singapore reliance route. Since 1 March 2026, Class B–D devices already listed on the Singapore Medical Device Register can clear Malaysian conformity assessment through the Verification Route under MDA/GD/0070. If you sell in Singapore already, your Malaysian entry got cheaper — but the route shortens the dossier review only. It does not waive the AR requirement, because Act 737 still requires a locally incorporated entity to hold the registration. Details on our Verification Route guide.

The import permit. Enforcement moved from 2 January 2026 to 1 July 2027. When it starts, permits are lodged per shipment through ePermit by the licensed importer — which, for most foreign manufacturers, means us. It is one more operational duty that sits with your Malaysian representative rather than with your head office. See the import permit guide.