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Medical Device Consultant.MY
GDPMD · Condition of the MDA establishment license

GDPMD certification without the drama.

Good Distribution Practice for Medical Devices is the quality system every importer, distributor and authorized representative must hold. We take you from gap analysis to CAB certificate — then keep it alive year after year.

ISO 13485 vs GDPMD
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
What GDPMD is

The license behind the license

GDPMD is Malaysia's quality-system requirement for the distribution side of the device industry. Without a valid GDPMD certificate from a registered CAB, MDA will not grant — or renew — the establishment license an importer, distributor or authorized representative needs to operate. In practice it covers the disciplines regulators care about most: supplier and customer traceability, storage and transport controls, installation and servicing records, complaint handling, and recall readiness.

Our GDPMD practice has run since 2016 under AA Alive Sdn Bhd. We write the system around how your operation actually works — a wholesaler with one warehouse should not carry the paperwork of a multi-site cold-chain operation.

Engagement path

  1. Gap analysis — on-site or remote review of your current operation against GDPMD requirements; you receive a findings report and a fixed package quote.
  2. System build — quality manual, SOPs, forms and records tailored to your operation, with your team trained on each procedure.
  3. Implementation & internal audit — the system runs long enough to generate real records; we internal-audit it the way the CAB will.
  4. CAB certification audit — we manage the audit, sit in the room (or on the call), and close any findings.

Packages — all-inclusive, CAB fees inside

CERTIFICATE ONLY

GDPMD certification

RM10,000
  • Gap analysis & findings report
  • Full documentation build + training
  • CAB certification audit — CAB fees included
Get GDPMD certified
CERT + LICENSE

Importer + Distributor package

RM18,000
  • Everything in GDPMD certification
  • Establishment license via MeDC@St — MDA fees included
  • Payment plans from RM1,500/month
Start this package
RECURRING

Annual renewal

RM2,500/year
  • Document preparation — CAB fees included
  • Surveillance-audit preparation
  • Renewal calendar management
Keep my certificate alive

Foreign manufacturer? The Authorised Representative + Importer + Distributor package (RM25,000) licenses all three roles in one program — see AR services and pricing.

Jawapan ringkas · Bahasa Malaysia

Apakah GDPMD dan berapa kosnya?

GDPMD (Good Distribution Practice for Medical Devices) ialah sistem kualiti yang wajib bagi pengimport, pengedar dan wakil sah peranti perubatan di Malaysia — ia syarat untuk lesen establishmen MDA. Pakej pensijilan kami RM10,000 (sudah termasuk fi CAB), atau RM18,000 bersama lesen establishmen (termasuk fi MDA). Pembaharuan tahunan RM2,500. Pelan bayaran dari RM1,500 sebulan.

FAQ

Frequently asked questions

Who needs GDPMD in Malaysia?
Importers, distributors and authorized representatives of medical devices must be certified to Good Distribution Practice for Medical Devices (GDPMD) as a condition of the MDA establishment license. Manufacturers implement ISO 13485 instead — see our ISO 13485 vs GDPMD comparison.
How long does GDPMD certification take?
A focused SME engagement typically runs a few months from gap analysis to CAB certification audit, driven mostly by how quickly your team adopts the procedures and closes gaps. We set the plan at the gap-analysis stage so the audit date is realistic, not aspirational.
What does GDPMD certification cost?
RM10,000 all-inclusive — our professional work plus the CAB certification fees. Most companies bundle it with establishment licensing: Importer + Distributor package RM18,000, or Authorised Representative + Importer + Distributor RM25,000 (both including GDPMD with CAB fees and the MeDC@St license submission with MDA fees). Payment plans from RM1,500/month.
What happens after certification?
GDPMD certificates renew annually — RM2,500 per year all-inclusive (document preparation and CAB fees). We hold the renewal calendar for every client, alongside the establishment license (RM9,000 every 3 years) and product registrations (RM6,000 every 5 years), so nothing quietly lapses.
Can you fix a failed or lapsed GDPMD audit?
Yes — remediation is a common entry point. We triage the nonconformities, rebuild the affected procedures and records, and manage the follow-up audit with the CAB.

Start with a gap analysis

One visit tells you exactly how far you are from certification — and which package fits your operation. RM10,000 all-in, CAB fees included.

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