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AA Alive Sdn Bhd · SSM 1204108-DMDA-licensed practiceSuperbrands Malaysia 2025100+ devices registered
Medical Device Consultant.MY
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PMS · Vigilance · Act 737 duty-holder obligations

Post-market surveillance, run as a service.

The obligations that start after approval are the ones that revoke approvals when neglected. Our PMS retainer keeps complaints, vigilance reporting, distribution records and recall readiness handled every month — audit-ready always.

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

Registration ends. The obligation doesn’t.

Post-market surveillance (PMS) is the set of duties that continue for as long as a device stays on the Malaysian market — after it is registered with the MDA and your business is licensed to trade it. Under the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012, the establishment holding the registration and licence must keep watching the device in real-world use, capture what goes wrong, and act on it — not once a year, but continuously.

In practice that means five things the MDA and your GDPMD auditors expect to see running: complaint handling, distribution records and lot traceability (increasingly tied to UDI — unique device identification), Mandatory Problem Reporting (MPR) of adverse events and incidents to the MDA, and Field Safety Corrective Actions (FSCA) or recalls when a safety issue emerges. The registration holder — or, for a foreign manufacturer, the authorized representative — is the MDA’s vigilance point of contact for all of it.

AA Alive’s own medical-device warehouse in Batu Caves, stacked with boxed devices
Distribution records and lot traceability are lived in the warehouse, not just filed — the foundation of every recall you might have to run.
Why a retainer

Compliance that has to happen monthly cannot be bought annually

Every GDPMD and licence audit asks the same questions: where are your complaint records, can you trace this lot to its customers, who decided this incident was not reportable — and on what criteria? Companies that treat these as audit-week paperwork fail them; companies that run them monthly barely notice the audit.

PMS-as-a-service is our answer: a fixed monthly retainer under which we operate the post-market system with your team — the same consultant, month after month, who already knows your devices, your distributors and your history. It pairs naturally with the AR retainer for foreign manufacturers and the GDPMD monthly plan for local distributors, and folds cleanly into a manufacturer’s existing ISO 13485 quality system where one is in place.

What we run for you

  • Complaint intake, register and investigation records
  • Incident triage against mandatory problem reporting criteria — same-day
  • Mandatory problem reports (MPR) drafted and submitted to the MDA
  • Distribution records and lot traceability kept current (UDI-ready)
  • FSCA / recall procedures tested and ready; full coordination if triggered
  • Periodic PMS summaries for management review and audits
Consultants reviewing medical-device submission documents at a meeting table
Reviewing complaint and vigilance records against MDA reporting criteria — the judgement call an auditor will ask you to defend.

How the engagement runs

  1. PMS review — we assess your existing complaint, traceability and reporting procedures against your Act 737 duties; you receive a findings report and a scoped monthly quote.
  2. System build or repair — procedures, complaint and distribution registers, MPR templates and a tested FSCA/recall SOP, tailored to your portfolio and trained into your team.
  3. Monthly operation — we run the registers, triage incidents the day they surface, draft and submit any mandatory problem reports, and keep distribution and lot traceability current.
  4. Audit & review support — periodic PMS summaries for management review, and we stand with you at GDPMD surveillance audits and licence renewals so the evidence is already there when the auditor asks.

What a PMS retainer costs

PMS is an ongoing obligation, so it is priced as an ongoing retainer — a fixed monthly fee scoped to your device portfolio, complaint volume and number of distributors, not a one-off project fee. Because scope varies this much between a single-product distributor and a multi-brand importer, PMS retainers are quoted separately rather than list-priced.

The retainer slots alongside the published, all-inclusive renewal schedule that keeps the rest of your file alive — GDPMD / ISO 13485 certificate RM2,500/yr, establishment licence RM9,000 every 3 years and product registration RM6,000 every 5 years — all held on one calendar for you. See the full pricing schedule for the market-entry and renewal figures; we add your PMS retainer as a scoped monthly line.

Get a scoped PMS quote
Jawapan ringkas · Bahasa Malaysia

Apakah kewajipan pengawasan pasca-pasaran (PMS) di bawah Akta Peranti Perubatan?

Selepas peranti didaftarkan dengan MDA di bawah Akta Peranti Perubatan 2012 (Akta 737), pemegang pendaftaran, pengimport, pengedar dan wakil sah wajib meneruskan pengawasan pasca-pasaran: mengendalikan aduan, menyimpan rekod pengedaran dan kemampuan surih lot, serta melaporkan kejadian buruk kepada MDA melalui Laporan Masalah Mandatori (MPR) dalam tempoh yang ditetapkan. Kewajipan ini termasuk tindakan pembetulan keselamatan lapangan (FSCA) dan penarikan balik (recall) apabila perlu, dan ia berjalan selagi peranti berada di pasaran. Retainer PMS bulanan kami menjalankan sistem ini bersama pasukan anda supaya sentiasa sedia diaudit — WhatsApp 010-206 2070 untuk sebut harga.

Who runs your file

A named consultant who already knows your devices

Regulatory consulting is an unregulated trade — anyone can print the title on a card. The person who triages your incidents and signs off your reports to the MDA is named here, with a LinkedIn profile you can check.

AA Alive’s medical-device regulatory team
AA Alive’s device regulatory team, on client visits across Malaysia.
Founder & Managing Director · Regulatory authority

Evin Lim

Advises from the operator’s chair — the group registers, imports and supplies devices itself — and speaks on the Malaysian pharmaceutical and device industry on BERNAMA TV and RTM.

LinkedIn profile
Commercial Lead · Your first contact

Lim Yen Thong

Your first point of contact for scope, timelines and quotations. Lim Yen Thong runs the commercial side of the device practice and coordinates every engagement from first enquiry to signed proposal.

LinkedIn profile
FAQ

Frequently asked questions

What post-market duties do device companies have in Malaysia?
Registration is the start, not the end. Duty holders under the Medical Device Act 2012 (Act 737) must maintain distribution records and lot traceability, handle complaints, investigate incidents, submit mandatory problem reports to the MDA within defined timelines, and be able to execute field safety corrective actions and recalls. These duties run continuously for as long as the device is on the Malaysian market.
What does the PMS retainer include?
A working PMS system (procedures, registers, report templates), monthly upkeep of complaint and distribution records, incident triage against reporting criteria, drafting and submission of mandatory problem reports to the MDA, and recall/FSCA coordination if one is ever needed. You get one consultant who already knows your file, your devices and your distributors.
Who is legally responsible for post-market surveillance — us or the manufacturer?
Under Act 737 the duty sits with the local establishment that holds the registration and the establishment licence — the manufacturer if it is local, otherwise the authorized representative, alongside the importer and distributor for the records in their control. For a foreign manufacturer, the AR is the MDA’s vigilance contact, which is why PMS and the authorized-representative retainer are usually run together.
We have never had a complaint — do we still need PMS?
Yes, and empty registers are their own risk: at surveillance audits, “no complaints ever” without a functioning intake process reads as “no complaint system”, not “no complaints”. A light-touch retainer keeps the system demonstrably alive at low cost.
How fast must incidents be reported to the MDA?
Mandatory problem reporting timelines depend on severity — the most serious events carry the shortest deadlines, measured in days. The practical implication: triage cannot wait for a quarterly meeting. Our retainer includes an incident line so triage happens the day you hear about the event.
What is an FSCA or recall, and would you run it for us?
A Field Safety Corrective Action (FSCA) is any action taken to reduce a risk linked to a device already on the market — a recall, a field correction, or a safety notice to users — and it is notifiable to the MDA. Yes: our retainer keeps the recall procedure tested, and if one is ever triggered we coordinate the MDA notification, reconcile affected lots against your distribution records, and manage the close-out.
Does post-market surveillance affect our GDPMD certificate or licence renewal?
Directly. GDPMD surveillance audits and establishment-licence renewals check that complaint handling, traceability and reporting are actually running — a dormant PMS system is a common nonconformity. Running PMS monthly means the evidence already exists when the auditor asks. We keep it on the same renewal calendar (GDPMD/ISO 13485 RM2,500/yr, establishment licence RM9,000 every 3 years, product registration RM6,000 every 5 years) so nothing quietly lapses.

When did someone last check your complaint register?

If the honest answer is 'before the last audit', a monthly retainer costs less than the finding it prevents — and far less than a recall run without a system behind it.

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