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Medical Device Consultant.MY
PMS · Vigilance · 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, 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
Why a retainer

Compliance that has to happen monthly cannot be bought annually

Every GDPMD and license 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.

What we run for you

  • Complaint intake, register and investigation records
  • Incident triage against mandatory problem reporting criteria — same-day
  • Mandatory problem reports drafted and submitted to MDA
  • Distribution records and lot traceability kept current
  • FSCA / recall procedures tested and ready; full coordination if triggered
  • Periodic PMS summaries for management review and audits

PMS retainers are priced monthly by device portfolio and complaint volume, and slot alongside the published renewal schedule (GDPMD RM2,500/yr, license RM9,000/3yr, registrations RM6,000/5yr). Ask for a scoped quote on WhatsApp.

FAQ

Frequently asked questions

What post-market duties do device companies have in Malaysia?
Registration is the start, not the end. Duty holders under Act 737 must maintain distribution records, handle complaints, investigate incidents, submit mandatory problem reports to 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 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, and recall/FSCA coordination if one is ever needed. You get one consultant who already knows your file.
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 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.

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.

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