MALAYSIA · MEDICAL DEVICES

Malaysia post-market obligations: MPR, FCA and re-registration

A Malaysian hospital tells its distributor that a Class C patient monitor failed to alarm; the patient was not harmed. The distributor logs the case and plans to raise it with the manufacturer at next month’s review. Two weeks later the same model is recalled in another country, and the Malaysian authorised representative (AR) learns only then that a similar event had occurred locally, after the mandatory problem reporting (MPR) deadline has passed.

Malaysia has no periodic safety report; its post-market regime tests how quickly an organisation reacts to an incident, who reports to MDA, and whether the registration and the establishment licence are renewed inside the correct window.

Who reports to MDA, and where does the importer’s or distributor’s duty end?

Mandatory problem reporting for general medical devices (GMD) and in vitro diagnostic devices (IVD) rests on section 40 of the Medical Device Act 2012 (Act 737) and regulation 5 of the Medical Device (Duties and Obligations of Establishments) Regulations 2019. Under GD/0014 the MPR is normally filed with MDA by the manufacturer or its authorised representative; importers and distributors must alert the manufacturer or AR immediately and carry their own duties as licensed establishments under the 2019 Regulations (complaint handling, records, cooperation with FCAs and recalls), so their role is more than passing messages on. Where several manufacturers’ devices are involved, each files its own report. (Source: MDA/GD/0014 Mandatory Problem Reporting, 1st Ed, 2020-05, §3.3)

The clock starts with the supply chain, not the AR: GD/0014 counts the period from when any establishment personnel, including sales staff, become aware of the incident. If the distribution agreement does not translate “immediately” into an internal deadline, monthly batching of complaints puts the AR in breach. (Source: MDA/GD/0014, 2020-05, §3.4.1)

Which incidents are reportable, and how are 48 hours, 10 days and 30 days allocated?

GD/0014 applies three criteria: an incident occurred, the device is associated with it, and it led, or could lead on recurrence, to death, serious deterioration in health or a serious public health threat; where in doubt, report. The timelines are 48 hours after the establishment becomes aware that an incident is a serious threat to public health; 10 days for an incident that led to death or serious deterioration, or could do so if it recurs; and 30 days for failure, deterioration in effectiveness or inadequate labelling or instructions that did not lead to death or serious deterioration. Incomplete information does not justify delaying the initial report. (Source: MDA/GD/0014, 2020-05, §3.2.1, §3.4.1–3.4.3)

The text of GD/0014 also covers incidents abroad involving devices registered in Malaysia, but on 8 May 2025 MDA announced on MeDCReSt that it no longer accepts incident reports for events occurring outside Malaysia. Such events now need no MPR, but records and traceability must be kept, and FCA and recall duties for devices in Malaysia are unaffected. (Source: MeDCReSt announcement: Discontinuation of Incident Report Submissions for Events Occurring Outside Malaysia, 2025-05-08)

An investigation report (Annex B) is due within 30 days of the initial report, extendable at MDA’s discretion. Reports go online through the Medical Device Centralized Reporting System (MeDCReSt); combination products are reported by email on the MPR form. (Source: MDA/GD/0014, 2020-05, §3.1, §4.3; MDA Mandatory Problem Reporting page, 2023-02-20)

Field corrective action and recall: notify first, or act first?

FCA rests on section 41 of Act 737 and regulation 6 of the 2019 Regulations. GD/0013 requires the manufacturer or AR to notify MDA before initiating the FCA (Annex B Form 1) and to submit an FCA report (Annex B Form 2) within 30 days of completion, or a longer period allowed by MDA, covering the risk analysis, reason, health hazard assessment and actions taken; MDA closes the FCA in writing once satisfied. For imported devices the manufacturer must inform its AR immediately so the AR can act and notify MDA. (Source: MDA/GD/0013 Field Corrective Action, 1st Ed, 2020-06, §3.1–3.2.1)

The field safety notice (FSN) must follow the Annex C elements, go to all supply chain parties on the establishment’s letterhead and be copied to MDA’s designated email address; a foreign manufacturer’s FSN may be forwarded by the AR or distributor with a cover letter. Recall-related FCA follows MDA/GD/0015, Medical Device Recall. “Notify first” does not mean waiting for approval: the notification informs MDA; the action is driven by the manufacturer’s risk assessment. (Source: MDA/GD/0013, 2020-06, §3.3, Annex C; MDA Guidance Document list, 2026-05-22)

With no periodic report, how should complaint handling and distribution records be prepared?

Malaysia has no PSUR-type periodic safety update report and GD/0014 requires no periodic summary, but it defines trend reporting: a significant increase in incidents not normally reportable, expected side effects that shift the risk-benefit balance, or a significant change in the trend of use errors must be reported. MDA has also issued GD/0011, Complaint Handling, and GD/0012, Distribution Records (both June 2020), which set out the procedures and records that make MPR and FCA traceable. (Source: MDA/GD/0014, 2020-05, §2.15, §3.2.3; MDA Guidance Document list, 2026-05-22)

No periodic report does not mean PMS data goes unexamined. GL/08 requires post-market surveillance data at re-registration: ongoing incidents, incidents resolved in the past three years and the last audit date. Once GD/0072 takes effect (with MeDC@St 3.0, date not yet published), PMS and QMS information will also have to be updated through the change management module during the certificate’s validity, and re-registration will not proceed if any item is outdated; for now re-registration follows GL/08. (Source: MDA/GL/08 Re-registration Guideline, 2nd Ed, 2022-09, §5.2.16; MDA/GD/0072, 2026-05, §7)

Registration is valid for five years: how do the window, fees and timelines work?

Registration is valid for five years and must be renewed before the device can continue to be imported, exported or placed on the market. The re-registration button appears in MeDC@St within one year before expiry; Classes B–D first need conformity assessment by a registered conformity assessment body (CAB); re-registration cannot be submitted together with a change notification. Fees are an application fee of Class A RM500, B RM250, C RM500, D RM750 and a registration fee of Class A RM750, B RM1,000, C RM2,000, D RM3,000 and RM5,000 for a device containing a medicinal product; invoices unpaid after 60 days lapse and the application must be resubmitted. The Class A figures of RM500/RM750 are the new rates under the Medical Device (Amendment) Regulations 2025, P.U.(A) 330, applying to new registrations and re-registrations from 1 January 2026; the RM100 in the GL/08 text no longer applies. (Source: MDA/GL/08, 2022-09, §1.3, §4, §6, §7)

MDA’s re-registration FAQ states that turnaround matches initial registration, 30 days for Class A and 60 days for Classes B–D; the registration number is retained; a declaration of no change is required; withdrawal of a recognised-country approval or CE certificate must first go through change notification; a change of risk class requires a new registration. (Source: MDA FAQ for Re-registration, 2026-01-23)

How do establishment licence renewal and the whole compliance calendar fit together?

Establishment licences (manufacturer, AR, importer, distributor) are renewed through MeDC@St, with the application submitted at least 90 days before expiry (GD/0027 2nd Ed §8; section 24 of Act 737 and the MDA renewal web page still say “not later than one year before expiry”, so both readings exist: prepare a year ahead and file no later than 90 days before). ARs, importers and distributors must hold a GDPMD certificate from a registered CAB, manufacturers an ISO 13485 certificate. Under the Fifth Schedule of the MDR 2012 the renewal application fee is RM200 and the renewal licence fee RM2,000 for a manufacturer or AR and RM1,000 for an importer or distributor. The MDA guidance list shows GD/0027 at its Second Edition (23 September 2022). (Source: MDA/GD/0027 Licensing for Establishment, 2nd Ed, 2022, §8; MDA Guidance Document list, 2026-05-22)

For planning, three timelines belong in one calendar: registration expiry minus twelve months opens the re-registration window, with time reserved to clear pending changes first; licence expiry minus 90 days is the renewal deadline (preparation should start months earlier), with the GDPMD certificate kept valid; MPR and FCA are event-driven and need the distributor’s “immediate” escalation written into the contract as hours. Hypothetical scenario: a certificate expires in September 2027, so the window opens in September 2026; a sterilisation site change planned for late 2026 should be endorsed before re-registration is filed, or the two applications block each other.