Post-market support · Southeast Asia
Registration is where the maintenance work begins.
This page covers two things: post-registration change notifications, and post-market surveillance duties such as adverse-event reporting, recalls, periodic reports and renewals. The rules for all five markets are set out from official guidance, with a detailed guide for each country. MediPass holds licences through its own companies in all five markets and submits changes, reports and renewals directly.
Discuss post-market supportSingapore · Malaysia · Thailand · Vietnam · Indonesia
A new model, a revised IFU, a relocated production line, a different sterilisation method: first classify the change in each market, then decide whether it can be implemented before or only after filing.
See post-registration changes →The 48-hour, 10-day and 30-day clocks start when anyone in the company becomes aware. Who reports, to whom and on which form differs by country.
See post-market surveillance →Singapore charges an annual retention fee, Malaysia and Thailand renew every five years, Indonesian validity follows the appointment term. Put every deadline in one calendar.
See service models →Part one
Every regulator tiers its changes: some require a new registration, some need approval before implementation, some can proceed on acknowledgement, on system auto-approval or with a time-limited update afterwards, and some are only recorded in the quality system. Classifying the change comes first; fees, timelines and scheduling follow from it.
The four tiers below are a cross-market reading aid, not a classification shared in law by all five countries; national guidance decides the actual category.
| Country | Framework (current guidance) | Prior approval | No prior approval (conditions) | Official fees | Official timelines |
|---|---|---|---|---|---|
| Singapore | HSA GN-21: Technical (Class C/D), Review (Class B), Administrative and Notification changes; no change notification for Class A | Technical, Review and Administrative changes (GN-21 R7 also places 6Aii/6Aiii listing changes such as added models under prior approval; HSA’s web page still lists them as implementable on acknowledgement, so confirm case by case) | Notification changes: implement on receipt of the SHARE acknowledgement email | Administrative/Review S$560; Technical Class C S$1,890, Class D S$3,120; Notification no fee | Administrative 30, Review 45, Technical Class C 75 / Class D 90 working days (targets from a complete application, excluding stop-clock) |
| Malaysia | MDA/GD/0020: Category 1 new registration, Category 2 evaluation and endorsement, Category 3 notification (MeDC@St 2.0) | Category 2: manufacturing or sterilisation site, materials, contraindications, professional-to-home use and similar | Category 3: implement once complete documents are submitted through MeDC@St (e.g. UI-only software changes, manufacturer name/address, certain labelling changes) | Category 2: Class A RM50 / B RM500 / C RM1,000 / D RM1,500; Category 3 RM30; combined filings add up per category and submission ID | Single submission ID (Category 2 or 3): 30 working days; Categories 2 and 3 combined, or multiple submission IDs: 60 working days (from complete documents) |
| Thailand | 2026 amendment guideline: two levels, “evaluated by an officer or external expert before approval” and “auto-approve”, decided by change type rather than risk class; all filed in Skynet | Evaluated before approval: manufacturing site/process/QMS, design or specification, software, materials, labelling and IFU, adding models to a group (Class 2–4); label text and group additions for Class 1 | Auto-approve: e.g. QMS certificate update or change of certification body, importer/manufacturer site details, removal of models (Class 2–4); overseas manufacturer name/address without relocation, software information for Class 1 | Class 2–4: THB 500 per application (paid after approval); if external expert review is needed, add notification manufacture 19,200 / import 24,000, licence manufacture 24,000 / import 30,000; Class 1 free, THB 15,000 where expert review is needed | No uniform review timeline published |
| Vietnam | Decree 98/2021 (consolidated 08/VBHN-BYT): information updates vs. a new circulation number | Class C/D: cases under Art. 29(1)(b) need a new circulation number (product owner, device type, intended use, an added manufacturing site or product code, and similar); Class A/B: re-declaration under Art. 28(3) | Information updates (holder/manufacturer name or address, packaging specification, warranty facility, labels/IFU that do not change intended use, indications, functions or performance): written notice and portal update within 5 working days for Class A/B (Art. 28(4)) and 10 working days for Class C/D (Art. 32(7)) | No fee for information updates; new Class C/D number VND 6,000,000; Class A declaration VND 1,000,000, Class B VND 3,000,000 (reduced under Circular 64/2025/TT-BTC from 1 Jul 2025 to 31 Dec 2026; confirm against the payment notice) | Standard new number: 30 days from a complete, valid dossier (Art. 32(2); other routes differ); information updates have no approval step |
| Indonesia | 2021 change-management guideline (Pedoman Manajemen Perubahan): new application, change application (number unchanged), notification, QMS record only. Its original basis, Permenkes 62/2017, was revoked by Permenkes 5/2026 (promulgated 4 May 2026); under Art. 124 existing implementing rules continue where they do not conflict | Change application (perubahan): size, packaging, labelling, accessories, authorised representative name/address and similar, issued after evaluation | Notification (pemberitahuan): label changes applied across all products with no safety or performance effect; QMS-record-only changes need no filing | PNBP as billed by the regalkes system | PP 28/2025 Annex II: 16 days for a change |
Fees are the official charges published by each authority and exclude service fees. How combined changes are charged and reviewed differs by country (Malaysia adds fees per category, Singapore applies the most stringent category). This page is an overview: whether a change can be implemented, and when to report, must be confirmed for the specific product against current guidance.
Part two
Singapore, Malaysia and Thailand share the same 48-hour / 10-day / 30-day framework for adverse events, but the reporting party, forms and systems differ. Indonesia applies the same 48-hour / 10-day / 30-day tiers through its 2020 KTD technical guideline. Vietnam sets no uniform hour or day clock, but requires immediate action after an event (suspension, notification, investigation) and reporting under set procedures; this is not licence to delay. Validity and renewal windows differ in every market.
| Country | Adverse-event reporting | FSCA / recall | Periodic reports and records | Validity and renewal |
|---|---|---|---|---|
| Singapore | Registrant, manufacturer, importer and wholesaler each report; serious threat to public health 48 hours, death or serious deterioration 10 days, recurrence that could cause death or serious injury 30 days; final investigation report within 30 days (HP(MD)R reg. 42; Form MDC-ADE-003 by email) | Notify HSA before the FSCA starts (MDRR1); a recall needs at least 24 hours’ notice (reg. 44); the regulations require a report within 21 days of commencement or a longer period HSA allows (regs. 45 and 47, as amended in 2018, no longer contain a 24-hour preliminary report); under GN-10 a preliminary report is due within 24 hours where HSA requests it; 21 days is not a deadline to close the investigation (OSCAR); overseas FSCA on devices registered but not yet supplied (MDRR3): report within 30 days | No periodic reports; distribution records kept for the projected useful life or 2 years after supply, whichever is longer | Registration does not expire; annual retention fee Class B S$39, C S$67, D S$134; dealer’s licence renewed annually at S$1,110 |
| Malaysia | Under GD/0014 the manufacturer or Authorised Representative files with MDA; importers and distributors must alert them immediately and carry their own duties under the 2019 establishment regulations; 48 hours / 10 days / 30 days; investigation report within 30 days (MeDCReSt); since 8 May 2025 incidents occurring outside Malaysia are no longer submitted, but records must be kept and FCA/recall duties are unchanged | Notify MDA before acting (Form 1); FCA report within 30 days of completion (Form 2); FSN per GD/0013 | No periodic reports; complaint-handling and distribution records per GD/0011 and GD/0012 | Registration valid 5 years; re-registration opens within 1 year before expiry in MeDC@St; establishment licence renewal applied for at least 90 days before expiry (GD/0027, 2nd ed.) |
| Thailand | Manufacturers or importers holding a licence, notification or listing report; domestic events (Form ร.ม.พ.1) 48 hours / 10 days / 30 days with follow-ups on the same clocks (HPVC system or adr@fda.moph.go.th) | FSCA in Thailand or abroad (Form ร.ม.พ.3): initial report within 48 hours of awareness; each follow-up or final report within 21 days of the previous one until the action is complete | Semi-annual summary of foreign events and trends (Form ร.ม.พ.2: January–June events within August, July–December events within February of the following year); annual production/import report by 31 May of the following year (B.E. 2568 notification, from 1 Mar 2026; sales reports only for specified devices); records kept 5 years | Licences, notification certificates and listing certificates valid 5 years, renewed before expiry |
| Vietnam | No hour or day clock, but action must be immediate: the holder keeps traceability records and must immediately stop supply, notify and remedy defective devices (Art. 74); events involving a serious threat or death require a website notice, written notice to the MOH and suspension of the batch (Art. 35) | Arts. 34–36: investigate and report within 30 days; MOH decides suspension within 3 working days and lifting within 20 working days of the completion report; three recalled batches under one number lead to revocation, except voluntary recalls by the holder (Art. 38) | No general periodic reports; records under Art. 33 (LOA, CFS, distribution records, test reports, Vietnamese IFU) | Circulation and declaration numbers are valid indefinitely (Art. 21); LOA, CFS and similar must remain valid throughout |
| Indonesia | Holders report KTD through e-watch alkes: serious public-health threat 48 hours, death or serious injury 10 days, events that could cause such harm if repeated 30 days, initial investigation report in 7 days and final report in 30 days (2020 KTD technical guideline III.D–E); Permenkes 5/2026 establishes device vigilance (Art. 103), with new technical guidance to be set by the Minister | The holder recalls on instruction or its own initiative, with records and reports (Permenkes 5/2026 Arts. 85–88); an expired, un-renewed licence is a recall ground (Art. 86) | Periodic reports twice a year (PP 28/2025 Annex II); under Permenkes 5/2026 production/import and potential shortages are reported through SIK; distributor CDB certificate valid 5 years with annual internal audit (PP 28/2025) | Izin edar valid up to 5 years (PP 28/2025 Annex II), renewal filed no later than 9 months before expiry (Permenkes 11/2025 imported-device standard) and processed in 13 days; termination of the distributor appointment or a lapsed business licence can lead to revocation (Permenkes 5/2026 Art. 51) |
Service models
MediPass holds registrant, authorised representative, importer or distributor status through its own companies in all five markets, so change submissions, event reports and renewals are followed by one team and tracked in one internal project register (filings still go through each authority’s own system). The four models below can be engaged separately or combined.
Model 1
One cross-border regulatory calendar: annual retention fees, five-year re-registrations, semi-annual and annual reports, establishment-licence renewals and the impact of guidance updates on your products, listed per product with owners and deadlines.
Model 2
You send one change description; MediPass returns a five-market determination: category, whether prior approval is needed, official fees, timelines and a recommended filing order, then files country by country.
Model 3
One intake point mapped to five systems: the HSA form, MeDCReSt, HPVC, the Vietnam MOH and e-watch alkes. Reporting duties and statutory deadlines are confirmed within the response time agreed in the service contract, and the local licence-holding company files.
Model 4
When changing distributor, taking back a registration or leaving a market: transfer or re-registration by country, re-issued distributor authorisations, handover of complaint and distribution records, stock transition and last-batch import.
Extensions: importer of record with sample and demo-unit imports; outsourced regulatory affairs for distributors (complaint handling, distribution records, GDPMD/CDAKB audit preparation); product withdrawal and cancellation management. Pricing is confirmed by quotation or service contract; the fee structure (service fee, annual holding fee, government fees) and start dates are set out under Fee structure on the licence-holding page.
| Engagement | When it applies and what we need | Deliverables | Boundaries |
|---|---|---|---|
| Ongoing maintenance | Existing registrations; certificates, product list and task history | Regulatory calendar, expiry register, quarterly status list | Whether actual submissions are included is stated in the service contract; government fees are extra |
| Single change or event | A proposed change or an event that has occurred; the before/after difference or known facts | Five-market determination matrix or event record, filing documents, submission receipts | Assessment is not submission; out-of-scope items are confirmed separately |
| Transition project | Changing distributor, taking back a registration or exiting | Country-by-country schedule, handover checklist, confirmation of regulatory effective dates | The outgoing holder’s cooperation affects the route and timing |
No. All five markets separate a change of licence holder from a product change: Singapore uses the GN-24 change of registrant, Malaysia a change of AR, Thailand a transfer, and in Vietnam and Indonesia the new holder re-registers. If models or labels change at the same time, the change category is assessed separately.
It depends on the category: changes needing prior approval are implemented after approval; Singapore Notification changes on receipt of the SHARE acknowledgement e-mail; Malaysia Category 3 once complete documents are submitted; Thai changes on the auto-approve list once the system approves them; Vietnam information updates must be notified within 5 (Class A/B) or 10 (Class C/D) working days of the change; Indonesian QMS-record-only changes need no filing. Technical changes affecting safety or performance need prior approval in all five markets.
The duty sits with the local party: in Singapore every licensed dealer of the device reports, in Malaysia the manufacturer or AR files with MDA (importers and distributors must alert them immediately), in Thailand the licence-holding manufacturer or importer. The overseas manufacturer provides the investigation and judgement; the local licence holder files through the local system.
Malaysia opens re-registration within 1 year before expiry and requires establishment-licence renewal at least 90 days ahead; Thai certificates last 5 years and can be renewed from 90 days before expiry; Singapore charges an annual retention fee; Vietnam’s numbers do not expire; Indonesian licences last up to 5 years and renewal is filed no later than 9 months before expiry. We recommend checking LOA, ISO certificate and CFS validity at least 6 months ahead.
Only the tasks agreed. The service contract states separately what covers monitoring and registers, assessment, document preparation, actual submission and event coordination; additional items are scoped and priced separately.
The target countries, the registration certificates or numbers, the registered product scope, the current licence holder and a short description of the proposed change or event. If information is incomplete, we start with a gap check and then confirm the deliverables.
Tell us the target countries, the product name or registration number, and the change, event or renewal you are dealing with. We reply first with the applicable category, deadline and next step.
Discuss post-market support