Regulatory Insights
Stay informed with the latest medical device and cosmetic regulatory updates across ASEAN markets, with practical insights to support your market entry journey.
Thailand Medical Device Standards 2026: The 21 Product Categories and the Standard for Each
Thailand’s 2026 medical device standards notification took effect on 3 November 2026. See the 21 product categories, the standard behind each, and the transition rules.
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Thailand Medical Mask, N95 and Gown Standards: The Accepted Routes in the 2026 Notification
Thailand’s 2026 standards notification lists the ASTM, EN, Chinese and Thai routes accepted for medical face masks, N95 masks, surgical gowns and coveralls.
Thailand Medical Device Standards 2026: The 21 Product Categories and the Standard for Each
Thailand’s 2026 medical device standards notification took effect on 3 November 2026. See the 21 product categories, the standard behind each, and the transition rules.
Indonesia Medical Device Halal Certification: Class A Deferred to 2028 – How Should Manufacturers Prepare?
The halal phase-in period for Class A medical devices in Indonesia now ends on 17 October 2028. Manufacturers should first decide scope from materials, body contact and actual use, then plan certification, evidence and Indonesian registration. This article explains the checks under PP 40, Perpres 6 and Guideline 373.
Singapore–Malaysia Device Reliance 2026: Which Country to Register First
The HSA–MDA reliance programme continues after its pilot. Each country still registers separately: Singapore-to-Malaysia uses CAB verification, Malaysia-to-Singapore needs full CAB assessment.
Singapore HSA Change Notification: GN-21 R7 Categories and Timelines
How GN-21 R7 sorts changes into Technical, Review, Administrative and Notification routes, what needs approval, SGD fees and working-day targets.
Changing Your Singapore Medical Device Registrant: How to Transfer Without Breaking Supply
Changing a Singapore device registrant is more than handing over a certificate: HSA GN-24 R2 documents, the two-month rule, refusals, records and supply.
Indonesia Cosmetics Halal Requirements: Timelines, Foreign Certificates and Market Entry
PP 40/2026 has moved the halal phase-in deadline for cosmetics in Indonesia to 17 October 2028. Learn how foreign halal certificates are recognised and registered, where non-halal products fit, and how halal, BPOM notification and import formalities run separately.
Malaysia automated re-registration 2026: check CN, CAB and updatable documents first
Automated re-registration in Malaysia still depends on licence, CAB and data-consistency conditions. Based on MDA’s October 2026 FAQs, this explains what can be updated directly, what needs a CN first, and how formerly CAB-exempt COVID-19 test kits should prepare.
Thai FDA Recognises Malaysia MDA: Eligibility and Document Checklist
Thai FDA added Malaysia’s MDA to its list of recognised agencies on 6 October 2026. Eligibility conditions, exclusions, the Full CSDT requirement and product consistency checks for using an MDA approval in Thailand.
Malaysia MDA Product Classification Letter: New 5-Year Validity from October 2026
MDA’s October 2026 update introduces five-year validity for new Product Classification Letters. Review the transition rules, renewal conditions and next steps for your Malaysia portfolio.
Singapore HSA Registration Fees and Timelines: Budgeting by Route
Check classification, route eligibility and the number of applications before calculating HSA fees. Official target working days exclude stop-clock time and do not translate directly into a launch date.
Singapore general medical device risk classification: applying GN-13 from intended use to the rules
A product name or an overseas class does not decide the Singapore risk class. Set out intended use, body contact, duration and principle of operation, check each GN-13 rule, and keep the records that support the result.
Singapore COVID-19 IVDs Move to Class C: Submitting After the IVD Cluster
COVID-19 IVDs moving to Class C does not mean every respiratory combination test can share one application. Check use, users and analyte panels first, then classification, grouping and route.
HSA Premarket Submission Checklist 2027: What Singapore Manufacturers Should Prepare
Prepare for HSA’s 2027 completeness checks with a practical review of device scope, reference approvals, current templates and SHARE dossier organisation.
Indonesia Cosmetics Compliance: Ingredient, Labelling and Advertising Checks under BPOM 25/2025 and 18/2024
Review Indonesian cosmetic formulas, packaging and advertising together. Understand BPOM 25/2025 ingredient rules, BPOM 18/2024 Indonesian-language labelling and promotion requirements, and how to re-check notified products and marketing copy.
Singapore SAR Registration Support Initiative: which devices qualify for the evaluation fee waiver?
Unregistered devices supplied through SAR that meet all of Criteria A or B can have their registration evaluation fees waived. Obtain CMB or AMS endorsement, have the supplier submit to HSA by 31 December, then file the registration within one year of eligibility.
Singapore Post-Market Duties: Adverse Events, FSCA, Annual Retention
HSA’s duties for device dealers: 48-hour/10-day/30-day adverse-event clocks, notify-before-acting FSCA and recall rules, OSCAR filings, records and annual fees.
Budgeting Malaysian medical device registration: MDA fees and CAB assessment costs
Start from the number of grouped applications, then budget MDA fees, CAB assessment, documentation and local licence holding separately. Class A fees changed in 2026, so the RM100 on older pages no longer applies.
Vietnam Class A/B declaration vs Class C/D registration: choosing the route
Choosing a Vietnamese filing route starts with the local risk class and the exact product scope, then the Class C/D case: fast track, standard or other devices. We compare authorities, dossiers and statutory time limits, with a worked hypothetical.
Indonesia AKL Registration: Aligning the Authorisation Letter, Certificates and Models
An AKL dossier works when the local holder, authorisation letter, certificates, models and technical file cover the same product scope. A checking sequence under Permenkes 5/2026 and current rules, including how LoA termination, OEM and packaging differences affect the evidence.
Indonesia’s new SaMD and AI medical device guideline: which products need local clinical validation?
Indonesia’s new guideline covers standalone software, software in devices and AI with a medical purpose. Define the intended use first, then assess local clinical validation and evidence; the parallel route does not waive clinical and performance data.
Singapore Cosmetic Notification Maintenance: Validity, Variants and Product Changes
A Singapore cosmetic notification is valid for one year and must be renewed annually to keep selling. Learn how new shades, fragrances and pack sizes are handled, and which company, manufacturer, formula and name changes need a new notification.
Who Must Notify Cosmetics in Singapore? Importers, Distributors and Overseas Brands
No Singapore company yet? Learn who must submit the HSA cosmetic notification, how importers, freight forwarders and distributors differ, and how to supply several local channels compliantly.
Vietnam Medical Device Registration Now Accepts Apostilles: What Manufacturers Need to Know
Vietnam’s apostille framework took effect on 11 September 2026. Check what it means for CFS, authorization documents, translations and registration dossier preparation.
Indonesia Medical Device Regulation 2026: Key Changes Under MoH Regulation No. 5/2026
Permenkes No. 5/2026 connects medical device registration with import, distribution, domestic-content policy and ongoing reporting. Here is what overseas manufacturers should plan before entering Indonesia.
Thai medical device licence expiry and cessation stock reporting: how the 30, 60 and 15 days apply
Thailand’s stock rules depend on whether an establishment registration, product certificate or sale licence is ending. The 30-day reports, 60-day disposal period and 15-day follow-up report have different conditions; the 60 days are not a general sell-off period for every expired product.
Thailand medical device submission types and CSDT requirements: from risk class to document list
The risk class decides between Listing, Notification and Licence; the Full CSDT, Abridged or reliance route decides what goes in the dossier. Two Class 2 products can still need very different files.
Thailand Medical Device Labelling Requirements 2026: What Manufacturers Need to Change
Thailand’s updated labelling rules cover language, electronic IFUs and software medical devices. See what overseas manufacturers should review and how the two-year transition applies.
HSA Pre-market Consultation (PMC): Development and Pre-submission Guide
Learn when development-stage and pre-submission consultations apply, what to prepare for booking and the HSA fees, and how MediPass helps with question preparation, meeting coordination and follow-up.
Thailand IVD combination panels and model variants: when to split applications
Start from each catalogue number and its intended use, then check the Thai grouping conditions and the 2026 IVD checklists. Similar panels, a shared housing or a common platform do not by themselves decide how many applications you need.
Malaysia post-market obligations: MPR, FCA and re-registration
MDA mandatory problem reporting at 48 hours, 10 and 30 days, distributor escalation, FCA notification and reports, and the re-registration and licence windows.
Malaysia change notification: MDA GD/0020 categories and GD/0072
MDA GD/0020 Category 1/2/3 changes, RM fees and 30/60 working-day timelines, and what GD/0072’s significant/non-significant model changes with MeDC@St 3.0.
Vietnam Decree 90/2026: Medical Device Penalties for Licence Holders and Importers
Decree 90/2026, in force from 15 May 2026, covers device classification, circulation, import, Vietnamese IFU and traceability in Articles 71–80. Chapter II fines are for individuals; organisations pay double.
Vietnam Cosmetic Notification Validity and Changes: What to Maintain After Notification
How long is a Vietnam cosmetic notification receipt valid, and what happens when the brand, formula, responsible company or importer changes? Covers re-notification, supplementary changes, PIF retention, post-market duties and the draft decree.
Indonesia IVD Grouping: Which Products Can Share One Application?
A shared brand, platform or box does not settle how many IVD applications Indonesia needs. How Famili, Tes Kit DIV and Sistem DIV apply to panel tests, models, self-test versions and post-approval additions.
Indonesia Post-Market Duties: e-report, e-watch and Izin Edar Renewal
After Permenkes 5/2026 revoked 62/2017: revocation risk, renewal no later than 9 months before expiry, twice-yearly reports, KTD reporting within 48 hours/10 days/30 days, and expiry as a recall ground.
Indonesia Medical Device Changes: The Four Perubahan Izin Edar Routes
How Indonesia sorts post-registration changes into new application, perubahan, pemberitahuan or QMS documentation, and what applies after Permenkes 5/2026 revoked 62/2017.
Indonesia Medical Device Distributor Change: New Application and Old Stock Transition Rules
Changing a device distributor in Indonesia usually needs a new Izin Edar. Same-NIB renames, revocation grounds, six-month sell-off and shortage reporting.
Thailand Medical Device Amendments: 2026 Guideline, Fees and System
The Thai FDA 2026 amendment guideline: evaluated-before-approval versus auto-approve by change type, non-amendable cases, THB 500 and conditional expert fees, and Skynet filing.
Changing the Registration Holder in Vietnam: Re-Filing Routes and Supply Transition
A Vietnam change of registration holder is not a company rename. We cover product owner vs holder, A/B and C/D re-filing, priority processing and stock risk.
Vietnam Medical Device Post-Market Duties: Events, Recalls, Records
Decree 98/2021 Articles 33–39a and 74: the 30-day investigation after a warning, MOH 3/20 working-day decisions, three-recall revocation (voluntary recalls excepted), indefinite validity, and no annual report for ordinary devices.
Vietnam Medical Device Changes under Decree 98: Notify or Re-register
How Articles 28, 29 and 32 of Decree 98/2021 split changes: 5/10 working-day notice lists, triggers for a new circulation number, the 30-day review and fees.
Vietnam’s six medical device procurement groups from 2027: which can an NMPA approval support?
Circular 57/2025 puts China’s central-level NMPA on the reference list for Vietnam’s medical device procurement groups, but a foreign approval only covers the quality criterion. Manufacturers must also match the user unit’s chosen reference market, standards and form of evidence, with the Vietnamese marketing number holder organising the file.
Changing Your Medical Device AR in Malaysia: How Does MDA Transfer Work and What Comes With It?
How to change your medical device AR in Malaysia via MDA Change of Ownership: three-party documents, RM500 per-ID fee, validity and an uncooperative old AR.
Thailand Cosmetic Labelling and Claims: What to Check Before Printing and Distribution
What should be checked before printing cosmetic packaging for Thailand? Covers mandatory Thai label information, small packs and nano labelling, the 30-day relabelling rule after import, and how to review names, images and efficacy claims.
Importing Cosmetics into Thailand: Notification, Premises and License per Invoice
How should overseas brands arrange cosmetic notification, import and storage premises, a License per Invoice for each shipment and Thai labels? A practical split of brand, importer and distributor responsibilities.
Can multiple models go in one Malaysian application? How to group or split
The number of models does not decide the number of applications. Check proprietary name, manufacturer, intended use, design and permissible variants, then map configurations, labels and evidence into a grouping plan you can submit.
Importing Cosmetics into Indonesia: BPOM Notification Holders, Authorised Importers and SKI
A BPOM notification number is not the end of the process. Learn how notification holders, authorised importers and distributors work together, what SKI batch documents to check, and what to agree before appointing partners.
How to Prepare an ASEAN Cosmetic PIF: Four Parts, Formula Confidentiality and Local Responsibilities
An ASEAN cosmetic PIF is more than test reports. Organise administrative, ingredient, finished-product and safety and efficacy data in four parts, find gaps in manufacturer files, and plan confidentiality, local access and version control.
Malaysia Cosmetic CNH and Importer Arrangements: Authorisation, Distributor Changes and Renewals
Must a Malaysian cosmetic notification holder (CNH) also be the importer? Learn about brand authorisation, multiple designated importers, Type 1 and Type 2 changes, PIF duties and two-year renewals.
Is One Cosmetic Notification Valid Across ASEAN? What the ACD Harmonises and What Remains National
One ASEAN cosmetic notification does not cover five markets. Learn what the ACD harmonises, how local responsibility, validity and import arrangements differ in Singapore, Malaysia, Thailand, Vietnam and Indonesia, and how to sequence multi-country launches.
Vietnam Cosmetic Notification Documents: Responsible Entity, Letter of Authorisation and CFS
Preparing a Vietnam cosmetic notification? Confirm the local responsible entity, then check the letter of authorisation, CFS and exemptions. Covers Circular 34/2025 changes to forms, signatures, product grouping and responses to queries.
Thailand Adverse Event and FSCA Reporting: Deadlines and Renewal
Thai holders report adverse events and FSCAs on ร.ม.พ.1/2/3 (48 h/10 d/30 d, follow-ups within 21 days of the previous report), keep records 5 years, file annual reports by 31 May of the following year (B.E. 2568) and renew every 5 years.
Thailand Medical Device Transfer Guide: Thai FDA Transfer Conditions, Documents and Handover
Can a Thailand medical device change of licence holder use Thai FDA Transfer? Full CSDT vs Partial dossiers, original holder consent and the 30-day duty.
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