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HSA Singapore Publishes GN-02 Revision 8 — Updated Licensing Rules for Manufacturers, Importers & Wholesalers (April 2026)

In April 2026, HSA Singapore published Revision 8 of its Guidance Document GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices. The revision refreshes compliance expectations across all device classes (A, B, C, D) and updates the annex templates that licence holders rely on for day-to-day submissions.

This is a compliance-documentation update, not a new licensing regime. But licence holders — and anyone operating under a Manufacturer's Licence (ML), Importer's Licence (IL), or Wholesaler's Licence (WL) issued under the Health Products Act — should review the revision to confirm their internal templates and processes match the updated annex formats.

What GN-02 governs

GN-02 is HSA's primary guidance on dealer licensing for medical devices in Singapore. It covers:

Eligibility criteria for ML / IL / WL
Application requirements and documentation
Responsible person (RP) obligations
Quality Management System (QMS) expectations per licence type
Good Distribution Practice for Medical Devices (GDPMDS) alignment
Renewal, variation, suspension, and revocation
Record-keeping, vigilance, and post-market obligations
Annexes covering declarations, checklists, and templates

Every Singapore-based manufacturer, importer, and wholesaler of medical devices (regardless of Class) operates under at least one of these licences. Revision 8 is the first refresh since the earlier revision cycle closed, so the delta is worth a deliberate read.

What Revision 8 changed

Based on the revision notes published with the April 2026 release, the most material updates are:

The single concrete R8 delta: audit report is now mandatory

The one operational change that will bite compliance teams is straightforward: the certification body's audit report must now be submitted alongside the QMS certificate for every new dealer's licence application and every amendment that touches QMS scope — site addition or removal, device-type change, risk-classification change, scope-of-operations change, cold-chain or secondary-assembly add/remove, certification-body change, certificate validity-date renewal, licence-type change, or UEN change.

In R7, the QMS certificate alone was sufficient. In R8, HSA will request — or refuse to accept — an amendment submission that lacks the audit report. If your certification body issues the audit report as a separate document from the certificate, add it to your standing licence-application evidence bundle before your next submission.

Affected R8 §5.5 footnotes and Annex-2 rows: operating sites address change, device type change, risk classification change, quality systems change, certification body change, QMS certificate validity date, scope of operations change, cold-chain management (add/remove), secondary assembly (add/remove), licence type change, UEN change.

1. Annex updates for QMS declaration

The annexes that licence holders use to declare their QMS coverage during application and renewal have been updated. Organisations should:

Download the current Annex templates directly from HSA (the April 2026 PDF linked below)
Compare against the version currently used in your internal RA system
Flag any changes to required fields, declaration wording, or attachments
Update your submission templates before your next renewal or variation

2. Export / re-export declaration annex changes

Revision 8 updates the annex templates for export and re-export declarations. If your business includes export or re-export flows (for example: an importer that re-exports products to regional distributors, or a wholesaler handling transshipments), confirm your declaration format matches the current Annex. Using an outdated annex will slow down HSA review and may trigger a request for resubmission.

3. Refreshed licensing and compliance pathways

The guidance text has been refreshed to reflect the current regulatory posture across Class A through D devices. The underlying licensing categories remain the same — what has moved is the compliance pathway guidance, cross-references, and terminology alignment with the broader HSA Medical Device regulatory stack (including the recent Software Medical Device and SaMD CMP guidances).

Who this applies to

Every holder — or prospective applicant — of a:

Manufacturer's Licence (ML) — for entities that manufacture medical devices in Singapore
Importer's Licence (IL) — for entities that import medical devices into Singapore for local supply
Wholesaler's Licence (WL) — for entities that supply medical devices in Singapore (wholesale distribution)

This covers the full spectrum: Class A exempt-registration suppliers up through Class D high-risk implantable device manufacturers. The licence obligations scale with class and activity, but the guidance applies horizontally.

What licence holders should do now

Immediate (this week)

Download GN-02-R8 from HSA (PDF link below) and save a dated copy to your regulatory library.
Identify your licence types and confirm which annexes apply to you.
Compare your current submission templates against the new Annex format. If there are field, wording, or attachment differences, schedule a template refresh.

Before your next renewal or variation

Update QMS declaration templates in your quality management system so that renewal submissions use the current Annex version.
Update export / re-export declaration templates if your business does any outbound trade.
Refresh internal training material — any SOP or onboarding reference that names an earlier revision of GN-02 should be updated to GN-02-R8.
Cross-check other HSA guidances your operation relies on (for example GL-04 for software medical devices, GN-37 for SaMD change management) to confirm consistent terminology across your regulatory documentation.

Ongoing

Track HSA guidance updates through a regular scan cadence. Dealer-licensing guidance historically sees a major revision every 2–3 years; annex templates can refresh more frequently in between.

Why this matters even though it's "just" a revision

Dealer-licensing guidance doesn't get headlines the way new SaMD or AI device frameworks do. But it's the paperwork that keeps your business operating. A QMS declaration that cites an outdated annex template is grounds for HSA to return your submission — and if that happens close to a licence expiry, it can trigger an operational pause on product entry, distribution, or manufacturing.

Treat Revision 8 as compliance hygiene: low glamour, high consequence if skipped.

Source

Primary document: GN-02-R8 Guidance on Licensing of MIW (April 2026) (PDF, HSA)
HSA guidance documents index: HSA Medical Device Guidance Documents

Related regMD coverage

This article summarises publicly available HSA guidance for informational purposes and does not substitute for legal or regulatory advice. Always refer to the primary HSA document and consult your Regulatory Affairs adviser for licence-specific decisions.