Macau ISAF Medical Device Registration and Listing: Law 12/2025 Class Guide

Quick answer

Macau SAR now regulates medical devices under Law No. 12/2025 (Medical Devices Supervision and Administration System) and Administrative Regulation No. 11/2026, administered by the Pharmaceutical Administration Bureau (ISAF). Both instruments take effect on 1 July 2026, together with 26 technical instructions published by ISAF to operationalise classification, listing, registration, licensing, and import rules. Under the EU-style risk framework, Class I and Class IIa devices require listing (inscrição) with ISAF, while Class IIb and Class III devices require full registration (registo). Companies must also hold the appropriate medical device manufacturing licence or operation licence (covering import, export, wholesale, and retail activities) before placing devices on the market. Foreign-manufactured devices generally must already be registered or authorised in their country of origin; ISAF has published Chief Executive dispatch orders setting fees and simplified documentation for devices manufactured in Hengqin. Forms and guidance are available at isaf.gov.mo.

Who this applies to

This guide applies to:

• Foreign manufacturers exporting medical devices to Macau SAR
• Local manufacturers producing devices in Macau or in the Hengqin cooperation zone
• Importers, exporters, wholesalers, and retailers of medical devices
• Regulatory affairs teams mapping Hong Kong MDACS, mainland China NMPA, or ASEAN pathways to Macau's new framework
• Healthcare institutions and distributors planning supply chains ahead of the 1 July 2026 effective date

Device scope covers all products falling within the medical device definition under Law 12/2025, classified into Classes I, IIa, IIb, and III following an EU-style rules-based approach described in ISAF's technical instructions.

Legal framework: Law 12/2025 and Administrative Regulation 11/2026

Macau's first dedicated medical device statute, Law No. 12/2025, establishes the Medical Devices Supervision and Administration System. It sets out definitions, classification principles, market-access obligations, licensing requirements, enforcement powers, and the role of ISAF as the competent authority.

Administrative Regulation No. 11/2026 supplements the law with procedural detail on listing, registration, licence applications, document requirements, and administrative fees. ISAF announced that the law, regulation, and 26 accompanying technical instructions will all enter into force on 1 July 2026, giving industry a defined transition window to align quality systems, dossiers, and supply-chain contracts.

The Government of Macau reported the publication of the technical instructions through gov.mo, confirming ISAF's role in translating legislative requirements into operational checklists for applicants. ISAF's own notice at isaf.gov.mo further references Chief Executive (CE) dispatch orders that set fee schedules and special rules — including simplified origin documentation for devices manufactured in Hengqin and a personal-import exemption for certain low-risk devices.

Medical device classification under ISAF

ISAF adopts an EU-style four-class system:

Classification determines whether your device follows the listing or registration pathway and influences dossier depth, review timelines, and post-market obligations. ISAF's technical instructions provide the rules-based criteria — align your internal classification record with those instructions before submitting, and document the rationale in your technical file.

If you already hold EU MDR, Hong Kong MDACS, or mainland China NMPA classifications, use them as a starting point but do not assume automatic equivalence. Macau's instructions may differ on borderline products, software-as-a-medical-device, and combination products.

Listing vs registration: class-by-class requirements

The central market-access distinction under Law 12/2025 is between listing (inscrição) for lower-risk devices and registration (registo) for higher-risk devices:

Listing is not a free pass. ISAF still verifies that submitted information is complete and that the device meets classification and labelling rules. Registration involves substantive evaluation of safety and performance evidence before a device may be supplied commercially.

Personal import exemption (Class I / IIa)

ISAF's published notice references a CE dispatch rule exempting personal-use imports of Class I and IIa devices valued at MOP 5,000 or below from the external trade import licence requirement. This exemption applies to personal import scenarios — not to commercial distribution. Companies supplying devices through retail or wholesale channels must still follow listing/registration and operation-licence rules.

Manufacturing and operation licences

Law 12/2025 separates product market access (listing or registration) from establishment authorisation (licences). Both may be required.

Medical device manufacturing licence

Entities that manufacture medical devices in Macau (or in designated cooperation zones subject to ISAF rules) must hold a medical device manufacturing licence. This licence authorises the production activity itself — it does not replace product listing or registration for each device model you place on the market.

Manufacturing licence applications typically require:

• Quality management system evidence (ISAF technical instructions define acceptable standards)
• Facility and process descriptions
• Responsible technical personnel qualifications
• Product scope aligned with classified devices

Medical device operation licence

Entities engaged in import, export, wholesale, or retail of medical devices must hold a medical device operation licence appropriate to their activity. The operation licence is the commercial gate: without it, you cannot lawfully import devices for distribution or sell them to end users — even if the product itself is already listed or registered.

A single corporate group may need multiple licence types if it both manufactures and imports, or both wholesales and retails. Map each legal entity and each physical site to its licence scope before the July 2026 deadline.

Foreign devices and origin-country authorisation

For devices manufactured outside Macau, Law 12/2025 generally requires proof that the device is registered or otherwise authorised in its jurisdiction of origin before ISAF will list or register it. This mirrors approaches in neighbouring jurisdictions and prevents "regulatory arbitrage" through unaudited markets.

Hengqin-manufactured devices receive simplified origin documentation under the CE dispatch orders referenced by ISAF — reflecting Macau's cooperation with the Guangdong–Macao In-Depth Cooperation Zone in Hengqin. If your supply chain includes Hengqin production, confirm the exact document set against the current dispatch text rather than assuming standard foreign-manufacturer rules apply unchanged.

Document packages for foreign devices typically include:

• Certificate of registration or listing from the origin authority (EU, NMPA, HSA, TGA, etc.)
• Free sale certificate or equivalent where required
• Labelling samples in languages acceptable to ISAF
• Authorisation letter if a local agent submits on the manufacturer's behalf

Step-by-step market access workflow

1. Confirm device scope — Determine whether the product falls under Law 12/2025 and is not excluded (e.g., certain in vitro diagnostics may follow parallel pharmacy rules — verify against technical instructions).
2. Classify the device — Apply ISAF classification rules; document rationale in a classification memo.
3. Verify origin-country status — Obtain registration, listing, or authorisation proof from the manufacturing jurisdiction; apply Hengqin rules if applicable.
4. Identify company roles — Manufacturer, importer, wholesaler, retailer; each role maps to a licence type.
5. Apply for establishment licence(s) — Submit manufacturing and/or operation licence applications via ISAF channels with QMS and facility evidence.
6. Prepare product dossier — Listing dossier (Class I/IIa) or registration dossier (Class IIb/III) per technical instructions.
7. Submit listing or registration — File through ISAF with prescribed forms from isaf.gov.mo/pt/services/download.
8. Await ISAF decision — Listing for I/IIa; substantive review for IIb/III.
9. Import and distribute — Hold valid operation licence; comply with import documentation; maintain post-market obligations.
10. Plan renewals and variations — Track certificate validity and report changes per Administrative Regulation 11/2026.

Decision tree

Will you place a medical device on the Macau market commercially?
├─ No (personal use only) → Check personal-import rules (Class I/IIa ≤ MOP 5,000)
└─ Yes
    ├─ Apply for operation licence (import/wholesale/retail as applicable)
    ├─ Apply for manufacturing licence if you manufacture in Macau/Hengqin
    └─ What class is the device?
        ├─ Class I or IIa → Submit LISTING (inscrição) to ISAF
        └─ Class IIb or III → Submit REGISTRATION (registo) to ISAF
            └─ Foreign device? → Include origin-country authorisation (Hengqin: simplified docs)

Key documents and what they must contain

Download current forms and technical instruction PDFs from the ISAF services portal before preparing submissions — form versions may update before July 2026.

Checklist

• Device confirmed in scope of Law 12/2025
• ISAF class assigned (I / IIa / IIb / III) with documented rationale
• Origin-country registration or authorisation obtained (or Hengqin simplified docs confirmed)
• Manufacturing licence applied for (if manufacturing locally)
• Operation licence applied for (import / export / wholesale / retail as needed)
• Listing dossier prepared (Class I/IIa) OR registration dossier prepared (Class IIb/III)
• Labelling reviewed against ISAF technical instructions
• Fees budgeted per CE dispatch orders
• Supply contracts updated for 1 July 2026 compliance
• Post-market surveillance and adverse-event reporting procedures aligned with ISAF rules

Common pitfalls

1. Treating listing as optional for Class I/IIa — Listing is mandatory before commercial supply, not a voluntary notification.
2. Holding product registration but no operation licence — Product approval and establishment licence are separate gates; both are required.
3. Assuming Hong Kong MDACS listing covers Macau — Macau requires its own ISAF listing or registration from 1 July 2026.
4. Using personal-import exemption for commercial shipments — The MOP 5,000 Class I/IIa rule applies to personal use, not distributor imports.
5. Ignoring Hengqin documentation differences — Simplified origin rules apply only where the CE dispatch criteria are met.
6. Late classification of borderline software devices — SaMD may classify higher than expected; re-run classification before dossier lock.
7. Relying on pre-2026 informal supply practices — Law 12/2025 creates enforceable obligations; plan transition now.

FAQ

When does Macau's medical device law take effect?

Law No. 12/2025, Administrative Regulation No. 11/2026, and ISAF's 26 technical instructions all take effect on 1 July 2026, as announced on gov.mo and isaf.gov.mo.

What is the difference between ISAF listing and registration?

Listing (inscrição) applies to Class I and IIa devices — a lower-burden administrative pathway. Registration (registo) applies to Class IIb and III devices and involves full ISAF technical review of safety and performance evidence.

Do I need an operation licence to import medical devices into Macau?

Yes. Commercial import, export, wholesale, and retail of medical devices requires a medical device operation licence from ISAF, in addition to product listing or registration.

Do foreign manufacturers need origin-country approval before ISAF listing?

Generally, yes. Devices manufactured outside Macau must typically show registration or authorisation in the jurisdiction of origin. Hengqin-manufactured devices follow simplified origin documentation under CE dispatch orders.

Which ISAF class uses listing instead of registration?

Class I and Class IIa use listing. Class IIb and Class III require registration.

Is there a personal import exemption for low-risk devices?

Yes. ISAF references a CE dispatch rule exempting personal-use imports of Class I and IIa devices valued at MOP 5,000 or below from the external trade import licence requirement. Commercial imports still require operation licences and product listing/registration.

Where can I download ISAF application forms?

Forms and technical guidance are published on the ISAF website at https://www.isaf.gov.mo/pt/services/download.

How does Macau's framework relate to Hong Kong MDACS?

Hong Kong and Macau are separate jurisdictions. Hong Kong's MDACS listing does not substitute for ISAF listing or registration. Companies serving both markets need parallel compliance — see related guides on Hong Kong registration and cross-border pathways in our linked articles.

Official sources

• Government of Macau — ISAF publishes 26 technical instructions; Law 12/2025 effective 1 July 2026: https://www.gov.mo/pt/noticias/832950/
• ISAF — Law 12/2025 and Administrative Regulation 11/2026 effective 1 July 2026; CE dispatch orders, fees, Hengqin rules: https://www.isaf.gov.mo/pt/post/24335
• ISAF — Forms and technical guidance downloads: https://www.isaf.gov.mo/pt/services/download