🇲🇴 Macau medical device regulatory data

Under the new Advertising Law, device advertisements must be filed with ISAF at least 5 working days before publication, with the ad specimen and documents substantiating its content; prohibited content includes efficacy or safety guarantees, claims that the product is necessary for health, and comparison with medicines (unless addressed to healthcare professionals). ISAF monitors device advertising and can impose conservation measures; violations are punishable by advertiser fines of MOP 5,000 to 80,000.

Labels and IFUs must not contain 8 categories of messages: implying no need to consult a doctor or undergo surgery; guaranteeing efficacy or safety; claiming that non-use harms health; quoting organizations, scientists, health technicians or patients; exaggerated or fraudulent cure claims or images; unverified quality/effectiveness/safety content; content offending public morality.

Medical institutions and medical personnel are banned from acting as advertising spokespersons for medical devices (as well as medical services, medicines, health products and milk powder); medical personnel are also banned from promoting devices as live-stream marketers.

Medical device registration is valid for 5 years and renewable for equal periods.

If the holder does not apply for renewal, or renewal is refused, the registration lapses at the end of its validity period. ISAF may suspend a registration for non-compliance, and the holder must correct the causing irregularities within an ISAF-specified period.

Registration renewal must be applied for between 180 and 90 days before expiry; the renewal dossier is a compliance declaration (continued legitimacy, continued conformity, unchanged approved label/IFU), the overseas marketing-authorization document (except designated regions), and an adverse-event monitoring report.

The Pharmaceutical Administration Bureau (ISAF, 藥物監督管理局) is the competent authority: it assembles registration and business-licence dossiers and archives filing materials; the ISAF President decides on registration.

Filing (Class I/IIa) changes require written notice to ISAF at least 5 working days in advance.

Registration-data changes in listed categories (including label/IFU style, holder administrative data, non-substantial improvements and other data not affecting safety or quality) require written notice to ISAF at least 20 working days in advance; other changes require ISAF pre-approval; changing the device name is prohibited and requires a new registration application.

The registration dossier must include clinical evaluation data (and non-clinical evaluation data); safety data from expanded-access use of trial devices in life-threatening conditions without effective treatment can be used to support the registration application.

Conducting a clinical trial of a medical device in Macau requires prior ISAF authorization; before deciding, the ISAF President must obtain a binding opinion of the Life Sciences Ethics Committee.

Medical device means instruments, apparatus, implements, in vitro diagnostic reagents and calibrators, materials and other similar or related articles used directly or indirectly on the human body, including computer software; custom-made devices for specific patients are a defined subcategory.

Filing applications use the same dedicated form and require: legitimacy declaration; criminal-record and tax-clearance documents; optional risk analysis (mandatory for IIa per gov.mo service page); technical requirements; label/IFU samples; overseas marketing-authorization document (except designated regions); patent proof or declaration.

Registration applications use an ISAF dedicated form plus: applicant identity documents, criminal-record certificates and tax-clearance certificate; legitimacy declaration; risk analysis; essential-principles safety and performance checklist; technical requirements; test summary report from the manufacturing plant or a third-party testing institution; clinical evaluation and non-clinical evaluation data; label/IFU samples; manufacturing-site conformity proof (and contract-manufacturing documents); overseas marketing-authorization document for foreign-made devices (except designated regions); optional third-party review report for innovative devices; patent certificate or declaration.

Two applicant categories exist: (a) natural persons domiciled in Macau or legal persons incorporated in Macau that manufacture devices in or outside Macau, directly or through contract manufacturing; (b) importers seeking to place abroad-registered devices on the Macau market, which must hold a Macau import/wholesale licence (medical device operator licence, drug product importer/wholesaler licence, or Chinese medicine import permit). Applicants must have no debts under enforced tax collection.

An operation licence (經營准照) from ISAF is required to import/export and wholesale Class IIb and III devices and to retail Class IIb devices; retail of Class III devices is prohibited.

Manufacturing devices in Macau requires a manufacturing licence (製造准照) from ISAF: the manufacturer must hold an industrial licence for the premises and operate a quality management system conforming to medical device Good Manufacturing Practice; the licence is valid 3 years, renewable for equal periods. Contract manufacturing requires prior ISAF permission.

The operation licence is valid from the issue date to 31 December of the following year and is renewable annually; holders must submit a continuing-compliance declaration every December.

Application fees under the regime must be paid when the application is submitted and are not refunded if the application is not accepted, is refused, or the dossier is archived.

Device labels must carry 13 items: name; model/specification; expiry date (or production date and shelf life); batch/factory number; manufacturer or holder name; origin; performance/main structure/ingredients/intended use; registration or filing number at origin or marketing country; contraindications and warnings; installation/use instructions; maintenance, transport and storage conditions; special safe-use instructions; possible adverse events or side-effect-causing components. Items not on the label must be in the IFU. Class I and II devices need no IFU if they can be used safely for their intended purpose without one.

Labels and instructions for use must be written in at least Chinese, Portuguese or English.

Administrative Regulation No. 11/2026 'Implementing Rules of the Medical Device Supervision and Administration System' (醫療器械監督管理制度施行細則), Official Gazette No. 20/2026 of 2026-05-18 (pp. 25-69), supplements Law 12/2025 with procedural detail: dossiers, labels, review clocks, licences, records.

Law No. 12/2025 'Medical Device Supervision and Administration System' (醫療器械監督管理制度), published in Official Gazette No. 30/2025, is the primary statute; it establishes registration, filing and business-activity licensing for medical devices.

The regime is completed by 4 Chief Executive dispatches (including Dispatch 141/2026 personal-use import amount and Dispatch 142/2026 designated regions), 2 Secretary for Social Affairs and Culture dispatches (including Dispatch 36/2026 classification catalogue) and 26 ISAF technical directives (including 1/ISAF/2026 classification rules, 6/ISAF/2026 nomenclature and label technical requirements, 12/ISAF/2026 filing dossier requirements).

Registration holders and filers must proactively conduct post-market evaluation where scientific or technological change alters the understanding of the device's safety or effectiveness, or where adverse-event monitoring indicates a possible safety defect.

All applications (registration, renewal, changes, filing, licences) must be made on dedicated ISAF-provided forms; gov.mo service pages identify form MD-001 for Class IIb/III registration and MD-005 for Class I/IIa filing, with online submission through the ISAF medical device e-service (app3.isaf.gov.mo/mdws) or in person at ISAF.

During registration ISAF may inspect the applicant's R&D and manufacturing sites and related documents to verify authenticity, consistency, manufacturing conditions and data reliability; applicants must be given at least 10 working days' notice of an inspection, and the date can be changed on reasoned request.

Registration holders and filers must establish and operate product traceability and recall systems and notify ISAF of recalls promptly; ISAF may order recall of all or part of a device batch and temporarily prohibit or restrict manufacture, import/export, wholesale or retail of the device, with sealing, seizure and destruction as last resort.

Only devices registered (Class IIb and III) or filed (Class I and IIa) under Law 12/2025 may circulate in Macau: Class IIb/III go through registration with ISAF; Class I/IIa go through filing (備案) with 5-working-day formal review.

Devices already circulating in Macau before the regime must be registered or filed within transition windows ending 2029-06-30 (Class III and IIb), 2030-06-30 (Class IIa) and 2032-06-30 (Class I).

The statutory registration decision period (70 working days Class IIb, 100 working days Class III) is suspended: (a) from the day ISAF notifies a request for additional information under Art. 10(5) until the documents are submitted; (b) from the day ISAF notifies a deficiency-correction request under Art. 13(5) until correction is completed.

Seven categories of devices are exempt from registration/filing: (1) devices needed for public-health emergencies; (2) devices for research or clinical trials; (3) samples or testing; (4) exhibition display; (5) imports to alleviate shortages; (6) custom-made devices; (7) devices for diagnosis or treatment of a specific patient's special condition, with clinical interpretation by a qualified practitioner and ISAF approval. Categories (1)-(5) and (7) require a special ISAF approval procedure with a dedicated form.

Class I and IIa devices imported solely for personal use with a value not exceeding the amount set by CE dispatch (MOP 5,000 per CE Dispatch 141/2026) are exempt from the import permit required by the External Trade Law (Law 7/2003).

Administrative acts issued under Law 12/2025 (including registration decisions) may be appealed directly to the Administrative Court.

ISAF conducts a formal review of registration applications within 20 working days of receipt; incomplete applications trigger a notification to correct within a specified period, and failure to correct or lack of standing results in non-acceptance; the same correction mechanism applies at substantive review, and the review clock is suspended during correction.

Manufacturing plants must register (in traceable form) import, acquisition, manufacture, export, wholesale, complaints, recalls, returns and destruction of devices, completing entries for import/acquisition/export/wholesale/complaint/recall/return/destruction within 72 hours; IIb/III import-export and wholesale premises must keep equivalent records including stock levels. Records and files are kept for 1 year after the device's use term or expiry date, but not less than 3 years.

ISAF keeps a register of registered medical devices recording: device name, registration number, registration holder name, and registration status.

Registration holders and filers who know or suspect a serious adverse device event must report it to ISAF within 24 hours; a detailed report must be submitted on ISAF demand. Serious adverse event means an event leading or possibly leading to serious harm to bodily integrity or death.