ISAF market access

Macau medical device registration resources

Research ISAF registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Macau medical device resource.

9 free resources24/25 requirements covered4 regulations trackedAug 2026 fees reviewed

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Medical device registration database

Search official ISAF device registration records.

Medical device regulations

Browse official ISAF regulations and guidance documents.

AI medical device classifier

Describe your device and get a preliminary ISAF risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Macau requirements.

AI similar registered product finder

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Medical device regulation news

Follow recent Pharmaceutical Administration Bureau (ISAF) policy, guidance, safety, and compliance updates.

Government registration fees

Review current ISAF medical-device registration charges.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

Compare official and realistic ISAF approval times by device class and pathway.

Structured regulatory requirements

Explore all 40 source-linked facts →

24 of 25 research dimensions currently covered · 11 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified

Competent authority: 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 Presiden…

1 source-linked fact

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Primary legislation: 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 a…
Implementing regulation: 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 6…

3 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Device definition and scope: 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 hum…

1 source-linked fact

Checked 2026-08-25

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D04

Classification rules

Verified

Risk classes I, IIa, IIb and III (Law 12/2025 medical device supervision regime).: Class I, Class IIa, Class IIb, Class III

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Market-access route by class: 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 fili…
Transition deadlines for circulating devices: 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 (Cl…

2 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

Foreign registration prerequisite: Foreign manufactured devices must already be registered or hold marketing authorization in the country/region of origin or of first marketing in order to be registered or filed in Macau, un…
Hengqin designated-region exemption: Devices manufactured in the Hengqin Guangdong Macao Intensive Cooperation Zone are exempt from submitting the registration or marketing authorization document issued by the origin authority…

2 source-linked facts

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Registration applicant eligibility: 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 manu…

1 source-linked fact

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Business (operation) licence scope: 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 licence: 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 c…

3 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Registration dossier requirements: Registration applications use an ISAF dedicated form plus: applicant identity documents, criminal record certificates and tax clearance certificate; legitimacy declaration; risk analysis; e…
Filing (Class I/IIa) dossier requirements: 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 servic…

2 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Official forms and electronic submission: 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 a…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Label and IFU language: Labels and instructions for use must be written in at least Chinese, Portuguese or English.
Label content requirements and IFU exemption: 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 st…

2 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

Pre-registration site inspections: 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; ap…

1 source-linked fact

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

Medical electrical evidence: Electrical safety
CTT homologation, import and station licence for radiocommunication equipment: Wireless / radio

2 maintained overlays

Checked 2026-09-07

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D14

Fees

Verified

Class IIb/III registration - statutory base fee: MOP 500
Class IIb/III first application including stamp duty: MOP 550

4 maintained fee lines · 1 related fact

Checked 2026-08-25

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D15

Review clocks

Verified

Class I · Formality review: 5 working days
Class IIa · Formality review: 5 working days
Class IIb · Registration: 70 working days

4 maintained pathways · 1 related fact

Checked 2026-08-30

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D16

Approval validity & renewal

Verified

Registration validity: Medical device registration is valid for 5 years and renewable for equal periods.
Lapse and suspension: 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 holde…

3 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Registration change control: 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 w…
Filing change control: Filing (Class I/IIa) changes require written notice to ISAF at least 5 working days in advance.

2 source-linked facts

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Public register of registered devices: ISAF keeps a register of registered medical devices recording: device name, registration number, registration holder name, and registration status.
Traceability records and retention: Manufacturing plants must register (in traceable form) import, acquisition, manufacture, export, wholesale, complaints, recalls, returns and destruction of devices, completing entries for i…

2 source-linked facts

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical trial pre-authorization: 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 Com…
Clinical evaluation evidence requirement: 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 witho…

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Exemptions from registration and filing: 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) e…
Personal-use import exemption: 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 requ…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Mandatory post-market evaluation triggers: 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…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Serious adverse-event 24-hour reporting: 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 advers…

1 source-linked fact

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Recall duty and ISAF preventive powers: 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 batc…

1 source-linked fact

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Prohibited label and IFU claims: 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; quot…
Device advertising filing and content restrictions: 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; prohi…

3 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Formal review and deficiency correction: 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 failur…
Direct appeal to Administrative Court: Administrative acts issued under Law 12/2025 (including registration decisions) may be appealed directly to the Administrative Court.

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (4 lines) →

ISAF registration fees in MOP · reviewed 2026-08-25

Fee line	Amount	Provenance
Class IIb/III registration - statutory base fee	MOP 500	Verified
Class IIb/III first application including stamp duty	MOP 550	Verified
Class IIb/III registration renewal including stamp duty	MOP 220	Verified
Class I/IIa filing application (備案)	MOP 0	Verified

Registration timeline

Full registration timeline →

Pharmaceutical Administration Bureau (ISAF) (ISAF) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — Administrative Regulation 11/2026 classification

Class / pathway	Review clock	Planning total	Provenance
Class I(Formality review)	5 working days	1-2 months	Verified
Class IIa(Formality review)	5 working days	1-3 months	Verified
Class IIb(Registration)	70 working days	4-6 months	Verified
Class III(Registration)	100 working days	6-9 months	Verified