ISAF · structured requirements

🇲🇴 Macau IVD regulatory data

Explore the IVD requirements currently available for Macau, organized by topic and linked to official sources.

1 facts1 dimensions1 official sourceslatest verification 2026-09-15

Changes after registration

Common questions about changing a registered IVD in Macau. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Macau approvals and evidence in other markets (1 records)

ChinaHong Kong · Macau

Prior approval / evidence record

Greater Bay Area (GBA) Connect

Name: Greater Bay Area (GBA) Connect
Description: Fast-track for Hong Kong/Macau approved devices
Timeline Reduction: Access to 9 major cities
Eligibility: Hong Kong or Macau approval

医疗器械监督管理条例 (Regulations on the Supervision and Administration of Medical Devices, State Council Order No. 739). Art. 13 puts Class I on filing and Classes II and III on registration; art. 15 completes the filing on submission of conforming materials; art. 18 gives the registering authority 20 working days from receipt of the review opinion to decide NMPA service item — 进口第一类医疗器械备案 (imported Class I device filing): 办件类型即办件, filed 当场 once the materials are complete and in the required form, no fee, and Regulation No. 739 art. 15 obliges publication within 5 working days of receipt NMPA licensing service item — promised acceptance 5 working days, statutory approval clock NMPA service item — device Class III technical review 90 days (Order No. 47 Art. 92)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Prior approvals and evidence for Macau (3 records)

MacauNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

Statement: Law 12/2025 makes prior registration or marketing authorisation in the place of manufacture a legal precondition for registering (Class IIb/III) or filing (Class I/IIa) any foreign-made device in Macau, unless the device is made in a region designated by Chief Executive dispatch (currently the Hengqin Cooperation Zone). An NMPA registration certificate or Class I filing therefore satisfies this documentary prerequisite for Mainland-manufactured devices, but ISAF still conducts its own review of safety, efficacy and quality controllability and issues its own registration certificate; the law creates no Mainland-specific abridged or recognition channel. Separately, Article 12 designates PRC mandatory national standards as an accepted quality standard.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: macau
China Classes In Scope: All classes (I, IIa filing; IIb, III registration); NMPA Class I filing / Class II-III registration certificates satisfy the origin-authorisation prerequisite for Mainland-made devices
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Applies to devices manufactured outside Macau (Art. 9(2))
Exception: devices manufactured in regions designated by Chief Executive dispatch (Hengqin Cooperation Zone per CE Dispatch 142/2026, already held) need not submit the origin registration/marketing-authorisation document
Registration applicant must be a Macau-established entity or a licensed import/wholesale operator (Art. 11)
Registration valid 5 years (Art. 20)
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2026-07-01

Source passage: 二、如屬在外地製造的醫療器械，為在澳門特別行政區註冊或備案，須在外地已註冊或取得銷售許可，但屬公佈於《公報》的行政長官批示訂定的地區製造的醫療器械除外。

MacauEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority: CE Mark (EU MDR)
Accepted: Yes
Benefit: Usable as supporting technical evidence. Administrative Regulation 11/2026 sets the 5, 70 and 100 working-day periods by class, not by origin.
Timeline Savings: None published

Macau AR 11/2026 — registration decision 70/100 working days (Art. 17)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MacauUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence, with no published reduction.
Timeline Savings: None published

Macau AR 11/2026 — registration decision 70/100 working days (Art. 17)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Related structured datasets

Classification systems · 1 record

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

macau:medical-device

Jurisdiction Id

macau

Domains

medical-device
ivd

Name

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

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
iia
Label
Class IIa
Normalized Risk Level
medium
Id
iib
Label
Class IIb
Normalized Risk Level
high
Id
iii
Label
Class III
Normalized Risk Level
highest

Regulator

ISAF

Official Domains

isaf.gov.mo
gov.mo
bo.dsaj.gov.mo

Source Status

official-source-verified

Source Title

Macau PS-2224a — medical device filing/registration service under Law 12/2025

Source Url

https://www.gov.mo/zh-hant/services/ps-2224/ps-2224a

Verified On

2026-08-25

Source Supports

class-axis

Notes

Class IIb and III require ISAF registration; Class I and IIa require filing (備案) with formal review; only registered IIb and filed I/IIa devices may circulate (PS-2224a; Law 12/2025 Art. 17(1)).
Devices are classified per the Macau medical device classification catalogue approved by SSAC Dispatch No. 36/2026.
Risk-based classification rules are set by ISAF technical directive published as Dispatch No. 1/ISAF/2026 《醫療器械分類規則及技術要求》 (Law 12/2025 Art. 6(4)).

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Macau registration →

Country

Macau

Jurisdiction Id

macau

Country Code

Flag

🇲🇴

Regulator

Pharmaceutical Administration Bureau (ISAF)

Regulator Abbrev

ISAF

Region

asia-pacific

Tier

Risk Classification

4-class (I, IIa, IIb, III) — Administrative Regulation 11/2026

Classes

Id
class-i
Class Name
Class I
Risk Level
low
Pathway
Formality review
Official Timeline
Min
5
Max
5
Unit
working-days
Realistic Timeline
Min
1
Max
2
Unit
months
Notes
Administrative Regulation 11/2026: Class I devices file for formality review, completed in 5 working days
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
Macau AR 11/2026 — registration decision 70/100 working days (Art. 17)
Url
https://bo.dsaj.gov.mo/bo/i/2026/20/regadm11_cn.asp
Accessed Date
2026-08-25
Id
class-iia
Class Name
Class IIa
Risk Level
medium
Pathway
Formality review
Official Timeline
Min
5
Max
5
Unit
working-days
Realistic Timeline
Min
1
Max
3
Unit
months
Notes
Administrative Regulation 11/2026: Class IIa devices file for formality review, completed in 5 working days
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
Macau AR 11/2026 — registration decision 70/100 working days (Art. 17)
Url
https://bo.dsaj.gov.mo/bo/i/2026/20/regadm11_cn.asp
Accessed Date
2026-08-25
Id
class-iib
Class Name
Class IIb
Risk Level
high
Pathway
Registration
Official Timeline
Min
70
Max
70
Unit
working-days
Realistic Timeline
Min
4
Max
6
Unit
months
Notes
Administrative Regulation 11/2026: Class IIb registration decided within 70 working days; a one-time 45-working-day extension and stop-clock for sponsor responses may apply
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
Macau AR 11/2026 — registration decision 70/100 working days (Art. 17)
Url
https://bo.dsaj.gov.mo/bo/i/2026/20/regadm11_cn.asp
Accessed Date
2026-08-25
Id
class-iii
Class Name
Class III
Risk Level
highest
Pathway
Registration
Official Timeline
Min
100
Max
100
Unit
working-days
Realistic Timeline
Min
6
Max
9
Unit
months
Notes
Administrative Regulation 11/2026: Class III registration decided within 100 working days; a one-time 45-working-day extension and stop-clock for sponsor responses may apply
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
Macau AR 11/2026 — registration decision 70/100 working days (Art. 17)
Url
https://bo.dsaj.gov.mo/bo/i/2026/20/regadm11_cn.asp
Accessed Date
2026-08-25

Key Requirements

Local Authorized Representative (Macau-registered importer) required for foreign manufacturers
Pre-approval changes decided within 100 working days (+45 extension)
Supplementary documentation windows pause the review clock

Prior Approvals

Authority
CE Mark (EU MDR)
Accepted
Yes
Benefit
Usable as supporting technical evidence. Administrative Regulation 11/2026 sets the 5, 70 and 100 working-day periods by class, not by origin.
Timeline Savings
None published
Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
Usable as supporting technical evidence, with no published reduction.
Timeline Savings
None published

Local Rep Required

Yes

Local Rep Name

Macau Authorized Representative

Mdsap Accepted

Mdsap Benefit

Not accepted

Registration Validity

5 years

Verification Status

official-verified

Official Sources

Title
Macau AR 11/2026 — registration decision 70/100 working days (Art. 17)
Url
https://bo.dsaj.gov.mo/bo/i/2026/20/regadm11_cn.asp
Accessed Date
2026-08-25

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by ISAF. Appoint a Macau Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to ISAF including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
ISAF reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. ISAF may issue questions.
Duration
5 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, ISAF issues Macau market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Macau fees →

Jurisdiction Id

macau

Country

Macau

Country Code

Authority

ISAF

Low Risk Local

Min: 500
Max: 550
Currency: MOP
Per Product: Yes

High Risk Local

Min: 500
Max: 550
Currency: MOP
Per Product: Yes

Details

Id
class-iib-iii-registration-base
Item
Class IIb/III registration - statutory base fee
Currency
MOP
Amount Local
500
Amount Local Formatted
MOP 500
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.gov.mo/en/services/ps-2223/ps-2223a/
Source Title
Macau Class IIb/III medical-device registration
Source Effective Date
2026-07-01
Verified On
2026-08-25
Id
class-iib-iii-first-application-total
Item
Class IIb/III first application including stamp duty
Currency
MOP
Amount Local
550
Amount Local Formatted
MOP 550
Frequency
First application; full amount due at submission
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.gov.mo/en/services/ps-2223/ps-2223a/
Source Title
Macau Class IIb/III medical-device registration
Source Effective Date
2026-07-01
Verified On
2026-08-25
Id
class-iib-iii-registration-renewal
Item
Class IIb/III registration renewal including stamp duty
Currency
MOP
Amount Local
220
Amount Local Formatted
MOP 220
Frequency
Per renewal
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.gov.mo/zh-hant/services/ps-2223/ps-2223b
Source Title
Macau Class IIb/III registration renewal (PS-2223b)
Verified On
2026-08-25
Id
class-i-iia-filing
Item
Class I/IIa filing application (備案)
Currency
MOP
Amount Local
0
Amount Local Formatted
MOP 0
Frequency
Per filing
Notes
The government lists the Class I/IIa filing application as free of charge.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.gov.mo/zh-hant/services/ps-2224/ps-2224a
Source Title
Macau Class I/IIa filing application (PS-2224a): free of charge
Verified On
2026-08-25

Notes

Effective 1 July 2026 for the linked Class IIb/III procedure; fee basis CE Dispatch 144/2026.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Macau Class IIb/III medical-device registration
Url
https://www.gov.mo/en/services/ps-2223/ps-2223a/
Effective Date
2026-07-01
Accessed Date
2026-08-25
Title
Macau Class IIb/III registration renewal (PS-2223b)
Url
https://www.gov.mo/zh-hant/services/ps-2223/ps-2223b
Accessed Date
2026-08-25
Title
Macau Class I/IIa filing application (PS-2224a): free of charge
Url
https://www.gov.mo/zh-hant/services/ps-2224/ps-2224a
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Macau certifications →

Slug

macau

Market

Macau

Confidence

low

Schemes

Id
medical-electrical-evidence
Name
Medical electrical evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
Law 12/2025 Art. 12(2): devices must conform to PRC mandatory national standards, or standards set by ISAF-recognized authorities (or organizations recognized by those authorities), or applicant-proposed standards recognized by ISAF. AR 11/2026 Art. 10(2)(八) requires a device test summary report issued by the manufacturing plant or a third-party testing institution; 26 ISAF technical directives (classification, nomenclature/labelling, dossier requirements, contract manufacturing) took effect 2026-07-01.
Source Binding
unresolved
Id
ctt-homologation-import-use
Name
CTT homologation, import and station licence for radiocommunication equipment
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Covered Radio Or Telecom Equipment
Note
CTT official FAQ (31/12/2024) states the live Lei n.º 21/2024 (Regime jurídico das radiocomunicações) position. FAQ 1: sale in Macau of user-terminal equipment for public terrestrial mobile telecommunications services, including terminals with a satellite-mobile function, needs neither CTT homologation, a commercialisation licence, nor an import licence (Arts. 27 and 32). FAQ 2: use of other radiocommunication equipment needs a CTT network or station licence, those models must be homologated by CTT, and import needs an import licence except the statutory exemptions (Secção II of Lei 21/2024; Despacho do Chefe do Executivo n.º 198/2014 as amended through n.º 64/2024). The CTT homologation procedure (form ALR-1) is limited to a holder of a network or station licence, accepts a sample or a foreign homologation certificate, costs 100 patacas for low-power short-range equipment or 250 patacas otherwise, and is decided in 15 working days. The Boletim Oficial HTML of Lei 21/2024 (bo.io.gov.mo/bo/i/2024/46/lei21.asp) did not resolve on this egress, so article bodies beyond the CTT FAQ quotation are not claimed. Retry condition: a reachable BO expression of Lei 21/2024.
Source Urls
https://telecommunications.ctt.gov.mo/en/Services/FAQ
Source Binding
candidate

Official Sources

Authority
CTT
Topic
FAQ quoting Lei 21/2024 Arts. 27 and 32 and Secção II — mobile-terminal exemption versus other radiocommunication equipment
Url
https://telecommunications.ctt.gov.mo/en/Services/FAQ
Authority
CTT
Topic
homologation procedure ALR-1, fees and 15-working-day clock
Url
https://telecommunications.ctt.gov.mo/pt/Services/ProceduresDetails?alias=homologacao_apply
Authority
Imprensa Oficial
Topic
Law 12/2025 medical device standards article
Url
https://bo.dsaj.gov.mo/bo/i/2025/30/lei12_cn.asp
Authority
Imprensa Oficial
Topic
Administrative Regulation 11/2026 registration dossier test report
Url
https://bo.dsaj.gov.mo/bo/i/2026/20/regadm11_cn.asp
Authority
ISAF
Topic
technical directives effective 2026-07-01
Url
https://www.isaf.gov.mo/post/24517