AlphaMedic supports MedTech companies entering Asia through regulatory strategy, clinical validation and market access in Hong Kong and Macau. Macau’s new regulatory system (Law No. 12/2025) took effect on 1 July 2026. Class IIb & III require registration by 2028, Class IIa by 2029, Class I by 2031. New updates include import exemptions, Hengqin provisions and a new classification catalogue.
Overview of Macau’s New Regulatory System (Effective 1 July 2026)
Macau has transitioned from a light‑touch system to a full lifecycle regulatory framework, covering:
Registration / filing
Manufacturing
Import / export
Wholesale & retail
Clinical trials
Post‑market surveillance
Quality management
This marks a major shift in Macau’s regulatory maturity and alignment with international standards.
Device Classification (EU‑style)
Macau adopts a four‑tier risk classification:
Class I – Low risk
Class IIa – Medium‑low risk
Class IIb – Medium‑high risk
Class III – High risk
Registration & Filing Requirements
Only registered or filed devices may legally circulate in Macau.
Class I & IIa → Filing (備案)
Class IIb & III → Registration (註冊)
Transition Timeline (Critical for Manufacturers)
Macau has defined a multi‑year transition period as below. Manufacturers must apply at least one year before the deadline to avoid disruption.
Class IIb & III — Registration required by 1 July 2028
Class IIa — Filing required by 1 July 2029
Class I — Filing required by 1 July 2031
Key 2026 Policy Updates
Import Exemption
Low‑risk devices (Class I & IIa) under MOP 5,000 may be exempted for personal use.
Hengqin Cooperation Zone (橫琴)
Devices manufactured in Hengqin may be exempt from foreign approval requirements, creating a simplified pathway.
New Classification Catalogue (2026)
ISAF released a new catalogue aligned with IMDRF categories.
Operator Requirements
New requirements for:
Facilities
Equipment
Technical supervisors
Quality management systems
These apply to manufacturers, importers, distributors and retailers.
Sources:
Law No. 12/2025 — Medical Device Supervision and Administration System
ISAF 2026 Classification Catalogue
Macau Government Official Announcements（2025–2026）
