Business Licence and the One-Stop Licensing Procedure in Macao

1. Key takeaways

The mandatory nature of the business licence is risk-tiered: import, export and wholesale of Class I and Class IIa devices do not require a business licence; import, export and wholesale of Class IIb and Class III devices require a business licence; retail of Class IIb devices requires a business licence, and retail of Class III devices is prohibited (Article 37 and the official promotional materials). A business licence is valid from the date of issue until 31 December of the following year, and must be renewed annually thereafter. The implementing rules establish a one-stop licensing procedure for the business licence, with participating entities including the Land and Public Works Bureau, the Fire Services Bureau, the Labour Affairs Bureau and the Cultural Affairs Bureau.

• Class I and Class IIa import, export and wholesale fall outside the business licence requirement.
• Class IIb and Class III import, export and wholesale require a business licence.
• Class IIb retail requires a business licence; Class III retail is prohibited by law.
• The licence runs from issue until 31 December of the following year and is renewed annually.
• One-stop licensing brings several bureaus into a single parallel procedure.

2. Legal basis

The framework combines the parent law, the implementing rules, the fee schedule approved by the Chief Executive, and the promotional materials published by the ISAF. The table below lists the instruments and the provisions cited in this article.

3. Expert insights

Insight one: the prohibition of retail of Class III devices is a hard constraint on the business model. The authorities make clear that Class III medical devices may by law only be supplied to healthcare establishments such as hospitals and clinics, and to research institutions. This is not a channel preference but a statutory restriction — companies whose portfolios involve coronary stents, implantable pacemakers, artificial joints, AEDs and similar products must design their business plans around direct sales to institutions.

Insight two: one-stop licensing is an administrative efficiency highlight, but many entities participate in parallel. The implementing rules provide: opinion of the Land and Public Works Bureau 30 working days; Fire Services Bureau, Labour Affairs Bureau and Cultural Affairs Bureau 15 working days each; ISAF 15 working days; and the ISAF decides within 5 working days after all opinions are received. A technical meeting may also be convened within 5 working days after receipt of the last opinion. The critical path is determined by the slowest participating entity.

Insight three: the correction window is extremely short. The implementing rules provide that participating entities notify omissions within 5 working days from receipt of the application; the ISAF notifies the applicant within 2 working days from becoming aware of the omissions and sets the period for correction; if the correction is not made in time, the application is not accepted. This is a compact process counted in working days.

Insight four: the works licence and inspection carry time pressure. After the plans are approved, the applicant must submit the inspection application within 6 months from receipt of the notification (one extension of the same period may be requested); otherwise the approval lapses; the ISAF conducts the inspection within 15 working days from receipt of the application.

Insight five: the renewal rhythm differs from that of the manufacturing licence. The business licence is renewed every December (by declaring continued compliance with the conditions under which it was issued); the manufacturing licence is renewed 90 to 180 days before expiry. The renewal points of the two licences differ and must be set up as separate reminders.

4. Practical recommendations

• Determine first whether a business licence is needed at all: import, export and wholesale of Class I and Class IIa devices do not require one, saving the MOP 2,000 fee and the entire licensing procedure.
• Design channels for Class III products as direct sales to institutions: retail channels are legally not viable.
• Schedule one-stop licensing around the slowest entity: treat the 30 working days of the Land and Public Works Bureau as the critical path.
• Treat the 6-month inspection application period as a hard milestone: missing it causes the approval to lapse.
• Handle renewal every December: manage it separately from the product registration renewal (90 to 180 day window).

5. Verification checklist

• □ Confirmed whether a business licence is required by classification (Class IIb and Class III import, export and wholesale, and Class IIb retail, require one)
• □ Channels for Class III products designed around the prohibition of retail
• □ Deadlines of the participating entities in the one-stop procedure built into the schedule
• □ Response mechanism for corrections established (notification within 2 working days, correction within the set period)
• □ 6-month inspection application period set as a project milestone
• □ Annual renewal reminder for December set up

Regulatory information verified as of 29 October 2026. The laws, guidelines and effective dates described in this article are limited to the content published by the official sources listed under Legal basis as of that date; where official documents are updated, the most recently published version prevails.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Macao, China. Our team coordinates local licence holder arrangements, import and supply requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com