Official Fee Schedule for Licences and Registration in Macao

1. Key takeaways

The official fees of the medical device regime in Macao, China are set out in the Fee Schedule for Medical Device Business Activities and Medical Device Registration approved by Dispatch of the Chief Executive No. 144/2026 (published on 15 June 2026 in Official Gazette No. 24/2026, effective on 1 July 2026). The schedule is organised in two blocks: licences for medical device business activities (manufacturing licence MOP 9,000, renewal MOP 3,000; business licence MOP 2,000, renewal MOP 300; contract manufacturing permit MOP 500, renewal MOP 200) and medical device registration (registration MOP 500, renewal MOP 200, reissue of the registration certificate MOP 200).

• All official fees are contained in one dispatch, effective from 1 July 2026.
• Licence fees range from MOP 500 to MOP 9,000 at first issue.
• Registration costs MOP 500, with renewal and certificate reissue at MOP 200 each.
• Official fees are a small fraction of the total cost of market access.
• Whether filing carries a separate fee item is pending verification against the official payment notices.

2. Legal basis

The fee schedule is anchored in the Chief Executive dispatch, and its application connects to the licence, registration and renewal provisions of the parent law, the implementing rules and the renewal dispatch. The table below lists the instruments relied on in this article.

3. Expert insights

Insight one: official fees are a tiny share of total cost; the real cost lies in compliance preparation. The registration fee for a Class III device is only MOP 500, and the manufacturing licence MOP 9,000 — extremely low levels compared with the Chinese mainland and the European Union. The purpose of this schedule is threshold confirmation, not budgeting — the real expenditure of companies lies in obtaining proof of overseas marketing, test reports, clinical evaluation, GMP system documentation and localised labelling. In its quotations, GRZAN often meets clients who assume that low official fees mean a low total cost; this is the first point that needs to be clarified.

Insight two: renewal fees are generally 20 to 40 per cent of the first issue fee, with the business licence the only outlier. The manufacturing licence runs from 9,000 to 3,000 (about 33 per cent), registration from 500 to 200 (40 per cent), and the contract manufacturing permit from 500 to 200 (40 per cent), while the business licence runs from 2,000 to 300 (15 per cent). This structure shows that the legislator deliberately kept the cost of market entry for the distribution stage low, so that distribution and retail networks can expand quickly, with regulatory weight placed on manufacturing and on the products themselves.

Insight three: the reissue of a certificate is listed separately at MOP 200, the same as renewal. Where a registration certificate is damaged or lost and must be reissued, the fee is MOP 200. This item is often overlooked, yet the probability of loss is not low for cross-border entities in certificate circulation, bank account opening and customs filing scenarios; companies are advised to write reissue handling into their internal certificate management system.

Insight four: the fee schedule is separate from ex officio procedures. Inspections, investigations and sampling tests carried out by the ISAF on its own initiative are a different category of acts from licences, registrations and permits issued upon application. The fee schedule targets acts performed upon application; companies should not budget on the assumption that inspections must be paid for, and conversely should not expect that paying fees will accelerate the review.

Insight five: whether filing carries a separate fee item must be confirmed against the official text of the schedule. Law No. 12/2025 places Class I and Class IIa devices on the filing channel and Class IIb and Class III devices on the registration channel. Practical estimate: at the time of verification by GRZAN, the schedule lists items under the two headings of licences for medical device business activities and medical device registration; whether filing is listed as a separate fee item is subject to the payment notices published by the ISAF (pending verification); when budgeting, companies are advised to reserve zero or a low amount, and to reserve administrative time for handling the payment notice.

4. Practical recommendations

• Budget official fees separately from compliance service costs: official fees are in the hundreds to a few thousand Macao patacas, while compliance preparation is the main expenditure.
• Run a five-year full-cycle calculation on the basis of one application plus one renewal: registration, with a 5-year validity, corresponds to 500 plus 200; the manufacturing licence, with a 3-year validity, corresponds to 9,000 plus 3,000.
• Write the certificate reissue procedure into the certificate management system: define the responsible person, the storage method and the reissue application path (MOP 200).
• Follow the payment notice of the ISAF: amounts and items are governed by the official notice, not by historical experience or the experience of others.

5. Verification checklist

• □ Official text of the fee schedule in Dispatch of the Chief Executive No. 144/2026 obtained
• □ Manufacturing licence 9,000 and renewal 3,000 MOP included in the budget
• □ Business licence 2,000 and renewal 300 MOP included in the budget
• □ Registration 500, renewal 200 and certificate reissue 200 MOP included in the budget
• □ Contract manufacturing permit 500 and renewal 200 MOP included in the budget
• □ Fee treatment of filing confirmed with the ISAF
• □ Number of renewals within the 5-year and 3-year cycles calculated
• □ Payment method and rules for keeping payment receipts defined

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