Overseas Marketing Evidence and the Hengqin Exemption

1. Key takeaways

Article 10(2)(13) of the Implementation Rules requires that, for a medical device manufactured outside the Macao Special Administrative Region of China, the applicant must submit evidence of the marketing of the device issued by the competent authority or empowered body of the place of origin or of the country or region where marketing has been approved; this does not apply to devices manufactured in the regions designated by a Chief Executive order published in the Bulletin — and the region designated by Chief Executive Order No. 142/2026 is the Guangdong-Macao Intensive Cooperation Zone in Hengqin. The document must be submitted again at renewal (Article 18(2)(2)).

• The word ‘or’ in the provision opens two evidence routes: the place of origin, or any other market that has approved the device.
• Only a competent authority or an empowered body may issue the evidence; associations, distributors and self-declarations do not qualify.
• Devices manufactured in Hengqin are exempt from the requirement — the strategically most valuable carve-out of the regime.
• The obligation is continuous: renewal cannot proceed without fresh evidence under Article 18(2)(2).
• The validity of the foreign approval must be tracked against the 5-year Macao registration cycle.

2. Legal basis

The requirement sits in the registration attachment list and is repeated for filing applications and for renewals. The founding law supplies the underlying principle that devices manufactured elsewhere must already be registered or hold a sales authorisation abroad, and the Chief Executive order designates the single exempted territory.

3. Expert insights

First observation: the word ‘or’ in the provision provides two routes for obtaining the evidence. The document may be issued by the competent authority of the place of origin or by the competent authority of the country or region where marketing has been approved. This means a company need not insist on the manufacturing jurisdiction — where evidence is difficult to obtain in the country of origin, an approval document from another market that has already approved the device (for example an EU member state or the United States) can be used instead. Choosing the route with the most accessible issuing authority is a legitimate planning decision.

Second observation: the wording ‘competent authority or empowered body’ limits who may issue the document. Certificates from industry associations, statements from distributors, self-declarations and certificates from commercial third-party organisations do not meet the formal requirement. The issuer must be an official competent authority or a body empowered by it. Applicants should keep on file the official source through which the issuing body’s mandate can be verified, because that is the first thing a reviewer checks when the document comes from an unfamiliar signature block.

Third observation: the Hengqin exemption is the clause of greatest strategic value in this regime. For devices manufactured in the Hengqin cooperation zone, registration or filing does not require the marketing evidence from the place of origin. For innovative products that have not yet obtained any foreign approval, this is the only realistic route to the Macao market — placing production capacity in Hengqin amounts to acquiring the key to market access in Macao. The exemption is defined by the Chief Executive order designating the territory, so its scope is territorial, not corporate: the manufacture itself must occur there.

Fourth observation: the requirement recurs at renewal and thus constitutes a continuing obligation. Article 18(2)(2) includes item (13) among the renewal documents. The lapse of a foreign approval (for example the expiry of a CE certificate) directly blocks the renewal of the Macao registration, which is a hidden risk point in long-term compliance management. Certificate expiry dates should sit in the same compliance calendar as the Macao registration itself, with renewal of the foreign approval triggered well before the Macao renewal window opens.

4. Practical recommendations

• First confirm whether the place of manufacture falls within the Hengqin cooperation zone: if so, the requirement is waived; if not, evidence must be obtained.
• Choose the jurisdiction where evidence is easiest to obtain: the place of origin or any approved market qualifies; select by difficulty and lead time.
• Verify the issuing body’s standing: confirm the document is issued by a competent authority or a body empowered by it, and keep the verification route on file.
• Enter the validity of the foreign approval into the compliance register: align it with the 5-year validity of the Macao registration so that renewal is not blocked.

5. Verification checklist

• □ It has been confirmed whether the place of manufacture belongs to the Hengqin cooperation zone (Chief Executive Order No. 142/2026)
• □ For non-Hengqin manufacture, marketing evidence from the place of origin or an approved market has been obtained
• □ The issuing body meets the competent-authority-or-empowered-body requirement
• □ The evidence covers the declared models and specifications
• □ The validity of the evidence is tracked in the register and aligned with the Macao registration validity
• □ It has been confirmed that the evidence must be submitted again at renewal (Article 18(2)(2))

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Macao, China. Our team prepares SSM-compliant dossiers, coordinates language and legalisation requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com