Foreign Trade Operator as Filing Applicant in Macao

1. Key takeaways

Article 11(2)(1) of Law No. 12/2025 provides that, for Class I or Class IIa medical devices, the filing application must be submitted by a foreign trade operator who meets the requirements of Article 11(1)(3) (not being in a period of supplementary penalty, supplementary sanction or security measure prohibiting an application for registration or filing). Article 21(3) of the implementing rules further provides that applicants that are holders of a manufacturing licence or foreign trade operators are not required to submit the materials listed in Article 21(2)(1) and (2) (applicant information, criminal record certificate and no-debt certificate). The foreign trade operator is both the key to the low-risk import channel and the basis for the simplified documentation set.

• Class I and Class IIa devices enter Macao, China through the filing channel, with a foreign trade operator as applicant.
• The foreign trade operator concept comes from Law No. 7/2003 and has no separate licence of its own.
• Foreign trade operators and manufacturing licence holders are exempt from two categories of administrative documents.
• Technical documents remain mandatory despite the exemption.
• Proof of overseas marketing remains a filing requirement that cannot be waived.

In practical terms, the foreign trade operator route determines how easily a low-risk portfolio enters Macao, China. Companies importing Class I and Class IIa devices should confirm at the outset who acts as the foreign trade operator, because the filing cannot be submitted without a qualifying applicant, and because the eligibility of that applicant directly determines whether the document exemptions of Article 21(3) of the implementing rules can be used.

2. Legal basis

The foreign trade operator pathway rests on the parent law and the implementing rules, and connects to the foreign trade regime established by Law No. 7/2003. The table below summarises the instruments and provisions cited in this article.

3. Expert insights

Insight one: the foreign trade operator is an existing legal concept, not a newly created status. The regime directly carries over the concept of foreign trade operator established under Law No. 7/2003, the Foreign Trade Law, without creating a separate licence for it. This contrasts with Class IIb and Class III devices, for which the applicant must be a business licence holder — the threshold for the subject qualifying for the low-risk channel is markedly lower. For companies building an import structure, this means the commercial decision of who holds the foreign trade operator status can be made independently of the medical device licensing decisions, since no additional device-specific licence is required for Class I and Class IIa filing.

Insight two: the scope of the document exemption covers items (1) and (2). Article 21(3) exempts two categories of administrative documents, namely applicant information and the criminal record certificate and no-debt certificate. Technical documents (items (3) and (4)) must still be submitted. What is exempted is the administrative burden, not the technical requirements.

Insight three: foreign trade operators must still satisfy the good-character requirement. Article 11(2)(1) makes reference to Article 11(1)(3), namely not being in a period of supplementary penalty, supplementary sanction or security measure prohibiting an application for registration or filing. Although no proof needs to be submitted on this point by virtue of Article 21(3), the substantive requirement remains in force, and the ISAF may verify it by other means.

Insight four: proof of overseas marketing must still be filed. Article 21(2)(4) makes reference to Article 10(2)(13) — the status of foreign trade operator does not waive the requirement of prior marketing in the country of origin. This is the single most demanding document in the low-risk channel. Its lead time is driven by foreign authorities rather than by the ISAF, so it should be ordered from the manufacturer as early as the import project is scoped.

Read together, these four points define the profile of the low-risk import route in Macao, China: a recognised applicant drawn from the existing foreign trade framework, a reduced set of administrative documents, a substantive good-character requirement that stays in force even where no proof is filed, and an unchanged obligation to evidence prior marketing in the country of origin. Companies that plan around this profile can prepare the filing dossier in parallel with their commercial arrangements instead of sequencing them one after the other.

4. Practical recommendations

• Identify the foreign trade operator before importing low-risk devices: without a qualifying applicant, no filing can be submitted.
• Submit in the capacity of a foreign trade operator: this removes the documents under items (1) and (2) and shortens preparation time.
• Obtain proof of overseas marketing early: it is the document in the filing that cannot be waived and has the longest lead time.
• Verify the status of the foreign trade operator: confirm that its qualification as a foreign trade operator is valid and that it is not in a prohibited period.

5. Verification checklist

• □ Confirmed that the device is Class I or Class IIa (filing applies)
• □ Qualified foreign trade operator identified
• □ Confirmed that the foreign trade operator is not in a period prohibiting application for registration or filing
• □ Exemption of documents under items (1) and (2) applied in accordance with Article 21(3)
• □ Proof of overseas marketing under item (13) obtained
• □ Technical documents under items (3) and (4) completed

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