Labelling and Instructions for Use Requirements in Macao

1. Key takeaways

The requirements for medical device labelling and instructions for use in Macao, China are: at least one of the Chinese, Portuguese or English languages must be used. The label should in principle state the product name, model or specification, expiry date or date of manufacture, batch number or serial number, the name of the manufacturer or registration holder, the place of origin, the performance or scope of application, and the applicable precautions and warning information. Information that cannot all be shown on the label may be stated in the instructions for use; and a Class IIb medical device may be supplied without instructions for use if it can still be used safely in accordance with its intended purpose in the absence of such instructions.

• The three-language rule is a take-one rule: any single one of Chinese, Portuguese or English satisfies it.
• Eight mandatory label contents must be present, in the approved language.
• Label specimens are examined at registration through item (11) of Article 10(2).
• At renewal, the registration holder must declare conformity with the approved specimens under Article 18(2)(1).
• The Class IIb exemption from instructions for use is conditional and requires written justification (practical estimate).

2. Legal basis

The core labelling obligations come from the founding law, whose dedicated article governs the name, labelling and instructions for use. The technical detail — language, typography and content requirements — is set by the ISAF ruling, while the Implementation Rules determine when label specimens enter the dossier and what must be declared at renewal. Official industry information published by ISAF states the language rule and the mandatory label contents.

3. Expert insights

First observation: the take-one-of-three language rule is a fairly lenient language requirement. Only one of Chinese, Portuguese or English is needed, which is more flexible than markets demanding the local language plus the original language. For manufacturers from the Chinese mainland, a Chinese label satisfies the requirement — but it is still advisable to check the specific requirements of Ruling No. 6/ISAF/2026 on type size, legibility and the presentation of warning information, since language is not the only parameter of a compliant label and printing quality is part of the review.

Second observation: label specimens are examined at the registration stage. Article 10(2)(11) lists the specimens of the medical device labels and, where applicable, the instructions for use among the mandatory registration documents, which shows that labelling is not a matter attended to only after market entry; problems surface during the assessment. A label redesign forced by reviewer comments at this stage costs more than designing to the ruling from the start, and it may delay the approval decision itself. Where a device family shares a label layout, the family-wide implications of any single comment should be assessed before the reply is filed.

Third observation: the renewal requires a declaration that the labels match the approved specimens. Article 18(2)(1) requires the registration holder to submit a declaration confirming that the specimens of the medical device labels and, where applicable, the instructions for use conform to those approved by ISAF. This means label changes will be discovered at the renewal review — changes must first go through the change procedure and cannot wait for renewal. Companies should therefore treat any artwork revision, however small, as a regulated change with its own record.

Fourth observation: the Class IIb exemption from instructions for use is a targeted exception. The condition is that the device can still be used safely in accordance with its intended purpose without instructions for use. The exception does not extend to Class III devices, nor to Class I or IIa filing applications, since filing likewise requires item (11). Where the exception is invoked, a written justification should be prepared (practical estimate), explaining why safe use without printed instructions is realistic for the intended user group and use environment.

4. Practical recommendations

• Lay out the label according to Ruling No. 6/ISAF/2026 at the design stage: take type size, the placement of warnings and durability into account together.
• Keep a labelling register: archive the approved specimens, and route any change through the change procedure before printing.
• Proofread Chinese labels against local terminology: avoid ambiguities caused by directly reusing mainland terminology (practical estimate).
• Prepare the written argument in advance where the Class IIb exemption from instructions for use is intended.

5. Verification checklist

• □ Labels and instructions for use use at least one of Chinese, Portuguese or English
• □ All eight mandatory contents are shown (name; model or specification; expiry date or date of manufacture; batch or serial number; manufacturer or registration holder; place of origin; performance or scope of application; precautions and warnings)
• □ The label specimens were submitted with the dossier under Article 10(2)(11)
• □ The approved specimens are archived in the labelling register
• □ A written justification exists where the Class IIb exemption from instructions for use is invoked
• □ The label conformity declaration at renewal has been planned

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