Device Naming Rules: Five Prohibitions for Medical Device Names

1. Key takeaways

The Implementation Rules devote a dedicated article to the naming of medical devices, listing five prohibitions: the name must not (1) mislead as to the quality, effectiveness or safety of the medical device; (2) contravene public morals or good customs; (3) use wording that compares the device with other medical devices; (4) contravene the provisions on the protection of industrial property; (5) use conceptual names that are unproven scientifically or by clinical evaluation, or that are illusory or hypothetical. The rules for assigning generic names of medical devices are laid down in a technical instruction issued by ISAF (Ruling No. 6/ISAF/2026). The name is simultaneously one of the statutory requirements under Article 12(1)(4) of the founding law.

• All five prohibitions must be tested against the proposed name before submission.
• Comparative wording is the pitfall most frequently tripped by manufacturers from the Chinese mainland.
• Conceptual names without scientific or clinical support also jeopardise the effectiveness review under Article 12.
• The name is a mandatory field of the prescribed application form under Article 10(1)(2).
• Changing an approved name later runs through the registration change procedure of Article 23, with up to 100 working days for items requiring prior approval.

2. Legal basis

The naming prohibitions come from the Implementation Rules, the generic naming rules and the technical requirements for labelling and instructions for use come from the ISAF ruling, and the statutory linkage runs through the founding law, which makes the name part of the device requirements and dedicates an article to name, labelling and instructions for use. The prescribed form provision confirms where the name must appear.

3. Expert insights

First observation: the third prohibition, banning wording that compares the device with other medical devices, is the provision most easily breached by manufacturers from the Chinese mainland. In the mainland market, expressions such as a new generation, an upgraded version, or better than a certain product are to some extent customary; in Macao, China, such wording directly violates the naming rules. Note that the prohibition targets the name, but the risk of the same wording and its source in promotional claims should be managed together, because marketing language travels easily from packaging to labelling and back into the approved name through reprinting cycles.

Second observation: the fifth prohibition targets illusory or hypothetical conceptual names. This provision addresses concept words lacking scientific proof or clinical evaluation support, of the kind associated with quantum, nano-energy or bio-resonance claims. Such a name not only breaches the naming rules but may also compromise the review of the effectiveness requirement under Article 12, since a device whose very name suggests unproven mechanisms invites scrutiny of whether the effectiveness evidence matches the claim embedded in the name.

Third observation: the naming rules intersect with industrial property. The fourth prohibition brings contravention of the provisions protecting industrial property within the scope of the naming article, which means the name must not infringe the trademark or patent rights of others. This echoes Article 15 of the founding law on patent-protected medical devices — Article 10(2)(15) requires either documentary proof of patent protection or a declaration where the device is not patent-protected. Name clearance searches are therefore part of dossier compilation, not a separate marketing exercise.

Fourth observation: the name is a mandatory field of the prescribed form. Article 10(1)(2) requires the form to state the name of the medical device and the place of manufacture. Once a name is approved, any subsequent change must go through the registration change procedure of Article 23, and for changes requiring prior approval the process can take up to 100 working days — nearly the length of a full registration assessment, which is why naming decisions made at the project stage pay for themselves later.

4. Practical recommendations

• Fix the name at the project stage: design the generic name according to the naming rules of Ruling No. 6/ISAF/2026 to avoid a later rename.
• Maintain an internal list of banned words: enter comparative wording, absolute claims and unproven concept words into the internal prohibition table, applied to names and to promotion alike.
• Search trademarks and patents in parallel with naming: avoid contravening the industrial property provisions of the fourth prohibition.
• Plan name changes as major changes: a rename may trigger the prior approval procedure, whose time cost approaches a complete registration.

5. Verification checklist

• □ The name has been tested item by item against the five prohibitions
• □ The generic name complies with the naming rules of Ruling No. 6/ISAF/2026
• □ The name uses no comparative wording or unproven conceptual terms
• □ Trademark and patent searches have been completed with no industrial property conflicts
• □ The name is identical in the prescribed form, on the labels and in the instructions for use
• □ The procedural cost of a name change (Article 23) has been assessed

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