Registration Dossier: The Fifteen Attachment Items under Article 10

1. Key takeaways

Article 10 of the Implementation Rules of the Medical Device Regulatory Regime divides the registration dossier into two layers. The first layer is the prescribed application form, which must state the name or designation and domicile of the applicant, the name of the medical device and the place of manufacture, an overview of the device covering its model or specification, class, performance, main structural composition or ingredients, mechanism of action, intended use and scope of application, as well as any accessories or products to be used together with the device, if applicable. The second layer consists of fifteen attachment items set out in paragraph 2, items (1) to (15). Within this list there is one significant relief clause: an applicant who is the holder of a manufacturing licence or of an operating licence is not required to submit items (1) to (3).

• The dossier structure is statutory: the application form content is fixed by Article 10(1) and the attachments by Article 10(2).
• Items (1) to (3) are administrative documents — commercial registration, criminal record and debt-free certificates — and can be waived through licence-holder status.
• Item (13), the overseas marketing evidence, must be obtained again at renewal under Article 18(2)(2).
• Item (15) takes two forms: proof of patent protection, or a declaration where the device is not protected by a patent.
• Article 10(5) is an open clause allowing ISAF to request further information on quality, effectiveness and safety.

2. Legal basis

The obligations summarised above rest on the following legal instruments. The Implementation Rules govern the composition of the dossier, while the founding law defines who may apply, what qualities the device must satisfy, and how clinical evaluation is handled. The published service information of the Pharmaceutical Administration Bureau lists the documents to be submitted for a first application, and the competent third-party review bodies are designated by a separate administrative ruling.

3. Expert insights

The fifteen attachments, item by item. The table below unpacks each attachment and the practical point attached to it.

First observation: items (1) to (3) can be displaced by licence-holder status. Article 10(3) is a rare load-reducing design in this regime: by first obtaining a manufacturing licence or an operating licence, the applicant saves three administrative documents at the registration stage. This directly reorders project scheduling — the licence should come before the registration, because the saving applies only to those who already hold one of the two licences. Planning the licence application as the first milestone therefore shortens the critical path of the whole market-entry programme and reduces the number of documents that may trigger formal review queries.

Second observation: item (13) must be submitted again at renewal. Article 18(2)(2) lists item (13) among the documents required for renewal. Overseas marketing status is therefore a continuing obligation, not a one-off hurdle cleared at first registration. If the foreign approval lapses during the registration cycle, the renewal dossier becomes incomplete, so the validity of the foreign certificate must be tracked against the Macao registration cycle.

Third observation: item (15) has two forms. Devices protected by a patent require documentary proof; devices not protected by a patent require a declaration. Submitting only the former without the latter, or vice versa, constitutes a gap in the dossier. The correct document is determined solely by the patent status of the device, and the choice should be documented in the compilation notes.

Fourth observation: Article 10(5) is an open clause. ISAF may, according to the actual needs of the review, require the applicant to submit, within a specified period, other information concerning quality, effectiveness and safety — and where this happens, the assessment period is suspended under Article 17(3). Applicants should anticipate this possibility in their timelines rather than treat the statutory review period as guaranteed.

4. Practical recommendations

• Use the fifteen-item list as a submission gate: do not launch a submission with any item missing, so as to avoid burning the 20 working days of the formal review stage on remediable defects.
• Obtain licence-holder status first: it directly waives items (1) to (3) and narrows the surface area for file requests.
• Treat item (15) as either-or but always required: prepare the proof or the declaration according to the patent status of the device.
• Start the overseas marketing evidence early: item (13) has a long lead time, and it must be submitted again at renewal.

5. Verification checklist

• □ The prescribed form has been completed with the four contents required by Article 10(1)
• □ All fifteen attachments have been checked one by one with no gaps
• □ It has been confirmed whether items (1) to (3) can be waived under licence-holder status
• □ Item (15) has been submitted as proof or as a declaration according to patent status
• □ Item (13) overseas marketing evidence has been obtained and covers the declared models
• □ Possible supplementary information requests under Article 10(5) have been anticipated

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