Pre-Procedure Consultation for Registration, Notification and Licensing

1. Key takeaways

The Implementing Rules set a pre-procedure consultation stage for 3 categories of procedures: medical device registration (Article 12), medical device notification (Article 22), and licences for medical device business activities (the relevant provisions). The pre-procedure consultation for registration contains one special arrangement: at a critical stage of a clinical trial for an innovative medical device, ISAF may, at the request of an interested party and after analysing the interim research information and the content of the consultation, express an opinion or provide suggestions on the next research protocol, and for this purpose may request the opinion of the special committee. This is an official, low-cost channel for resolving uncertainty.

• Pre-procedure consultation covers 4 categories of questions: requirements, documents, procedure and fees.
• For innovative devices, the consultation is substantive and can be used to obtain regulator feedback on the research protocol before large-scale clinical investment.
• For notification, the consultation pairs with the formal review in a design aimed at simplification.
• Recognition of self-defined quality standards should also be pursued through the consultation.
• The consultation stage exists for all 3 procedure categories, so no filing or licence project in Macao, China should start without it.

2. Legal basis

The pre-procedure consultation stages for registration, notification and licensing are governed by the following instruments, verified as of 29 October 2026.

3. Expert insights

Insight 1: the pre-procedure consultation covers 4 categories of questions — requirements, documents, procedure and fees. The wording of Article 12(1) is that an interested party may request consultation services from ISAF on the requirements, documents required, procedure and fees for registration. These 4 categories cover virtually all of the uncertainty before submission, and companies should not treat it as an optional courtesy step to be skipped when the schedule is tight.The consequences of skipping it are paid for later in deficiency corrections, resubmissions and dispute handling.

Insight 2: the consultation for innovative devices is substantive, not ceremonial. Article 12(2) allows ISAF, at a critical stage of a clinical trial for an innovative device, to express an opinion or provide suggestions on the next research protocol, and to request the opinion of the special committee. This means that companies can obtain regulator feedback on the research protocol before committing large-scale clinical resources — one of the most valuable institutional designs for innovative products, because it reduces the risk of investing in a study design that the regulator would later question.

Insight 3: the pre-procedure consultation for notification pairs with the formal review, with the aim of simplification. In introducing the Implementing Rules, the authorities explained that the notification procedure introduces a pre-procedure consultation stage and simplifies the market procedures for low-risk medical devices through a formal review of the application. Consultation and simplification form a single combined design, not two separate measures.

Insight 4: recognition of self-defined quality standards should also go through the consultation. Article 12(2)(2) allows the submission of other standards submitted by the applicant and recognised by ISAF — the recognition takes place before submission, and the pre-procedure consultation is the natural occasion for obtaining it. Where no mandatory national standard applies to the product, the applicant may propose its own standard and secure ISAF recognition at this stage, so that the recognised standard can be cited directly in the dossier afterwards.

4. Practical recommendations

• Make the pre-procedure consultation a mandatory project step: complete it before dossier preparation begins and settle all uncertain points in one round.
• Prepare a written question list before consulting: organise questions under the 4 categories of requirements, documents, procedure and fees, to avoid undocumented oral communication.
• Consult by stage for innovative devices: submit interim research information before the clinical trial reaches a critical node and request the opinion of ISAF on the next protocol.
• Obtain recognition of self-defined standards first: where no mandatory national standard applies, use the consultation to confirm the acceptability of the company standard.
• Archive the consultation outcomes: use them as the basis for subsequent dossier preparation and dispute handling, so that every answer given by the regulator before submission can be traced back to a written record.

5. Verification checklist

• □ It has been confirmed which category of pre-procedure consultation applies (registration, notification or licence)
• □ A written consultation list has been prepared under the 4 categories of questions
• □ For innovative devices, protocol consultation at the critical stage has been planned
• □ Recognition of self-defined quality standards has been obtained through the consultation
• □ The consultation outcomes have been archived in writing
• □ The consultation records have been cross-referenced with the subsequent dossier

Regulatory information verified as of 29 October 2026. The regulations, 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 subsequently updated, the latest 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 manages Health Bureau (SSM) pre-market registration and notification applications, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com