Innovative Medical Devices and Third-Party Technical Review Reports

1. Key takeaways

The Implementing Rules design a defined channel for innovative medical devices: for devices whose main working principle or mechanism of action is a world first, whose technology is at an internationally leading level, and which have significant clinical application value, the applicant may, upon submission, provide a report on quality, effectiveness and safety issued by a credible third-party technical review body (Article 10(2), item (14)). The legal effect of submitting this report is that, before the Director of ISAF makes the decision, the opinion of the special committee need no longer be obtained (the proviso in Article 15(2)). The list of bodies is established by Dispatch No. 15/ISAF/2026.

• The innovative device definition rests on 3 cumulative conditions, all of which must be satisfied at once.
• The third-party assessment report substitutes for the special committee opinion in the decision stage.
• Only bodies on the list in Dispatch No. 15/ISAF/2026 produce that legal effect.
• A higher degree of innovation increases the likelihood of a development-site inspection under Article 14(2).
• The mechanism shifts the burden of proof to the company: the credible third-party assessment must be obtained by the applicant itself, at its own cost and initiative.

2. Legal basis

The innovative medical device channel and the third-party technical review mechanism are governed by the following instruments, verified as of 29 October 2026.

3. Expert insights

Insight 1: the 3 conditions must be satisfied simultaneously for a device to qualify as an innovative medical device. The provision reads: the main working principle or mechanism of action is a world first, the technology is at an internationally leading level, and the device has significant clinical application value — the three are cumulative. A device that is merely technologically advanced but lacks significant clinical value does not qualify; likewise, a device with a first-of-its-kind mechanism whose technology has not reached the internationally leading level does not qualify.

Insight 2: the legal effect of the assessment report is written in very specific terms. Article 15(2) provides that the opinion of the committee shall be obtained before the registration decision for an innovative device, except where the applicant submits the third-party assessment report. This is a mechanism that replaces expert evaluation with third-party technical review: it removes a step and shifts the burden of proof — the company must itself obtain the assessment report from a credible body.

Insight 3: the pre-procedure consultation under Article 12(2) has special value for innovative devices. Article 12(2) allows ISAF, at a critical stage of a clinical trial for an innovative device, to express an opinion on the next research protocol, and to request the opinion of the committee. The feedback obtained at this stage complements the subsequent third-party assessment report, because the same research questions examined by the regulator during the consultation can be handed to the commissioned body, making the assessment report more consistent with the expectations formed during the trial.

Insight 4: the list-based system means the pool of bodies is limited. Article 15(3) makes clear that the third-party bodies are established by the technical instruction of ISAF (Dispatch No. 15/ISAF/2026). A report issued by a body not on the list does not produce the effect of exemption from the committee opinion; it can only serve as supporting material.

Insight 5: innovative devices are more likely to trigger a development-site inspection. Article 14(2) provides that ISAF decides whether to conduct a development-site inspection based on, among other factors, the degree of innovation of the medical device. The higher the degree of innovation, the greater the likelihood of an inspection.

4. Practical recommendations

• Run a self-assessment against the 3 innovation conditions first: set out each cumulative condition in a written argument, placed at the front of the application documents.
• Check the body list before commissioning: before commissioning the assessment, confirm that the body is on the list in Dispatch No. 15/ISAF/2026.
• Make full use of the pre-procedure consultation: obtain the opinion of ISAF on the research protocol at the critical stage of the clinical trial before commissioning the third-party assessment.
• Prepare the development site in advance: a higher degree of innovation means a higher probability of inspection, and development records and data-reliability documents should be organised ahead of time.

5. Verification checklist

• □ A written argument covering the 3 conditions of first-of-its-kind mechanism, internationally leading technology and significant clinical value has been completed
• □ The third-party body to be commissioned is on the list in Dispatch No. 15/ISAF/2026
• □ The assessment report covers quality, effectiveness and safety
• □ The opinion of ISAF on the research protocol has been obtained through the pre-procedure consultation
• □ Preparation for the development-site inspection has been completed
• □ The consequences of not submitting the assessment report, namely the requirement of a committee opinion, have been confirmed

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