NMPA Seeks Public Comments: Clinical Evaluation Guidance for Cardiac RF Ablation Devices and Flow-Diverting Stents

On July 2, 2026, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) issued a notice soliciting public comments on two draft guidance documents: "Clinical Evaluation Registration Review Guidance for Cardiac Radiofrequency Ablation Devices (Draft for Comments)" and "Clinical Evaluation Registration Review Guidance for Flow-Diverting Stents (Draft for Comments)."

Key Highlights of the Draft Guidance

1. Cardiac Radiofrequency Ablation Devices

This guidance applies to cardiac RF ablation devices and catheters (classification codes 01-03-02 and 01-03-04, Class III), used in electrophysiology procedures to treat tachyarrhythmias via RF energy. The scope covers drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation and persistent atrial fibrillation (duration <1 year).

Key points:

l These are high-risk Class III devices; clinical trials are generally required

l Prospective, single-arm target value design recommended; minimum sample size of 120 subjects

l Primary effectiveness endpoint: 12-month treatment success rate (immediate success + 12-month freedom from treatment failure)

l Primary safety endpoint: composite rate of serious adverse events

l For products with a predicate version already approved in China, the same-product clinical evaluation pathway may be considered

2. Flow-Diverting Stents

This guidance applies to flow-diverting stents for hemodynamic remodeling (classification code 13-06-11, Class III), indicated for unruptured saccular or fusiform aneurysms in the internal carotid artery (petrous to terminal segment) in adults, with neck ≥4mm or dome-to-neck ratio <2, and parent vessel diameter 2.0mm-6.0mm.

Key points:

l These are high-risk Class III devices; clinical trials are generally required

l Prospective, single-arm target value design recommended; minimum total sample size of 120 subjects

l Primary effectiveness endpoint: 12-month complete aneurysm occlusion (Raymond Class I) with parent artery stenosis ≤50%

l Primary safety endpoint: death/major stroke within 30 days, or neurological death/major ipsilateral stroke within 12 months

Safety endpoint target value: in principle, <20%.

Comment Deadline: July 30, 2026

How to Submit: Complete the feedback form and email it to the designated contacts, with the subject line indicating the relevant guidance name and your organization.

Contacts:

Cardiac RF Ablation Devices: Wang Yawen (010-86452515, wangyw@cmde.org.cn), Dong Zheng (010-86452864, dongzheng@cmde.org.cn)

Flow-Diverting Stents: Wang Yawen (010-86452515, wangyw@cmde.org.cn), Yang Yuan (010-86452959, yangyuan@cmde.org.cn)