NMPA Delivers 13 Device Approval Certificates on 28 October 2026: Imported PFA Ablation Catheter and Domestic Mapping Catheter Clear in the Same Batch

NMPA Delivers 13 Device Certificates on 28 October 2026: Imported PFA Ablation Catheter and Domestic Mapping Catheter Clear in the Same Batch

Published 30 October 2026, 18:32 — Registration and Market Access

On 28 October 2026, the National Medical Products Administration (NMPA) government services portal posted the Medical Device Approval Certificate Delivery Information for 28 October 2026. All 13 products listed carry an approval date of 27 October 2026: nine domestic and four imported, with acceptance numbers prefixed CQZ and JQZ respectively.

What the Delivery Notice Does and Does Not Cover

The meaning of this step should be stated precisely. The delivery notice only informs the applicant that the approval certificate is ready for collection; the content of the certificate is a separate matter. The table contains only six fields: acceptance number, product name, applicant, agent, registration certificate number and approval date. Indications for use, structural composition and manufacturing address are not included in this table.

Domestic Side: Energy Surgery Clusters, One Mapping Catheter in Between

Of the nine domestic certificates, energy-based surgery and laser products account for the majority:

• Weihai Weigao Laser Medical Equipment Co., Ltd. — dual-wavelength laser surgical equipment (Domestic Registration Certificate No. 20263012215)
• Nanjing Yigao Medical Technology Co., Ltd. — Q-switched Nd:YAG laser therapy device (No. 20263092216)
• Shandong Weirui Surgical Medical Products Co., Ltd. — single-use powered endoscopic linear vessel cutting stapler and components (No. 20263012214)
• Changzhou Heraeus Minimally Invasive Medical Devices Co., Ltd. — single-use powered linear cutting stapler and reload cartridge assembly (No. 20263012221)
• Hunan Banqiu Medical Technology Co., Ltd. — single-use bipolar high-frequency and ultrasonic dual-output soft tissue surgical instrument (No. 20263012213)
• Beijing Sumai Medical Technology Co., Ltd. — single-use ultrasonic soft tissue surgical blade (No. 20263012220)

The remaining three certificates point in different directions: an electrosurgical endoscope from Guangzhou Yisheng Technology Co., Ltd. (No. 20263062218); a radiofrequency skin treatment device from Refumei Medical (Shenzhen) Co., Ltd. (No. 20263092219); and a single-use circular mapping catheter from Suzhou Lvzhi Medical Technology Co., Ltd. (No. 20263072217).

The circular mapping catheter merits a closer look. Mapping catheters capture intracardiac electrical signals and build three-dimensional models; they represent the imaging and localisation half of an electrophysiology procedure, a position historically held largely by imported products. A domestic company obtaining this certificate means that, on the same procedure table, both the seeing and the burning sides now have domestic participants.

Imported Side: One Radiotherapy Platform and Three Electrophysiology Certificates

• Elekta Solutions AB — medical electron linear accelerator (Imported Registration Certificate No. 20263050385), agent: Elekta (Shanghai) Medical Devices Co., Ltd.
• Medtronic — 3D cardiac electrophysiology mapping system (No. 20263070383) and single-use magnetically tracked mapping dual-energy ablation catheter (No. 20263010384), both with Medtronic (Shanghai) Management Co., Ltd. as agent
• Biosense Webster, Inc. (Johnson & Johnson group) — single-use magnetically tracked cardiac pulsed field ablation catheter (No. 20263010386)

Mapping and Ablation Approved Together: The Channel Has Been Proven

Viewed side by side, the four imported certificates cover three electrophysiology seats with a complete division of labour: one 3D mapping system, one magnetically tracked dual-energy ablation catheter and one magnetically tracked pulsed field ablation catheter. Adding the domestic circular mapping catheter, this single batch clears both the mapping and the ablation ends of the procedure.

The value lies in the completeness of the set. An electrophysiology procedure cannot be performed with a catheter alone: mapping identifies targets and builds the model, ablation delivers the therapy, and magnetic tracking aligns the two. Only when the capital system and the catheters enter together can a hospital realistically begin scheduling cases; catheters without the system will not build an installed base. This batch supplies both, so installation and training schedules have a starting point.

A second signal is the parallel development of technology routes. Dual-energy ablation combines radiofrequency with a second energy modality, while pulsed field ablation is non-thermal. Both routes obtained certificates in the same batch, indicating that the review pathways for both energy types are mature and no longer require case-by-case exploration. Suppliers of sheaths, connection cables, irrigation pumps and body-surface reference electrodes should read this signal carefully: the denser the approvals for capital systems and catheters, the earlier the consumable replacement cycle starts.

Same Day: CMDE Splits Service Life into Two Evaluation Routes

On 28 October 2026, CMDE published a common-questions answer (page reference 20261028090213117) that turns the service life of active devices into an operationally comparable exercise. Service life is the period during which the registration holder guarantees safe and effective use through risk management. Evaluation may take the form of direct verification of the complete system, or may be decomposed into subsystems or components evaluated separately; once the expected period is established, the study data are submitted with the registration application, and post-market risk analysis continues to re-evaluate it. The underlying document is the Guideline on Technical Review of Service Life for Active Medical Device Registration.

This is directly relevant to companies building capital equipment. The mapping systems, ablation generators and laser devices approved in the batch above all require a service-life chapter in their registration files, and reviewers focus on how the model parameters are justified: which activation energy value is used, how temperature stress is set, and how clinical use frequency is converted into cycle counts. Writing that evaluation follows the guideline is boilerplate; setting out the source of each of the three parameters together with a sensitivity analysis is what actually answers the question.

What the Delivery Notice Can and Cannot Prove

What it can prove: the registration certificate numbers for the 13 products have been assigned, the approval date falls on 27 October 2026, and the correspondence between each applicant and its domestic agent is clearly verifiable.

What it cannot prove: the table contains no indications for use, no structural composition and no indication of whether approval was conditional. Inferring a product's indications or the competitive landscape from the word approved goes beyond the source text. A further point is often overlooked: registration approval and the ability to sell are two different things. Business licensing, reimbursement coding, hospital access and centralised procurement each carry their own thresholds, and the delivery notice covers only the first gate.

AIMEILI Regulatory Interpretation

Three points stand out for regulatory strategy. First, the simultaneous clearance of a 3D mapping system, a magnetically tracked dual-energy ablation catheter and a magnetically tracked pulsed field ablation catheter in one batch confirms that NMPA and CMDE now handle electrophysiology as a system-level portfolio rather than as isolated catheters; applicants should plan system-plus-catheter filings as a coordinated package, since the clinical evidence, software documentation and EMC/transport considerations interlock. Second, the presence of a domestic circular mapping catheter alongside imported mapping platforms shows that the domestic clinical evidence base for mapping hardware is now acceptable, which lowers the evidentiary barrier for subsequent domestic entrants. Third, the CMDE service-life answer formalises two acceptable routes — whole-system verification or decomposition to subsystems and components — and reviewers will look for the parameter derivation and sensitivity analysis behind whichever route is chosen, so the service-life chapter should be drafted early, not appended at the end.

For combination components such as stapler reload cartridges and ultrasonic blades approved in the same batch as their capital instruments, the registration strategy differs from that of the parent device: whether the parent's clinical data can be leveraged, and whether standalone performance and biocompatibility testing is required, depends on how the pairing is written into the indications for use. That drafting decision should be made before the test plan is frozen.

Business Impact

• Electrophysiology suppliers and distributors: treat the approval of systems and catheters as a leading indicator of installation scheduling. Between certificate issuance and the first clinical case there is typically a training and room-refurbishment interval; the stocking window for consumables falls inside that period, and preparing materials one quarter ahead is a reasonable buffer.
• Energy surgery device makers: this domestic batch includes both capital units and combination items such as blades and cartridges. Combination-item registration strategy should be fixed early, because it drives whether the file is standalone or linked.
• Companies preparing overseas registration: while the domestic dossier is still current, run both service-life evaluation routes domestically first. The same ageing model and the same parameter justification can then be used to answer notified body questions point by point during international filing.
• Hospitals and procurement teams: the delivery notice is an early signal of forthcoming availability, not confirmation of reimbursement or access status; tendering and coding steps should be tracked separately.

Sources and Scope Notes

Source: NMPA Government Services Portal, Medical Device Approval Certificate Delivery Information for 28 October 2026, published 28 October 2026; all 13 products listed carry an approval date of 27 October 2026. https://www.nmpa.gov.cn/zwfw/sdxx/sdxxylqx/qxpjfb/20261028170255155.html

Source: Center for Medical Device Evaluation (CMDE), common-questions answer What Is the Service Life of an Active Medical Device?, page reference 20261028090213117, published 28 October 2026, citing the Guideline on Technical Review of Service Life for Active Medical Device Registration. https://www.cmde.org.cn/splt/ltgxwt/20261028090213117.html

Verification scope and access date: the NMPA page was accessed directly on 30 October 2026 and the acceptance numbers, product names, applicants, agents, registration certificate numbers and approval dates were checked row by row, confirming 13 rows in total, comprising 9 domestic and 4 imported. The CMDE page was accessed on the same day but could not be retrieved in full at that time, so that item relies on a verified page summary recorded on 30 October 2026 rather than a full verbatim re-read. All dates, certificate numbers and product names in this article are taken from the two official pages cited above.

Scope note: this article is an interpretation of publicly available regulatory information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. Indications for use, structure and conditional-approval status are governed by the registration certificate and instructions for use as issued; information may change with subsequent official updates.