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NMPA Roundup March 2024

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in March 2024. These updates are presented by China Med Device, LLC, your partner in Chinese market access.

Policies

Medical Device Companies Annual Self-Inspection Report Due March 31

All domestic and overseas manufacturers with approved medical devices shall conduct the annual self-inspection of the quality management system and submit the report by March 31, 2024, according to the “Guideline for Annual Self-Inspection Report on Medical Device Quality Management System”.

For the contents in the self-report and the specific requirements for overseas manufacturers, please click HERE

Guidelines & Standards

Clinical Trial Draft Guideline Issued for Peripheral Drug-Coated Balloon Catheter

NMPA published the “Draft Guideline on Clinical Trial of Peripheral Drug-Coated Balloon Catheters” on February 5, 2024 for feedback.

This guideline is applicable to peripheral drug-coated balloon catheters, which is Class III devices, used in percutaneous transluminal angioplasty (PTA). It is for the treatment of peripheral arterial obstructive diseases, including diseases affecting the femoropopliteal artery, infrapopliteal artery, and stenotic lesions in peripheral autogenous arteriovenous fistula for hemodialysis access.

please click HERE for the clinical trial design and overseas clinical data acceptance in the proposed guideline,

RFA & MWA Equipment Clinical Guideline Asks Feedback

NMPA issued the “Clinical Evaluation Guideline with Predicate Comparison of Radiofrequency Ablation (RFA) and Microwave Ablation (MWA) Equipment (Draft)” for feedback on February 18, 2024.

RFA and MWA equipment is intended to treat liver cancer or thyroid nodules. Cardiac ablation is excluded. Devices used for vein ablation can be referenced in the applicable sections.

RFA uses radio waves with a frequency greater than 100 kHz but not exceeding 5 MHz. MWA uses microwaves with a frequency greater than 300 MHz but not exceeding 30 GHz.

For the predicate comparison pathway, technical features and safety and efficacy evidence for discrepancies, animal testing requirements and IFU writing, please click HERE

Fast-Track Approvals

NMPA Review Report Released for Israeli Osteosynthesis Plate System

The NMPA granted innovation approvals to Israeli company CarboFix Orthopedics’ carbon fiber polyetheretherketone (PEEK) osteosynthesis plate system and issued a review report.

For the product overview and preparation of pre-clinical and clinical data guided by the review report, please click HERE

PMS & QMS

Covidien Recalls 188 Nonabsorbable Suture in China

Covidien issued voluntary recall notice for Coated Braided Nylon Nonabsorbable Suture on February 6, 2024. It is a Class I recall, which indicates the most serious public health hazard.

For the root cause and corrective actions, please click HERE