NMPA issued a notice on March 17 to solicit the content input on four registration review guidelines. “Domestic and international manufacturers, research institutions, and clinical institutions with relevant work experience are encouraged to participate”, says the NMPA. Information Form needs to be submitted by April 7, 2025.
The four proposed documents are listed below:
- Guideline on Intravascular Ultrasound Diagnostic Equipment
- Guideline on Cardiac Electrophysiological Mapping Equipment and Accessories
- Guideline on Cardiac Pulsed Field Ablation Equipment
- Guideline on Laparoscopic Surgical Systems – Part 6: Model Study
Leading Companies
The four guidelines involve a wide range of global manufacturers which have devices registered in China, according to NMPA database. China Med Device, LLC suggest the following companies to be informed with and participate the guideline formulation.
Intravascular Ultrasound Diagnostic Equipment (IVUS)
- Boston Scientific
- Volcano Corporation
Cardiac Electrophysiological Mapping Equipment
- Abbott Medical
- Boston Scientific
- Philips Medical
Cardiac Pulsed Field Ablation Equipment
- Medtronic
- FARAPULSE
- Biosense Webster
Laparoscopic Surgical Systems
- Intuitive Surgical
- ConMed Corporation
- Olympus Winter & Ibe
- SCHÖLLY FIBEROPTIC
- XION
- ORIONPAX MEDICAL SURGERY
- Arthrex
- Henke-Sass, Wolf