The NMPA granted innovative device status to 27 medical devices from July to September 2023:
Cardiovascular
- Peripheral Thrombectomy Stent System
- Extracorporeal ventricular assist device
- Peripheral vein thrombectomy stent system
- Interventional ventricular assist device
- Transcatheter valve system
- Cardiac cryoablation system
- Implantable cardioverter defibrillator
- Disposable rotational coronary atherectomy device
- Interventional left ventricular assist system
- Minimally invasive myocardial rotational cutting system
- Abdominal aorta stent graft system
Chemistry
- Human CDO1/AJAP1/GALR1 gene methylation detection kit (fluorescence PCR method)
- Human DNA Methylation Detection Kit (Reversible End Termination Sequencing Method)
Dermatology
- Plasma skin treatment device
Gastroenterology/Urology
- Gastric tumor electronic endoscopic image-assisted detection software
- Disposable pressure monitoring pulsed electric field ablation catheter
- Disposable silicone catheter
General hospital
- Disposable magnetoelectric positioning pressure monitoring pulsed electric field ablation catheter
- Pulsed electric field ablation equipment
- Light-cured wound sealant
Neurology
- Near infrared light brain function therapy device
- Intracranial aneurysm interventional surgery simulation software
Oncology
- Boron neutron capture therapy system
- Prostate cancer magnetic resonance image-assisted diagnosis software
Ophthalmic
- Fundus image-assisted judgment software for glaucoma-like fundus changes
- Phakic intraocular lens
- Multifocal intraocular lens
Radiology
- Head and neck aneurysm CT angiography image-assisted detection software
Key Takeaways for Overseas Manufacturers
Only one out of seven medical devices granted Innovative Device Status (not approved yet) by NMPA in 2022 were imported. Since domestic and overseas manufacturers have equal opportunity for this program, U.S. and European companies may not be taking full advantage.
Overseas manufacturers have to bear in mind that:
- The NMPA gives overseas manufacturers equal opportunity for the fast-track channels. No difference as to the qualifications for domestic manufacturers vs. overseas ones;
- “Conditional Approval” applies for urgently-needed medical devices. NMPA issue the “Guideline on Conditional Approval for Medical Devices” on December 20, 2019. It specifies that devices and IVDs indicated for life-threatening illnesses can be granted “Conditional Approval”, if the benefits of the products overweigh the risks, and the manufacturers are committed to do further clinical research;
- They can initiate innovation approval applications at same time when applying China Patent & Trade Office coverage. Application does not have to be made after getting the patent;
- Having been granted “status” does not mean “approval”. With ‘front-of-queue’ priority, they still have to go through the normal review process.
China Med Device has translated “Innovation Approval Procedure for Medical Devices” and other official NMPA documents into English as a service for its clients. Email info@ChinaMedDevice.com for details.