There have been 32 innovation approvals granted by the NMPA in 2022. Overseas manufacturer Medtronic, Ethicon and BioFire Diagnostics are on the list. Cardiovascular, gastro/urology, neurology, and radiology devices are among the most, scoring 8, 7, 6, 6 approvals respectively.
The “Innovation Approval Procedure for Medical Devices” lists four criteria for domestic or imported Class II / Class III medical devices:
- Provide significant clinical application value,
- Own valid invention patent and have China Patent & Trade Office coverage,
- Complete the preliminary study on a prototype with traceable data, and
- Have an authorized in-country legal entity.
Takeaways for Manufacturers
If the innovation statuses is granted (which does not mean “approval”), the device will be allocated to the “front-of-queue” priority throughout the registration process.
The granted priority affects the classification determination, pre-clinical testing, QMS auditing, and NMPA reviewing/approving processes. Meanwhile, a specially assigned NMPA officer would check in and provide guidance throughout the expedited process.
Overseas manufacturers should bear in mind that:
- NMPA gives overseas manufacturers equal opportunity for the innovation channel. The qualifications are the same for domestic manufacturers as for overseas manufacturers.
- “Conditional Approval” applies for urgently needed medical devices. NMPA issued 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 product overweigh the risks and the manufacturers are committed to doing further clinical research post market approval.
China Med Device has summarized NMPA innovation approvals into a table below. Contact us at info@ChinaMedDevice.com to get the full information of any device you are interested in.
|Indication||Device Name (English)||Company||Domestic/Imported|
|Cardiovascular||Thoracic aortic stent system||Hangzhou Weiqiang||Domestic|
|Cardiovascular||Transcatheter Implantable Leadless Pacing System||Medtronic||Imported|
|Cardiovascular||Transcatheter prosthetic pulmonary valve system||Hangzhou Qiming||Domestic|
|Cardiovascular||Implantable Left Ventricular Assist System||Hangtian Taixin||Domestic|
|Cardiovascular||Flow-directing dense mesh stent||Accu Medical||Domestic|
|Cardiovascular||Left atrial appendage occluder system||Hangzhou Denuo Medical||Domestic|
|Cardiovascular||Intravascular ultrasound diagnostic equipment||Shenzhen Kaili Bio||Domestic|
|Cardiovascular||Single-use intravascular ultrasound diagnosis catheter||Shanghai Aisheng Bio||Domestic|
|Ear, Nose, and Throat||ENT dual-source cone beam computed tomography equipment||Beijing Langshi Instrument||Domestic|
|Gastroenterology and Urology||Digestive tract vibrating capsule system||Shanghai Anhan Medcal||Domestic|
|Gastroenterology and Urology||Ultrasound diagnostic equipment for gastrointestinal endoscopy||Beijing Huake Chuangzhi||Domestic|
|Gastroenterology and Urology||Disposable cryoablation balloon catheter||Ningbo Shengjiekang||Domestic|
|Gastroenterology and Urology||Laparoscopic surgery system||Suzhou Kangduo Robotics||Domestic|
|Gastroenterology and Urology||Intestinal polyps are assisted by electronic colonic endoscopic images||Chengdu weishi Medical||Domestic|
|Gastroenterology and Urology||Oxidized Regenerated Cellulose (ORC) powder||Ethicon||Imported|
|Gastroenterology and Urology||Anastomosis reinforcement patch||Beijing Bohui Biotech||Domestic|
|Hematology||Artificial blood vessels||Jiangsu Baiyouda||Domestic|
|Microbiology||Encephalitis/meningitis multiple pathogen nucleic acid combination detection kit||BioFire Diagnostics||Imported|
|Neurology||Dual-channel implantable deep brain stimulation system||Beijing Pinchi Medical||Domestic|
|Neurology||Navigation and positioning system for neurosurgery||Beijing Huake Precision||Domestic|
|Neurology||Implantable spinal cord stimulation system||Beijing Pinchi Medical||Domestic|
|Neurology||Implantable rechargeable spinal cord stimulator||Beijing Pinchi Medical||Domestic|
|Neurology||Patient Programmable Charger||Beijing Pinchi Medical||Domestic|
|Neurology||Intracranial Aneurysm Surgery Planning Software||Qianglian Zhichuang||Domestic|
|Ophthalmic||Aspheric diffractive multifocal intraocular lens||Aibonuode Meditech||Domestic|
|Orthopedic||Hip replacement surgery navigation and positioning system||Hangzhou Jiajian Robotics||Domestic|
|Radiology||CT image-assisted triage software for intracranial hemorrhage||United Imaging||Domestic|
|Radiology||Mobile head and neck MRI system||Foshan Ruijiatu||Domestic|
|Radiology||Magnetic resonance imaging system||Xingaoyi Medical Equipment||Domestic|
|Radiology||Disposable Intravascular Imaging Catheter||Hangzhou Weiqiang||Domestic|
|Radiology||Intravascular imaging equipment||Beijing Quanjing Hengsheng||Domestic|
|Radiology||Gamma Beam Stereotactic Radiation Therapy System||Xi’an Daxi||Domestic|