NMPA Approved 102 Medical Devices in July 2020
In July 2020, NMPA has approved a total of 102 medical devices. 73 of them are domestic Class III medical devices, 11 of them are imported Class III medical devices, 17 of them are imported Class II medical devices and one of them is a Taiwan medical device.
Link: https://www.nmpa.gov.cn/xxgk/ggtg/ylqxpzhzhcchpgg/20200821110954106.html
Please find the approved imported medical devices in July 2020 as below. If you want to know
more about your device category, clinical pathways, predicate information and other related to
your China business, please do not hesitate to contact us at info@chinameddevice.cn.
Approved Imported Medical Devices in July 2020
| No. |
Product Name |
Registrant Name |
Certificate Number |
| Imported Class III Medical Devices |
| 1. |
cobas® HIV-1 for use on the cobas® 4800 System |
Roche Diagnostics GmbH |
国械注进20203400341 |
| 2. |
High Intensity Focused Ultrasound System |
SonaCare Medical, LLC |
国械注进20203010342 |
| 3. |
High-frequency Surgery System |
KARL STORZ SE & CO. KG |
国械注进20203010343 |
| 4. |
Advisor High Density Grid Mapping Catheter, Sensor Enabled |
St. Jude Medical |
国械注进20203070344 |
| 5. |
Implantable Pacemaker |
Medtronic Inc. |
国械注进20203120345 |
| 6. |
EmbryoGlue® |
Vitrolife Sweden AB |
国械注进20203180350 |
| 7. |
Sterile hypodermic needles for single use |
BECTON DICKINSON S.A. |
国械注进20203140351 |
| 8. |
ELUVIA OVER-THE-WIRE Drug-Eluting Vascular Stent System |
Boston Scientific Corporation |
国械注进20203130358 |
| 9. |
Roxolid Implant |
Institut Straumann AG |
国械注进20203170359 |
| 10. |
BD PureHub™ Disinfecting Cap |
Becton, Dickinson and Company |
国械注进20203030360 |
| 11. |
The absorbable polymer coated Sirolimus eluting coronary stent system |
Micell Technologies Ireland Limited |
国械注进20203030364 |
| Imported Class II Medical Devices |
| 12. |
Clinician Programmer |
Medtronic Inc. |
国械注进20202120339 |
| 13. |
Surgical Microscope |
Carl Zeiss Meditec AG |
国械注进20202060340 |
| 14. |
SmearClear |
Ormco Corporation also trading as SybronEndo |
国械注进20202170346 |
| 15. |
Orthodontic Buccal Tubes precoated with APC™ Flash-Free Adhesive |
3M Unitek Corporation |
国械注进20202170347 |
| 16. |
Embryo culture dish |
Vitrolife A/S |
国械注进20202180348 |
| 17. |
Rotator cuff stapler |
MININVASIVE LTD. |
国械注进20202040349 |
| 18. |
VITROS Chemistry Products Electrolyte Reference Fluid (ERF) 300 |
Ortho-Clinical Diagnostics, Inc. |
国械注进20202400352 |
| 19. |
Elecsys IGFBP-3 |
Roche Diagnostics GmbH |
国械注进20202400353 |
| 20. |
VITROS Chemistry Products Electrolyte Reference Fluid (ERF) 800 |
Ortho-Clinical Diagnostics, Inc. |
国械注进20202400354 |
| 21. |
Elecsys Anti-TSHR |
Roche Diagnostics GmbH |
国械注进20202400355 |
| 22. |
Access Estradiol |
Beckman Coulter, Inc. |
国械注进20202400356 |
| 23. |
Procalcitonin (PCT) |
Immunotech SAS, A Beckman Coulter Company |
国械注进20202400357 |
| 24. |
Washer/Disinfector |
Miele & Cie. KG |
国械注进20202110361 |
| 25. |
Light Source |
Richard Wolf GmbH |
国械注进20202060362 |
| 26. |
Delivery Bed |
Hill-Rom, Inc. |
国械注进20202180363 |
| 27. |
VITROS Chemistry Products ALT Slides |
Ortho-Clinical Diagnostics, Inc. |
国械注进20202400365 |
| 28. |
Elecsys IGFBP-3 |
Roche Diagnostics GmbH |
国械注进20202400366 |
| Hong Kong, Macao or Taiwan Medical Device |
| 29. |
Resorbable Bone |
Xile Medical Equipment Co., LTD |
国械注许20203130011 |
|
