Monday, 26, July, 2021
/ Published in China, Medical Devices, News
Drug-device combination products in 2021: List of Classification Results for the first batch
On July 7, 2021, the NIFDC (National Institute for Food and Drug Control) issued the first round of classification results in 2021 for drug-device combination product applications. The classification results cover 22 product applications from December 1, 2020, to May 31, 2021 as below. Given the increasing number of drug-device combination products, the list may be helpful as a reference point for registration and/or development of similar devices.
Drug-based combination products
| Date of Application | Name of Applicant | Product Name |
| January 19, 2021 | Jiangsu Hengrui Medicine | Lidocaine mussel protein spray agent |
| January 22, 2021 | BIOT Biology | Gentamicin sulfate collagen sponge |
| April 2, 2021 | ARTIC VISION | Pilocarpine ophthalmic solution |
| April 2, 2021 | UCB | Staccato alprazolam |
| April 8, 2021 | 北京红方医疗器械有限公司 | First aid hemostatic agent |
Medical device-based combination products
| Date of Application | Name of Applicant | Product Name |
| December 15, 2020 | Johnson & Johnson Vision Care (Shanghai) Ltd | Soft contact lens |
| February 6, 2021 | 北京奥斯特赛医学科技有限 公司 | Recombinant human bone morphogenetic proteins-2（rhBMP-2) for bone repair |
| February 19, 2021 | YIMEIQI | Antibacterial orthodontic appliances |
| March 18, 2021 | BIOHONG | Micro-crosslinked sodium hyaluronate gel for injection |
| April 7, 2021 | Tuoren | Medical masks infused with quaternary ammonium salt |
Non-combination products registered as drugs
| Date of Application | Name of Applicant | Product Name |
| December 10, 2020 | Cutia Therapeutics (Wuxi) Co., Ltd | Minocycline hydrochloride foaming agent |
| December 19, 2020 | Ocumension Therapeutics (Shanghai) Co., Ltd. | Fluocinolone intravitreal implant |
| January 6, 2021 | Hengrui Pharma | Fluocinolone intravitreal implant |
| January 18, 2021 | Cutia Therapeutics (Wuxi) Co., Ltd | INS068 injection (pre-filled injection pen) |
| February 9, 2021 | AbbVie Inc. | Finasteride skin spray |
| February 20, 2021 | ALPHAMAB (Jining) | Risankizumab pre-filled portable dispenser |
| February 26, 2021 | Hangzhou Jiuyuan Gene Engineering Co .,Ltd. | Recombinant human follicle stimulating hormone injection |
| March 2, 2021 | Allergan Consulting (Shanghai) Co., Ltd. | Semaglutide injection |
| April 30, 2021 | Hangzhou Jiuyuan Gene Engineering Co .,Ltd. | Dexamethasone intravitreal implant (Ozurdex) |
| May 8, 2021 | GeneScience Pharmaceuticals Co., Ltd. | Liraglutide injection |
Non-combination products registered as medical devices
| Date of Application | Name of Applicant | Product Name |
| December 10, 2020 | 福州先亚生物科技有限公司 | Colonoscopy lubrication defoamer |
| December 10, 2020 | 福州先亚生物科技有限公司 | Gastroscopy lubrication defoamer |
By Colleen Xu and Jacky Li. Contact Cisema if you would like to learn more.
