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.
