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 ApplicantProduct NameJanuary 19, 2021Jiangsu Hengrui MedicineLidocaine mussel protein spray agentJanuary 22, 2021BIOT BiologyGentamicin sulfate collagen spongeApril 2, 2021ARTIC VISIONPilocarpine ophthalmic solutionApril 2, 2021UCBStaccato alprazolamApril 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 ApplicationName of ApplicantProduct NameDecember 15, 2020Johnson & Johnson Vision Care (Shanghai) LtdSoft contact lensFebruary 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 repairFebruary 19, 2021YIMEIQIAntibacterial orthodontic appliancesMarch 18, 2021BIOHONGMicro-crosslinked sodium hyaluronate gel for injectionApril 7, 2021TuorenMedical masks infused with quaternary ammonium salt

Non-combination products registered as drugs

Date of ApplicationName of ApplicantProduct NameDecember 10, 2020Cutia Therapeutics (Wuxi) Co., LtdMinocycline hydrochloride foaming agentDecember 19, 2020Ocumension Therapeutics (Shanghai) Co., Ltd.Fluocinolone intravitreal implantJanuary 6, 2021Hengrui PharmaFluocinolone intravitreal implantJanuary 18, 2021Cutia Therapeutics (Wuxi) Co., LtdINS068 injection (pre-filled injection pen)February 9, 2021AbbVie Inc.Finasteride skin sprayFebruary 20, 2021ALPHAMAB (Jining)Risankizumab pre-filled portable dispenserFebruary 26, 2021Hangzhou Jiuyuan Gene Engineering Co .,Ltd.Recombinant human follicle stimulating hormone injectionMarch 2, 2021Allergan Consulting (Shanghai) Co., Ltd.Semaglutide injectionApril 30, 2021Hangzhou Jiuyuan Gene Engineering Co .,Ltd.Dexamethasone intravitreal implant (Ozurdex)May 8, 2021GeneScience Pharmaceuticals Co., Ltd.Liraglutide injection

Non-combination products registered as medical devices

Date of ApplicationName of ApplicantProduct NameDecember 10, 2020福州先亚生物科技有限公司Colonoscopy lubrication defoamerDecember 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.