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  • Drug-device combination products in 2021: List of Classification Results for the first batch

Drug-device combination products in 2021: List of Classification Results for the first batch

Monday, 26 July 2021 / Published in Medical Device, News, NMPA Registration in China

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 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 Name
January 19, 2021Jiangsu Hengrui MedicineLidocaine mussel protein spray agent
January 22, 2021BIOT BiologyGentamicin sulfate collagen sponge
April 2, 2021ARTIC VISIONPilocarpine ophthalmic solution
April 2, 2021UCBStaccato 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 ApplicationName of ApplicantProduct Name
December 15, 2020Johnson & Johnson Vision Care (Shanghai) LtdSoft 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, 2021YIMEIQIAntibacterial orthodontic appliances
March 18, 2021BIOHONGMicro-crosslinked sodium hyaluronate gel for injection
April 7, 2021TuorenMedical masks infused with quaternary ammonium salt

Non-combination products registered as drugs

Date of ApplicationName of ApplicantProduct Name
December 10, 2020Cutia Therapeutics (Wuxi) Co., LtdMinocycline hydrochloride foaming agent
December 19, 2020Ocumension Therapeutics (Shanghai) Co., Ltd.Fluocinolone intravitreal implant
January 6, 2021Hengrui PharmaFluocinolone intravitreal implant
January 18, 2021Cutia Therapeutics (Wuxi) Co., LtdINS068 injection (pre-filled injection pen)
February 9, 2021AbbVie Inc.Finasteride skin spray
February 20, 2021ALPHAMAB (Jining)Risankizumab pre-filled portable dispenser
February 26, 2021Hangzhou Jiuyuan Gene Engineering Co .,Ltd.Recombinant human follicle stimulating hormone injection
March 2, 2021Allergan Consulting (Shanghai) Co., Ltd.Semaglutide injection
April 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 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.

Tagged under: Combination Products, Drug device combination products

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