Anyone in the medical device registration industry knows that getting a certificate can't be rushed—from project initiation to supplementary review to approval, it takes at least half a year and up to two or three years. But Hunan Yian Biological has been moving fast, obtaining two certificates in a row in May.
First, the one that may attract more attention: Medical radiation protective agent (Xiangxie Zhuzhun 20252060470), approved on May 27.
What's interesting about this product? Its core ingredient is superoxide dismutase (SOD), taking a dual approach of antioxidant + physical barrier. Simply put, free radicals generated by radiotherapy can damage skin and mucosal tissues. SOD is responsible for clearing these free radicals, while the mineral oil and polysiloxane system forms a physical barrier on the outside. The formula also includes excipients such as curcumin, glycerin, and butylene glycol. The overall approach is quite clear.
The intended use states: "To prevent and alleviate damage to skin and mucosal tissues caused by free radicals generated by medical radiation and other physicochemical factors." Which departments use it? Radiation oncology, oncology, and nuclear medicine—these places deal with radiation every day, so protective agents are a necessity.
Now the second one: Medical recombinant collagen lyophilized fiber (Xiangxie Zhuzhun 20252140492), approved on May 30.
The dosage form is relatively novel—lyophilized fiber. Ingredients include recombinant collagen, mannitol, trehalose, bioglass, lactic acid, and carboxymethyl cellulose. Type I is a combination of bottle A (lyophilized product) + bottle B (purified water) + dropper; Type II is lyophilized product + glass bottle. It is used for covering non-chronic wounds such as small wounds, abrasions, and cuts.
As of now, Qichacha data shows that Hunan Yian holds 32 valid registration certificates, covering categories such as wound dressings (14 items), hemostatic materials (7 items), sodium hyaluronate series (4 items), recombinant protein series (4 items), and oral/ENT materials (3 items), among others. In addition, there are 5 certificates with Qiongxie Zhuzhun (Hainan medical device registration) in Hainan associated with Yian through commissioned manufacturing.
Here's a detail: both certificates are valid for 5 years, until 2030. After obtaining the certificate, there is still an advertising review process to go through. The advertising review approval for the radiation protective agent was obtained on July 1, 2026.
As a contract manufacturer, the number of registered certificates directly determines how many SKU options can be offered to clients. With 32 certificates and five major categories—this is a solid foundation in the circle of functional skincare and medical device OEM.
