New Certificates Land Densely in July: Fuerjia and Aimeike Obtain Certificates One After Another, Medical Dressing Track Enters the "Multi-Component Compounding" Era

July isn't over yet, and the medical dressing and medical aesthetics tracks have already seen several significant registration certificates issued in succession.

Fuerjia obtained its 5th Class II certificate on July 20, Aimeike obtained its Class III certificate for temporal region filling on July 28, and combined with the June data released by the National Medical Products Administration on July 15 — 323 medical device products approved for registration in a single month, a figure that is again higher than the same period last year.

Friends in the OEM business should be concerned about one question: Behind these new certificates, which direction is the industry heading?

I. Overview of Key New Certificates in July

First look at the data, then look at the trends.

Fuerjia: Medical Sodium Hyaluronate Ectoin Repair Patch

• Registration Certificate Number: Hei Xie Zhu Zhun 20262140022
• Approval Date: July 20, 2026
• Valid Until: July 19, 2031
• Product Classification: Class II Medical Device
• Scope of Application: Care of small wounds, abrasions, cuts, as well as non-chronic wounds and surrounding skin after laser, photon, chemical peel, and minimally invasive cosmetic procedures

This is the 5th Class II medical device registration certificate obtained by Fuerjia. Previously, it had already obtained 4 certificates for medical sodium hyaluronate repair patches, repair solutions, recombinant type III humanized collagen patches, and medical trehalose repair patches.

Note one detail: This new product uses a "sodium hyaluronate + ectoin" dual-component compounding formula, not a single-component approach. Sodium hyaluronate provides a physical barrier, while ectoin is responsible for repairing cell damage caused by light damage and inflammation.

Aimeike: Medical Cross-linked Sodium Hyaluronate - Hydroxypropyl Methylcellulose Gel

• Registration Certificate Number: Guo Xie Zhu Zhun 20263131539
• Approval Date: July 28, 2026
• Valid Until: July 27, 2031
• Product Classification: Class III Medical Device
• Scope of Application: Injection into the supraperiosteal layer of the temporal region to improve mild to moderate temporal depression in adults

This is a Class III certificate, with an approval difficulty several orders of magnitude higher than Class II. The product uses a "cross-linked sodium hyaluronate + hydroxypropyl methylcellulose (HPMC)" dual-material system. The addition of HPMC is mainly to adjust the rheological properties of the gel, making injection feel smoother and providing more lasting support.

Yahuilong: 6 Microfluidic Chemiluminescence Reagents Collectively Approved

Shenzhen Yahuilong Biotechnology Co., Ltd. recently obtained 6 Class II registration certificates issued by the Guangdong Provincial Medical Products Administration, covering high-sensitivity troponin I, N-terminal pro-B-type natriuretic peptide, creatine kinase isoenzyme MB, myoglobin, B-type natriuretic peptide, and D-dimer assay kits, with registration certificates valid until July 2031. These products are the implementation results of a key research project under the national "14th Five-Year Plan."

June Overview: 323 Products Approved in a Single Month

According to Announcement No. 65 of 2026 by the National Medical Products Administration, a total of 323 medical device products were approved for registration in June 2026, including 282 domestic Class III, 30 imported Class III, 10 imported Class II, and 1 from Hong Kong, Macao, or Taiwan. In vitro diagnostic products accounted for 52.

II. 3 Trends Worth Noting for OEM Bosses

Now that we've reviewed the data, let's talk about the trends.

Trend 1: The Single-Component Era Is Over; "Compounding" Is the Key to Obtaining Certificates

Fuerjia's new product uses sodium hyaluronate + ectoin, and Aimeike uses cross-linked sodium hyaluronate + HPMC — both are dual-component or even multi-component formulas.

The reason is simple: Class II certificates for single-component sodium hyaluronate are already too numerous, and the track is crowded. To stand out from a pile of "medical sodium hyaluronate repair patches," differentiated compounding is essential.

For OEM factories, this means formulation development capabilities need to keep pace. When clients come to you, they're not just asking you to fill a bottle with sodium hyaluronate — they need you to formulate stable systems combining new raw materials like ectoin, recombinant collagen, and mussel adhesive protein with the base matrix.

Trend 2: The Cosmetics-Medical Devices Symbiosis Route Is Becoming Increasingly Solid

Fuerjia states it very plainly: "Technology-driven, cosmetics and medical devices in symbiosis." On one hand, it obtains medical device registration certificates; on the other, it develops functional skincare products, running both lines in parallel.

In Q1 2026, Fuerjia's revenue was RMB 548 million, up 82.12% year-on-year; net profit attributable to shareholders was RMB 172 million, up 87.73% year-on-year. This growth rate shows that the "cosmetics + medical devices" combination punch is indeed effective.

For OEM factories, this means your clients may need you to handle both medical device registration and cosmetic filing simultaneously. Factories that can manage both systems will see significantly more orders than those that only handle one.

Trend 3: The Medical Aesthetics Filler Track Is Starting to Compete on "New Materials"

This time, Aimeike didn't rely solely on traditional cross-linked hyaluronic acid; it added HPMC. This isn't the first time — as early as 2025, several companies were adding PLLA microspheres and PCL microspheres to hyaluronic acid gels.

The compounding route of new materials + classic matrix is the mainstream direction for Class III medical aesthetics certificate applications over the next 3 years. OEM friends who only focus on hyaluronic acid raw solution may miss out on a new wave of order opportunities.

III. How OEM Factories Can Capture This Demand

Here are 3 practical suggestions.

First, build a "compounding formula library." Organize proven compounding systems such as sodium hyaluronate + ectoin, sodium hyaluronate + recombinant collagen, and trehalose + mussel adhesive protein into standardized formulation modules. When clients come in, you can modify existing modules directly, which is 3 times faster than starting from scratch.

Second, calculate the Class II certificate registration cycle clearly. From formulation confirmation to obtaining the registration certificate, the normal cycle is 6-9 months. If biocompatibility testing and stability testing are involved, it may take more than 12 months. If a brand initiates a project in July and wants the certificate by October, that timeline is unrealistic. OEM factories should clearly communicate the registration cycle at the quotation stage to avoid disputes later.

Third, prepare formulation stability data in advance. Brands need 3-month accelerated stability and 6-month room-temperature retention sample data for registration. If OEM factories can generate stability data for commonly used formulations in advance, brands won't have to wait when selecting formulations — they can directly use existing data for application. The time saved is competitiveness.

Data sources: National Medical Products Administration Announcement No. 65 of 2026, Fuerjia announcement dated July 22, Aimeike announcement dated July 29, and Yahuilong announcement. The above information is compiled based on public materials and does not constitute investment advice.