Introduction: Qualification landing, intelligent manufacturing sets sail! Inner Mongolia Jinyuankang Bioengineering Co., Ltd. welcomes another milestone in its development. All three self-developed liquid culture medium products have obtained the first category medical device product registration. The company has also been approved for the first category medical device production registration certificate, officially possessing full qualifications for compliant production and market-oriented supply of culture media!
Recently, with the approval of the Hohhot Municipal Administration and Government Service Bureau, Inner Mongolia Jinyuankang Bioengineering Co., Ltd. has received frequent good news: its RPMI-1640 culture medium and two cell culture media, totaling three liquid culture media products, have all successfully completed the filing of Class I medical device products (filing date May 28, 2026); On June 2, 2026, the enterprise officially obtained the "First Class Medical Device Production Filing Certificate" (filing number: Neihu Pharmaceutical Supervision Equipment Production Preparation No. 20260001), marking the implementation of dual filing of products and production in the field of in vitro diagnostic cell culture consumables by Jinyuankang, and the full chain compliance of products from research and development, mass production to clinical marketization has been connected to the National Medical Products Administration.
1、 Three products have been approved for filing, consolidating the matrix of cell culture consumables products
The filing information of the three liquid culture media that have been filed this time will be officially issued a filing number notification by the Hohhot Administrative Approval and Government Service Bureau. Specific filing details:
1. RPMI-1640 culture medium | Filing number: Neihu equipment preparation 20260002
2. Cell culture medium | Filing number: Inner respiratory equipment preparation 20260003
3. Cell culture medium | Filing number: Inner respiratory equipment preparation 20260004
The production address and enterprise registration address of the three products are unified as: No. 4, Block B, East Branch Road, Yulong Industrial Park, Yuquan District, Hohhot City, Inner Mongolia Autonomous Region, achieving integrated control of research and development and production at the same location.
According to the relevant classification requirements of the "Management Measures for Registration and Filing of In Vitro Diagnostic Reagents", the culture medium for this filing belongs to the first category of in vitro diagnostic medical devices. The product is a basic liquid cell culture medium, which is only used for cell proliferation and culture in vitro, without cell induction, differentiation, or screening functions. The cultured cells are limited to clinical in vitro diagnostic use and are widely applicable to laboratory departments of medical institutions, third-party medical laboratories, university research laboratories, and biopharmaceutical research and development enterprises. It is a core basic consumable for cell pathology, immune testing, and in vitro diagnostic experiments.
Jinyuankang has been deeply involved in the research and development of biological culture media for many years. Based on the technical accumulation of local biological research and development laboratories, the formula ratio of culture media and the quality control system of raw materials have been optimized. The self-developed liquid culture media has the advantages of high cell survival rate, strong batch stability, ready to use and convenient use, and controllable shelf life. It can adapt to the full range of clinical routine cell culture needs and fill the gap in the large-scale production of liquid culture media in Inner Mongolia.
2、 Obtained production registration and obtained the "pass" for compliant mass production
On June 2, 2026, Jinyuankang officially obtained the first category medical device production filing certificate (Neihu Drug Supervision Equipment Production Record No. 20260001), which was issued and stamped by the Hohhot Administrative Approval and Government Service Bureau. According to the Regulations on the Supervision and Administration of Medical Devices, the production record of Class I medical devices is the legal admission qualification for enterprises to legally produce medical device products. It represents that the enterprise's factory environment, production equipment, quality control system, professional technical team, and factory inspection conditions have all passed the compliance audit of the competent department, and have the ability to standardize the mass production of medical devices.
From then on, Jinyuankang has completed its product development phase and entered a new stage of independent large-scale production and national market supply: on the one hand, it can achieve independent mass production of three registered culture media, strictly controlling production costs and product quality; On the other hand, compliant products can officially enter the national medical device bidding and medical institution consumables procurement system, accelerating the localization and implementation process of local biological consumables in Inner Mongolia.
3、 Deeply cultivating the biotechnology industry in northern Xinjiang and empowering the development of Inner Mongolia's biopharmaceutical industry
Inner Mongolia Jinyuankang Bioengineering Co., Ltd. was established in 2005. It is a national high-tech enterprise specializing in the research and development, production, and application of animal serum, culture media, vaccine adjuvants, cell banks, and peripheral products. As a pioneer in the domestic serum industry, the company has always adhered to the business philosophy of technology, innovation, and quality, with the mission of promoting the development of the life and health industry, and is committed to providing Chinese "chips" for the field of biomedicine in China. Committed to becoming the world's number one "cell" service provider.
The implementation of dual product and production filing is not only an authoritative official certification of the company's research and development strength and quality control capability, but also an important achievement in the subdivision of the Hohhot biopharmaceutical industry ✅ For enterprises: Improve compliance qualifications, enrich core product lines, open up the national medical culture medium market space, and iteratively optimize new culture medium products based on the existing filing system, expanding the layout of in vitro diagnostic consumables; ✅ For the industry: Fill the gap in compliant production of local liquid cell culture media in Inner Mongolia, reduce regional medical institutions' dependence on purchasing consumables from other provinces, and help improve the in vitro diagnostic industry chain in northern Xinjiang; ✅ For customers: Provide localized, cost-effective domestic compliant training medium selection for hospitals and research institutes at all levels, shorten supply cycles, and optimize after-sales technical services.
4、 Future outlook: Based on compliance, we will continue to deepen our involvement in the domestic bio consumables market
Next, Jinyuankang will take this dual filing qualification as a new starting point:
1. Implement standardized mass production lines, optimize the mass production processes of three liquid culture media, and ensure stable mass production delivery;
2. Continuously invest in research and development, expand new cell culture media of different specifications and segmented uses, and expand the catalog of first-class medical device products;
3. Strictly adhere to the quality management standards for the entire life cycle of medical devices, rely on the geographical advantages of Hohhot, radiate to the medical markets in North China and Northwest China, and create a domestic high-quality in vitro diagnostic consumables independent brand in Inner Mongolia.
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