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【EXPERT Q&A】What qualifications does a medical device company need to obtain?

Drugdu.com expert’s response: Medical device companies must obtain corresponding qualifications based on their business type (manufacturing or distribution) and product classification (Class I, II, or III). The details are as follows: I. Manufacturing Qualifications Class I Medical Devices Qualification Name: Class I Medical Device Production Filing Certificate Issuing Authority: Municipal-level drug regulatory administration (at the district level) Requirements: Possess compliant production facilities (e.g., cleanrooms) and equipment (e.g., calibrated instruments), along with quality management system documentation (e.g., quality manuals, work instructions). Submit materials including business license, proof of production site usage rights, and equipment inventory. Class II and Class III Medical Devices Qualification Name: Medical Device Manufacturing License Issuing Authority: Provincial drug regulatory administration (for Class II) or National Medical Products Administration (for Class III) Requirements: Production sites must meet cleanliness, temperature, and humidity standards, with advanced equipment subject to regular calibration. The quality management system must cover procurement, production, and ...
- Source: drugdu
- 89
- January 2, 2026
Jinghong Medical Secures Series A Strategic Financing, Co-led by Venture Capital and Binhu Industrial Group with FTEC Capital as Exclusive Financial Advisor

It was learned from Vcbeat on an exclusive basis that Jinghong Medical Technology Group, a flagship enterprise in the domestic medical sterilization and supply field, officially announced the successful completion of its Series A strategic financing recently. The financing round was jointly led by Wuxi Innovation Investment Group Co., Ltd. and Binhu Industrial Group, with follow-on investments from prestigious institutions such as Shanghai Digital Industry Group and Xiaoyar Capital. FTEC Capital acted as the sole financial advisor for this financing event. This milestone funding round not only embodies the capital market’s unwavering confidence in the medical sterilization and supply industry, but also indicates that Jinghong Medical has stepped into a new stage of accelerated development in its national chain deployment, technological upgrading and service scale expansion. Strong Rigid Demand in Sterilization & Supply Market, a Hundred-Billion-Yuan Sector According to the 2022-2028 Research and Development Prospect Report on China’s Third-party ...
- Source: drugdu
- 90
- January 1, 2026
Expofarma

Organiser：Mexican Pharmaceutical Association Time：April 15–17, 2026 Address：Conscripto 311, Colonia Lomas de Sotelo, Delegación Miguel Hidalgo, 11200, México D.F. Exhibition hall：Centro Banamex Product range: API (Active Pharmaceutical Ingredient) Equipment: Reaction equipment, drying equipment, crystallization equipment, centrifuges, extraction equipment, heat exchangers, storage equipment, filtration equipment, evaporation equipment, distillation equipment, screening machinery, sterilization equipment, filter press equipment, homogenizers, etc. Pharmaceutical Formulation Equipment: Pill-making machinery, ointment machinery, eye drop machinery, tablet machinery, tincture/syrup machinery, granule machinery, soft capsule (pill) machinery, aqueous injection machinery, hard capsule machinery, suppository machinery, oral liquid machinery, film-coating machinery, aerosol machinery, antibiotic powder/aqueous injection machinery, infusion machinery, tablet presses, coating machines, pharmaceutical filling machines, airflow pulverizers, pharmaceutical grinding mills, mechanical pharmaceutical crushers, ultrafine pulverizers, granulators, mixing equipment, bottle conveyors, bottle sorting machines, oscillating capping devices, feeding systems, etc. Pharmaceutical Packaging Machinery: Weighing equipment, bag packaging machines, pillow-type packaging machines, blister packaging machines, bottle filling lines, printers, labeling machines, cartoning ...
- Source: drugdu
- 90
- January 1, 2026
Harbour BioMed and Lannacheng Land Landmark Collaboration on Next-Generation RDC Drugs

December 29, 2025 — Harbour BioMed announced a long-term strategic collaboration with Yantai Lannacheng Biotechnology Co., Ltd. (Lannacheng). Leveraging their respective resources and strengths, the two parties will jointly advance the development of next-generation Radionuclide Drug Conjugates (RDCs). Compared with conventional radiotherapy, Radionuclide Drug Conjugates (RDCs) utilize tumor antigen-specific molecular ligands to precisely deliver radionuclides directly into tumor lesions for radiotherapy, thereby effectively minimizing damage to surrounding normal tissues. In contrast to Antibody-Drug Conjugates (ADCs), the radionuclides in RDCs can also exert cytotoxic effects on tumor cells adjacent to target cells and their microenvironment, even if these cells do not express the target antigen themselves. This confers a potential mechanistic advantage in overcoming tumor heterogeneity and drug resistance. Additionally, this technology holds promise for enabling theranostics (the integration of diagnosis and therapy). Harbour BioMed’s proprietary Harbour Mice® technology platform is capable of generating fully human monoclonal antibodies in both conventional ...
- Source: drugdu
- 93
- December 31, 2025
CAR-T Therapy Approved for Clinical Trials

On December 29, according to the official website of the Center for Drug Evaluation (CDE), Juventas Biotechnology’s HY001N cell injection has been approved for clinical trials, with the proposed indication being autoimmune hemolytic anemia (AIHA) that has failed at least three lines of therapy. It is worth noting that this is the company’s first CAR-T therapy developed based on its innovative, rapidly prepared NexT platform. CDE Official Website HY001N cell injection is the first product developed on Juventas innovative rapid NexT technology platform. Compared to traditional autologous CAR-T technology platforms, the rapid NexT process reduces the in vitro expansion and culture steps of CAR-T cells, shortening the in-plant production time from 9-14 days to less than 2 days. Patient waiting time is reduced by 50%, down to 10 days, and production costs are significantly lower than existing technologies. Simultaneously, the rapid CAR-T process significantly increases the proportion of T naïve cells in ...
- Source: drugdu
- 98
- December 31, 2025
The innovative anti-influenza drug, Mapaxixavir capsules (Yilikang®), was launched online on JD Health

On December 30th, Mapaxixavir Capsules (trade name: Yilikang®), a Class 1 innovative anti-influenza drug under Health-One Pharmaceutical Group, was launched online on the JD Health platform. This is an innovative oral treatment for influenza. Users can easily inquire and purchase it by searching for “Yilikang” on the JD APP, and quickly obtain cutting-edge antiviral treatment options. Influenza is an acute respiratory infectious disease caused by the influenza virus, and its harm is far greater than that of the common cold. Information released by the National Health Commission shows that influenza activity is currently at a high level nationwide. Influenza is highly contagious, has a rapid onset, and can cause symptoms such as high fever, body aches, and fatigue. It can also lead to serious complications such as pneumonia and myocarditis, posing a significant threat to the health of the entire population, especially children, the elderly, and patients with chronic diseases. ...
- Source: drugdu
- 92
- December 31, 2025
First Hexavalent Rotavirus Vaccine Completes First Dose Vaccination

Shanghai Securities News / China Securities Online (Reporter: Zhang Xue) — On December 26, the oral hexavalent rotavirus vaccine, independently developed by the Wuhan Institute of Biological Products under Sinopharm CNBG, completed its first dose vaccination. According to CNBG, this is the world’s first vaccine covering six rotavirus serotypes to officially enter the practical application stage. Rotavirus is a primary pathogen causing acute severe diarrhea in infants and young children, characterized by wide transmission and significant health risks. The oral hexavalent rotavirus vaccine administered in this first dose covers six major serotypes—G1, G2, G3, G4, G8, and G9—achieving full coverage of China’s currently dominant circulating G-type strains for the first time. Li Ruizhen, deputy chief physician of the Child Healthcare Department at Wuhan Children’s Hospital, pointed out that multivalent vaccines help expand the scope of immune protection and are of positive significance in reducing the occurrence of severe diarrhea and ...
- Source: drugdu
- 93
- December 31, 2025
Progress Made in Research on Treatment for Drug-Resistant Bacterial Meningitis

People’s Daily Online, Beijing, Dec. 30 (Reporter: Zhao Zhuaqing) — Bacterial meningitis poses a severe threat to human health. ESKAPE pathogens, a major cause of hospital-acquired infections, have been defined by the World Health Organization (WHO) as priority pathogens requiring critical or high-priority action. The blood-brain barrier (BBB) blocks nearly 100% of large molecules and 98% of small molecules from entering the brain, making the treatment of meningitis particularly difficult. While Host Defense Peptides (HDPs) and their mimetics are considered highly promising candidates against drug-resistant bacterial infections, their application in meningitis research has been hindered by weak broad-spectrum antibacterial activity or an inability to penetrate the BBB. The Suzhou Institute of Biomedical Engineering and Technology (SIBET) of the Chinese Academy of Sciences has proposed an innovative strategy: “using biguanide as a novel cationic side-chain group for HDP mimetics.” Leveraging the high charge density and strong phospholipid binding capacity of the ...
- Source: drugdu
- 85
- December 31, 2025
Fosun Pharma Commences Phase I Clinical Trial for Nuclear Medicine Project SRT-007

Beijing Business Today News (December 30): Fosun Pharma announced that its subsidiary, Chengdu Xingrui Jingxuan Biotechnology Co., Ltd., has initiated Phase I clinical trials in Mainland China (excluding Hong Kong, Macau, and Taiwan) for SRT-007, an integrated diagnostic and therapeutic (theranostic) nuclear medicine project. The indication is for the diagnosis and treatment of PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). According to the announcement, the theranostic project SRT-007 consists of two injections: Gallium [68Ga] PSMA-0057 (for diagnosis) and Lutetium [177Lu] PSMA-0057 (for treatment). Specifically, Gallium [68Ga] PSMA-0057 injection is a diagnostic radiopharmaceutical, while Lutetium [177Lu] PSMA-0057 injection is a therapeutic radiopharmaceutical. https://finance.eastmoney.com/a/202512303605807463.html
- Source: drugdu
- 84
- December 31, 2025
AmoyDx’s “Human BRCA1/BRCA2 Gene Mutation Detection Kit” Granted Approval

On December 30, AmoyDx (300685) announced that the company recently received the “Medical Device Registration Certificate of the People’s Republic of China” issued by the National Medical Products Administration (NMPA). The registration is valid from December 29, 2025, to December 28, 2030. The approved product is the “Human BRCA1/BRCA2 Gene Mutation Detection Kit (Reversible Terminator Sequencing),” a Class III medical device primarily used for the in vitro qualitative detection of gene mutations in prostate cancer patients. This kit marks the first domestic approval of a Homologous Recombination Deficiency (HRD) test for prostate cancer indications, offering comprehensive coverage of various mutation types. The product, along with its companion drug Niraparib and Abiraterone Acetate tablets, has been included in the National Reimbursement Drug List (NRDL). This integration creates a synergistic “Precision Testing + Medical Insurance Medication” system, which helps improve treatment accessibility for patients. In the first three quarters of 2025, AmoyDx ...
- Source: drugdu
- 82
- December 31, 2025

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