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【EXPERT Q&A】How to apply for medical device qualifications?

Drugdu.com expert’s response: The process of obtaining medical device qualifications involves multiple stages and stringent requirements, necessitating the preparation of corresponding materials and adherence to legal procedures based on the classification of medical devices (Class I, Class II, Class III) and the specific type of business operation (manufacturing or distribution). Below is a detailed explanation: I. Clarifying the Type of Qualification to Be Obtained Medical device qualifications are primarily categorized into manufacturing qualifications and distribution qualifications. These are further classified into Class I, Class II, and Class III based on the risk level of the medical devices. The requirements and procedures for obtaining qualifications vary across different categories. Class I Medical Devices: These pose a low risk and are subject to routine management. Generally, they only require filing and do not necessitate a license. Class II Medical Devices: These carry a moderate risk and require strict control and management. Distribution ...
- Source: drugdu
- 100
- June 6, 2025
4.1 billion US dollars! Thermo Fisher Scientific acquires Solventum’s purification and filtration business

On February 25th, Thermo Fisher Scientific (NYSE: TMO) announced that it has reached a final agreement with Solventum (NYSE: SOLV) to acquire Solventum’s purification and filtration business for approximately $4.1 billion in cash. The transaction is expected to be completed by the end of 2025. Affected by this transaction, the stock price of Thermo Fisher Scientific rose by 4%, and the stock price of Solventum rose by 10%. The transaction is expected to remain neutral on Solventum’s 2025 earnings per share (EPS) and is expected to bring in approximately $3.4 billion in net income, with Solventum’s plan primarily focused on reducing debt. This acquisition is expected to bring mid to high single digit organic growth to Thermo Fisher Scientific. By applying the PPI business system, the company will achieve strong profit expansion and significant synergies. In the first year after the completion of the transaction, it is expected that ...
- Source: drugdu
- 66
- June 5, 2025
COMPAMED

Organiser: COMPAMED Time：November 17–20, 2025 address：Messeplatz, Stockumer Kirchstraße 61, 40474 Düsseldorf, Germany Exhibition hall：Dusseldorf Exhibition Center Product range: Medical electronic instruments, ultrasonic instruments, X-ray equipment, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, hemodialysis equipment, anesthesia and respiratory equipment, etc. Disposable medical supplies, dressings and hygiene materials, various surgical instruments, etc. Hospital ward, operating room, and emergency room equipment, hospital office equipment, laboratory equipment, etc. Medical and healthcare devices, home healthcare products, physiotherapy, orthopedic technologies, etc. Information and communication technologies, medical services, and publications, etc. Laboratory equipment and technologies, etc. About COMPAMED： The COMPAMED trade fair in Düsseldorf, Germany, is the world’s largest and most authoritative exhibition for the medical manufacturing industry. Since its inception in 1992, it has grown into a renowned comprehensive medical exhibition globally, recognized as the world’s premier event for hospitals and medical devices. With its unparalleled scale and influence, COMPAMED ...
- Source: drugdu
- 79
- June 5, 2025
Gloria Pharmaceuticals and Eisai China Pharmaceuticals Signed a Marketing Service Agreement for Methylcobalamin Injection

On the evening of June 3, Gloria Pharmaceutical(002437) issued an announcement stating that the company’s wholly-owned subsidiary Tianjin Gloria Boda Technology Co., Ltd. (hereinafter referred to as “Tianjin Boda”) and Eisai (China) Pharmaceuticals Co., Ltd. (hereinafter referred to as “Eisai China Pharmaceuticals”) signed a “Marketing Service Agreement” for “Methylcobalamin Injection” (trade name: Mecobalamin). The agreement stipulates that Eisai China Pharmaceuticals authorizes Tianjin Boda to exclusively promote methylcobalamin injection in mainland China (excluding the Hong Kong Special Administrative Region, the Macao Special Administrative Region and Taiwan), and the authorization period is from June 1 to the expiration date of the agreement. Tianjin Boda is responsible for providing marketing services and other related services for the product in the above-mentioned regions. Gloria Pharmaceutical said that Tianjin Boda’s promotion of methylcobalamin injection will further enrich the company’s product pipeline and is expected to increase the company’s operating income and profits; in addition, it ...
- Source: drugdu
- 87
- June 4, 2025
Iopromide Injection Obtains Drug Registration Certificate

Starry Pharmaceutical announced on the evening of June 4 that its wholly-owned subsidiary Shanghai Sital recently received the “Drug Registration Certificate” for iopromide injection approved and issued by the National Drug Administration. This drug is indicated for use in diagnostic medication. It is used in blood vessels and body cavities. Computer X-ray tomography (CT) enhancement, arterial angiography and venography, arterial/venous digital subtraction angiography (DSA), especially suitable for cardiovascular angiography, intravenous urography, endoscopic retrograde pancreatocholangiopancreatography (ERCP), arthrography and other body cavity examinations, and cannot be used in the sheath. https://finance.eastmoney.com/a/202506043421771579.html
- Source: drugdu
- 87
- June 4, 2025
A new nuclear medicine company plans to go public in Hong Kong

In May, the Hong Kong-listed innovative drug sector was extremely lively. Rongchang Biopharma raised nearly 800 million yuan through allotment financing, Hengrui Medicine and Paige Biopharma were listed one after another, and Xiantong Pharmaceutical also submitted an application for listing. Xiantong Pharmaceutical is a new generation leading enterprise in the field of nuclear medicine. Its prospectus shows that its pre-IPO valuation has reached 5.188 billion yuan, and its cumulative financing has exceeded 2.9 billion yuan. With this IPO, Xiantong Pharmaceutical is expected to broaden its financing channels and accelerate the research and development and commercialization of its nuclear medicine products, which also marks a key step in the capitalization process of China’s nuclear medicine industry. Four core pipelines In the past two years, Xiantong Pharmaceutical’s operating income was RMB 10.232 million and RMB 44.064 million respectively, and the corresponding net losses were RMB 309 million and RMB 156 million respectively. ...
- Source: drugdu
- 95
- June 4, 2025
Hengrui is about to acquire the “first domestic

Chinese pharmaceutical companies represented by Hengrui Medicine and Ipomoea australis are actively planning the clinical development of URAT1 inhibitors. With the acceleration of the research process, a new generation of highly effective and low-toxic gout treatment drugs is expected to be quickly launched on the market, promoting innovation in the field of gout treatment. Significant clinical need Hyperuricemia is a metabolic syndrome caused by purine metabolism disorder. Its clinical diagnosis requires that the blood uric acid level of an adult exceeds 420μmol/L (7mg/dl) twice on different days. Gout is a crystal-related arthropathy. As a common metabolic rheumatic disease, its pathological basis is hyperuricemia – abnormal purine metabolism or reduced uric acid excretion causes increased blood uric acid, which in turn leads to the deposition of monosodium urate crystals. The current treatment of chronic hyperuricemia and gout mainly revolves around two core mechanisms: inhibiting uric acid synthesis and promoting uric acid ...
- Source: drugdu
- 77
- June 4, 2025
Antibiotic-Resistant Gonorrhoea Cases Rise in England

The UK Health Security Agency (UKHSA) has published the latest figures on sexually transmitted infections (STIs) in England. They show an ongoing increase in cases of antibiotic-resistant gonorrhoea, despite a general decline in gonorrhoea infections. The figures showed a 16% reduction in gonorrhoea diagnoses generally, with 71,802 cases recorded in 2024 compared with 85,370 in 2023. The agency described this as encouraging and noted that the decline was most pronounced among young people aged 15-24 years, with diagnoses falling by more than a third (36%). Antibiotic Resistance a Growing Concern Despite the overall decline, the UKHSA warned of a “concerning acceleration” in cases of antibiotic-resistant gonorrhoea. While most infections remain treatable, resistance to ceftriaxone — the first-line treatment — poses significant clinical challenges. Ceftriaxone resistance remains uncommon in the UK but is frequently reported in the Asia-Pacific region. The UKHSA noted that many of the resistant cases had links ...
- Source: drugdu
- 60
- June 4, 2025
How Can A Daily Cup Of Beans Improve Your Health?

By Dennis Thompson HealthDay ReporterTUESDAY, June 3, 2025 (HealthDay News) — Beans aren’t just the musical fruit, they can be pure magic for your health, a new study says. Eating a daily cup of beans significantly improved the health of a small group of people with prediabetes – a condition in which elevated blood sugar levels have nearly caused type 2 diabetes. “Our study found that bean consumption helped significantly lower cholesterol and reduce inflammation in people with prediabetes, although glucose levels were not changed,” researcher Morganne Smith, a doctoral candidate at the Illinois Institute of Technology, said in a news release. This is good news, as people with prediabetes often have high cholesterol and chronic inflammation, both of which increase their risk of other chronic health problems like heart disease, Smith said. For the study, researchers randomly assigned 72 people to eat black beans, chickpeas or rice for ...
- Source: drugdu
- 60
- June 4, 2025
【EXPERT Q&A】Can medical devices be contracted for production?

Drugdu.com expert’s response: Medical devices can indeed be entrusted for production, but strict compliance with relevant regulatory requirements is essential. Below is a detailed analysis: I. Regulatory Basis and Fundamental Requirements According to the Regulations on the Supervision and Administration of Medical Devices and related supporting documents, medical device registrants and record-holders (hereinafter referred to as “registrants”) may entrust qualified enterprises to manufacture medical devices. The core principle of entrusted production is that registrants bear primary responsibility for the quality and safety of the products, while the entrusted party must organize production in accordance with regulations, standards, and the entrustment agreement, and accept supervision from the registrant. II. Key Restrictive Conditions Prohibited Entrusted Production Catalog: High-risk implantable medical devices (such as cardiac pacemakers, artificial joints, etc.) are not allowed to be entrusted for production. The specific catalog is formulated and dynamically adjusted by the National Medical Products Administration (NMPA). Given the direct implantation ...
- Source: drugdu
- 75
- June 4, 2025

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