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【EXPERT Q&A】What contents need to be submitted for the registration application of domestic Class II medical devices?

Drugdu.com expert’s response: The registration of Class II medical devices in China requires submission of key documents covering risk analysis, technical specifications, testing reports, clinical evaluation, labeling, quality management systems, and authenticity declarations. Detailed requirements are outlined below: I. Foundational Qualification Documents Medical Device Registration Application Form: Must include core details such as product name, model/specification, structural composition, and intended use, signed and stamped by the legal representative or responsible person. Enterprise Qualification Proof: Copy of the business license (valid within its term). Medical Device Manufacturing License (if applicable; the registered product must fall within the approved scope). Personnel Qualification Proof: Identity, educational, or professional title certificates for the legal representative, enterprise leader, and quality manager (the latter must have a medical device-related background). II. Product Technical Documentation Product Technical Report: Covers design principles, structural composition, manufacturing materials, performance indicators, and production processes. Must provide the product technical requirement number and explain the basis for key ...
- Source: drugdu
- 148
- July 25, 2025
Targeting tumor cell stemness may hold the key to treating colon cancer more effectively

Colon cancer remains a major global health concern, ranking third among the most diagnosed cancers and leading causes of cancer-related death worldwide. One critical factor that makes treating colon cancer challenging is the presence of cancer stem cells. Though typically present in small populations, these powerful cells drive tumor growth, resist standard treatments, and often contribute to relapse. They achieve this through their “stemness,” a set of properties that enable these cells to self-renew and differentiate into other cell types. Thus, understanding how stemness might be controlled at the molecular level is essential for developing effective therapies for colon cancer. Over the past two decades, researchers have identified several key molecules involved in both the development of the colon and the progression of colon cancer. Among them are CDX1 and CDX2, two homeobox transcription factors that help establish and maintain the identity of intestinal epithelial cells. Another example is ...
- Source: drugdu
- 249
- July 24, 2025
Pharmapack

Organiser: Informa Exhibitions Group Time：January 21-22, 2026 address：1, place de la Porte de Versailles, 75015 Paris, France Exhibition hall：Paris Expo Porte de Versailles Product range: Design and innovation of drug delivery systems, as well as raw materials (aluminum, cardboard, plastics, and glass) Transformers, packaging machinery, production equipment, automation and assembly line systems, product and packaging design services, thermoformed packaging for parts and components Aerosols, ampoules, sprays, blisters, medical devices, pharmaceutical packaging, vials, unit doses Labeling and identification, medical pumps, medical bags, syringes, pen injectors, reconstitution systems, tubes, and more Pharmaceutical subcontractors, printing and labeling, instruction manuals, brochures, sterilization technologies and services, control, tracking, and anti-counterfeiting measures, transportation materials and services About Pharmapack： Pharmapack, the France Paris Pharmaceutical Packaging Exhibition, is France’s largest and most authoritative pharmaceutical packaging exhibition. It brings together leading global industry designers, pharmaceutical manufacturers, suppliers of pharmaceutical packaging and delivery systems, and attracts decision-makers from pharmaceutical companies, ...
- Source: drugdu
- 177
- July 24, 2025
GI Cancers On The Rise Among Younger Adults

By Dennis Thompson HealthDay ReporterMONDAY, July 21, 2025 (HealthDay News) — GI cancers among people 50 and younger are rising at an alarming rate, increasing in the U.S. faster than any other type of early onset cancer, according to a pair of new studies. Cancers of the colon, stomach and esophagus have all increased in recent years, threatening the health of younger Americans, researchers say. Between 2010 and 2019, cases of young-onset GI cancers rose by nearly 15%, researchers reported in the British Journal of Surgery. “Colorectal cancer is the most common early onset GI cancer worldwide, accounting for more than half of the cases, but it is not the only GI cancer that is rising in younger adults,” said senior researcher Dr. Kimmie Ng, director of the Young-Onset Colorectal Cancer Center at the Dana-Farber Cancer Institute in Boston. “Unfortunately, pancreatic, gastric, and esophageal cancers are also increasing in young ...
- Source: drugdu
- 481
- July 23, 2025
FDA Elevates Dubai Chocolate Spread Recall to Class 1 Over Salmonella Risk

By Denise Mann HealthDay ReporterMONDAY, July 21, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has escalated the recall of a popular Dubai chocolate spread sold nationwide to its highest alert level due to salmonella risks. So far, four cases of salmonella and one hospitalization have been linked to the outbreak, according to the CDC. World Market initiated the voluntary recall of a batch of Emek Gıda’s pistachio-cocoa spread on July 14, after samples tested positive for salmonella contamination. Three days later, the recall was updated to a Class 1 alert. The Class 1 designation signifies a “reasonable probability” that consuming the spread could cause serious illness or death, according to the FDA. Salmonella can cause serious and potentially fatal infections in young children, the frail or elderly, and others with weakened immune systems, the FDA warned. Symptoms of Salmonella infection in healthy individuals may include fever, ...
- Source: drugdu
- 235
- July 23, 2025
WuXi Biologics’ Five Manufacturing Sites Pass U.S. FDA Pre-approval Inspections; First Commercial Prefilled Syringe Filling Plant Approved

On July 21, WuXi Biologics announced that its five manufacturing sites successfully passed the U.S. Food and Drug Administration (FDA) pre-approval inspection (PLI) with zero critical findings and zero data integrity issues. The nine-day FDA inspection covered WuXi Biologics ‘ quality management system and the entire production process of its two bulk drug manufacturing plants (MFG1 and MFG5) and three drug product manufacturing plants (DP1, DP2, and DP5) in Wuxi, China. As the company’s first commercial prefilled syringe (PFS) filling plant, DP5 passed the regulatory inspection for the first time, laying a solid foundation for it to provide high-quality prefilled syringe production solutions to global customers. https://finance.eastmoney.com/a/202507213462123078.html
- Source: drugdu
- 245
- July 23, 2025
Clinical trial of innovative drug for rosacea treatment of Taienkang has been accepted

On the evening of July 18, TaienkangAn announcement was released stating that the application for a Phase II/III seamless adaptive clinical trial for the rosacea indication of CKBA cream developed by the company’s holding subsidiary, Bo Chuang Park, had recently received an acceptance notice issued by the National Medical Products Administration. The announcement shows that rosacea is a chronic, recurrent inflammatory skin disease that occurs most frequently in women aged 20 to 50, with symptoms such as facial flushing, erythema, papules, pustules and telangiectasia. So far, there is no Class 1 innovative drug for the treatment of rosacea in China.Approved for marketing. According to Taienkang , the company’s CKBA cream is a major achievement of more than 20 years of basic research by Wang Honglin’s team at Shanghai Jiaotong University. It is the world’s first innovative small molecule drug targeting the T cell fatty acid metabolism pathway (by inhibiting the ...
- Source: drugdu
- 194
- July 23, 2025
Taking effect in 30 minutes, the domestically produced new ED drug Onvida® has been approved. Is the multi-billion dollar market about to undergo a change?

Recently, the official website of the State Food and Drug Administration announced that the Class 1 new drug Selenafil Hydrochloride Tablets (trade name: Onvida®) applied by Suzhou Wangshan Wangshui Biotechnology was officially approved for marketing for the treatment of male erectile dysfunction (ED). The research and development of Onvida® began ten years ago. Founded in 2013, Wangshan Wangshui Biopharmaceuticals, as the first biopharmaceutical company incubated by the Suzhou Achievement Transformation Center of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, set its sights on the ED treatment market, which was then monopolized by multinational pharmaceutical companies. The research team drew inspiration from flavonoid natural products, and after a large number of screening and structural optimization, they finally obtained a highly active and highly selective phosphodiesterase 5 (PDE5) inhibitor with independent intellectual property rights. In March 2016, the drug obtained a clinical trial approval; in February 2023, it completed ...
- Source: drugdu
- 1,418
- July 23, 2025
Giants increase investment, and triple antibody becomes a “new outlet”

Recently, AbbVie spent $700 million upfront to introduce IGI Therapeutics SA (IGI)’s new trispecific antibody drug ISB 2001, with exclusive rights to develop, manufacture and commercialize in North America, Europe, Japan and Greater China. According to the agreement, IGI will receive a $700 million upfront payment and is eligible to receive up to $1.225 billion in development, regulatory and commercial milestone payments, as well as tiered double-digit net sales royalties. According to public information, ISB 2001 is a trispecific antibody targeting CD38, BCMA and CD3. It is currently in Phase 1 clinical development for the treatment of relapsed/refractory multiple myeloma and has been granted orphan drug designation and fast track status by the FDA. Currently, a number of dual-antibody drugs targeting BCMA and CD3 have been approved for marketing for multiple myeloma, including Johnson & Johnson’s Tecvayli, Pfizer’s Elrexfio and Regeneron’s Lynozyfic. ISB 2001 adds CD38 to the combination to ...
- Source: drugdu
- 510
- July 23, 2025
【EXPERT Q&A】How should the clinical evaluation path for Class II active medical devices be selected?

Drugdu.com expert’s response: The selection of clinical evaluation pathways for Class II active medical devices should be based on product risk levels, technical characteristics, and data availability, with evaluations completed through three pathways: exemption from clinical trials, comparison with predicate devices, or clinical trials. The specific analysis is as follows: I. Core Pathway Selection Criteria Exemption from Clinical Trials Pathway Applicable Conditions: The product is listed in the Catalogue of Medical Devices Exempt from Clinical Evaluation and fully aligns with the descriptions in the catalogue. Key Operational Points: Submit comparative data between the product and the catalogue entries, along with a comparison statement with legally marketed medical devices already approved in China (covering fundamental principles, structural composition, performance requirements, etc.) to demonstrate equivalence. Typical Examples: Low- to moderate-risk products such as general surgical instruments and certain rehabilitation aids. Comparison with Predicate Devices Pathway Applicable Conditions: The product is essentially equivalent to a legally ...
- Source: drugdu
- 209
- July 23, 2025

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