media – Page 5 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】How to apply for a drug business license? What conditions are needed?

Drugdu.com expert’s response: The process and requirements for obtaining a Pharmaceutical Trading License are as follows: I. Application Process 1. Preparation of Application Materials Pharmaceutical Trading License Application Form: Fill in the enterprise’s basic information and application details truthfully. Copy of the Enterprise’s Business License or Name Pre-approval Notice. Personnel Qualification Certificates: Identity certificates, academic certificates, and professional title certificates of the legal representative, enterprise leader, and quality leader. The quality leader must provide a licensed pharmacist registration certificate (for retail enterprises, the quality leader must be a licensed pharmacist). Qualification certificates for personnel engaged in drug inspection, maintenance, and other positions. Site Proof Materials: Property ownership certificates or lease agreements for the business premises and warehouse. Floor plans of the business premises and warehouse, indicating functional areas such as the pending inspection area, qualified area, and unqualified area, in compliance with the Good Supply Practice for Pharmaceutical Products (GSP). ...
- Source: drugdu
- 70
- May 8, 2026
PMEC China 2026

Organiser：Informa Markets Time：June 16 – June 18, 2026 Address：No. 2345 Longyang Road, Pudong New Area, Shanghai Exhibition hall：Shanghai New International Expo Center Product range: Pharmaceutical machinery, packaging equipment, intelligent manufacturing, pharmaceutical packaging materials, drug delivery devices and accessories, laboratory instruments and equipment, clean equipment and engineering, environmental protection and energy-saving equipment, life science instruments, bioengineering, pharmaceutical logistics equipment and services, equipment accessories About PMEC China： The World Pharmaceutical Machinery, Packaging Equipment and Materials China Expo (PMEC China) serves as a vital platform for product trade and information exchange in the global pharmaceutical industry. PMEC China has consistently been committed to showcasing the high-quality products and exceptional research and development capabilities of Chinese equipment manufacturing companies to the world. Meanwhile, numerous overseas buyers also regard PMEC as an important window for gaining insights into the Chinese market.
- Source: drugdu
- 81
- May 7, 2026
【EXPERT Q&A】What is the process for the production filing of Class I medical devices?

Drugdu.com expert’s response: The process for filing the production of Class I medical devices is as follows: 1. Corporate Qualification Preparation Legal Business License: The enterprise must possess a valid business license, with its business scope covering the production of medical devices. Production Conditions: Ensure that the enterprise has the necessary production conditions, including the configuration of hardware facilities such as factory premises, equipment, and personnel. 2. Product Classification Confirmation Class I Confirmation: Confirm that the product falls under the category of Class I medical devices by referring to the “Medical Device Classification Catalog” or consulting regulatory authorities for confirmation. Re-confirmation upon Changes: If there are changes in the product’s function or intended use, re-confirm its classification to avoid misclassification. 3. Filing Document Preparation Core Documents: Class I Medical Device Production Filing Form Product Technical Requirements Document: Clearly specifying performance indicators and testing methods. Production Quality Management Documents: Demonstrating the ...
- Source: drugdu
- 70
- May 6, 2026
IRAN HEALTH

Organiser：SANAT SALAMAT Newsad CO. Time：June 8 – June 11, 2026 Address：Tehran International Permanent Fairground, Chamran Expressway, Vali-e Asr Ave., Tehran, Iran Exhibition hall：Tehran International Exhibition Center Product range: Hospital equipment and medical devices, surgical instruments and medical-related books, X-ray, CT, MRI, nuclear medicine, imaging technology, pharmaceutical and herbal products, home medical equipment, physiotherapy, pharmaceutical raw materials, anesthesiology, respiratory instruments and equipment, pharmaceutical and packaging equipment, surgical techniques and equipment, healthcare products, sterilization and disinfection equipment, clinical chemistry automation devices, emergency medical equipment and pharmaceuticals, biotechnology laboratory equipment, surgical instruments and endoscopic equipment, blood bank equipment and refrigeration equipment, general and specialized diagnostics, dental care and treatment equipment, orthopedic technology and rehabilitation devices, oral care, consumables, and equipment (disinfection and technology) About IRAN HEALTH： The Iran Health Exhibition & Iran Dental Exhibition (IRAN HEALTH) is the most renowned and largest medical and pharmaceutical themed exhibition in Iran. Each year, ...
- Source: drugdu
- 84
- May 5, 2026
【EXPERT Q&A】Under the EU MDR regulation, what rules are used to determine the classification of medical devices?

Drugdu.com expert’s response: Under the EU Medical Device Regulation (Regulation (EU) 2017/745), the classification of medical devices is primarily based on their intended use and inherent risks, following a detailed set of classification rules that categorize medical devices into four classes: Class I, Class IIa, Class IIb, and Class III. Below are the core principles and logic of this classification system: I. Core Principles of Classification Risk Stratification: The higher the risk level, the stricter the classification and regulatory requirements. Intended Use as the Primary Factor: Classification is based on the manufacturer’s declared intended use, without considering misuse or abuse scenarios. Highest Risk Applies When Multiple Rules Apply: If a single device is subject to multiple classification rules, it is classified according to the rule with the highest risk. Key Factors: Invasiveness, Duration of Use, Active/Non-Active, and Site of Action: Invasiveness: Non-invasive, through body orifices, surgical invasive, implantable. Duration of ...
- Source: drugdu
- 82
- May 4, 2026
【EXPERT Q&A】What is the basic process for applying for a Class II medical device registration certificate?

Drugdu.com expert’s response: The basic process for applying for a Class II medical device registration certificate is as follows: 1. Product Classification Determination and Preliminary Preparations Confirm Product Classification: Verify that the product falls within the scope of Class II medical devices, either by referring to the “Medical Device Classification Catalog” or by applying to the provincial drug regulatory authority for classification determination (which takes approximately 20 working days). Complete Product Development: Conduct product research and development, trial production, testing, and evaluation. Develop production processes and documentation that meet regulatory requirements. Establish a Quality Management System: Ensure compliance with the “Good Manufacturing Practice (GMP) for Medical Device Production,” covering all aspects such as design and development, production, and inspection. 2. Product Inspection and Clinical Evaluation Full-Performance Inspection: Conduct type testing at a testing institution with CMA/CNAS accreditation (such as provincial medical device testing institutes). The testing cycle typically ranges from ...
- Source: drugdu
- 82
- May 1, 2026
CPhI China 2026

Organiser：Informa Markets Time：June 16 – June 18, 2026 Address：No. 2345 Longyang Road, Pudong New Area, Shanghai Exhibition hall：Shanghai New International Expo Center Product range: Core Raw Materials and Ingredients: Pharmaceutical raw materials, intermediates, fine chemicals, pharmaceutical excipients, veterinary drugs and feed additives, vitamins, amino acids and their derivatives, hormones, antibiotics, antipyretic and analgesic drugs, cardiovascular drugs, central nervous system drugs, respiratory drugs, digestive drugs, anti-parasitic drugs Natural Products and Extracts: Plant extracts, animal extracts, traditional Chinese medicine raw materials, health food raw materials, functional food raw materials, food and beverage raw materials, beauty and cosmetic raw materials Biotechnology and Pharmaceutical Services: Biological products and emerging therapies, peptide drugs, cell therapy, gene editing technology, biotechnology, bioengineering, life science instruments, pharmaceutical outsourcing services, contract customization Preparations and Finished Drugs: Preparations, veterinary drug preparations, respiratory drugs, anesthetic drugs, other western drug raw materials Pharmaceutical Machinery and Equipment: Pharmaceutical machinery and packaging equipment, ...
- Source: drugdu
- 149
- April 30, 2026
【EXPERT Q&A】What conditions are required to apply for a medical device registration certificate?

Drugdu.com expert’s response: The following conditions must be met for the application of a medical device registration certificate: I. Corporate Qualifications and Legitimacy The applicant must be a legally registered enterprise with a corresponding business scope and provide a valid business license. Enterprises involved in production activities are required to hold a Medical Device Production License (some categories may be exempted). For applications from overseas enterprises, it is necessary to provide medical device production qualification certificates and marketing authorization documents from their home countries (regions). II. Quality Management System The enterprise needs to establish a quality management system that complies with medical device production quality management regulations (such as ISO 13485). The system should cover the entire process, including product design, production, inspection, and sales, and be staffed with full-time quality management personnel. Provide quality management system documents, including procedural documents on management responsibilities, resource management, product realization, etc. III. ...
- Source: drugdu
- 85
- April 29, 2026
The world’s first biased GLP-1RA officially enters commercialization.

Today, the world’s first approved cAMP-biased GLP-1 receptor agonist, enoglutide injection (Xianweiying® ) , was simultaneously issued as the first batch of prescriptions nationwide at Peking University People’s Hospital and Zhongshan Hospital affiliated with Fudan University, marking the official entry of this innovative weight management therapy into the clinical application stage in China. Currently, there are two routes for the innovative development of GLP-1 receptor agonists. The traditional route uses GLP-1 as the core target, combined with other targets such as GIP and GCG. The biased signaling mechanism of enoglutin originates from the Nobel Prize-winning research on the structure and function of G protein-coupled receptors (GPCRs). The clinical use of enoglutin reflects a shift in weight management clinical practice from simply focusing on the rate of weight loss to a comprehensive consideration of tolerability, sustainability, and the overall patient experience. Addressing the Challenges of Long-Term Weight Management In recent years, ...
- Source: drugdu
- 94
- April 28, 2026
Breaking News! BeiGene Introduces a PD-1/VEGF Triple Antibody

On April 27, Huahui Anjian announced that it had entered into a global exclusive option, licensing and collaboration agreement with BeiGene for the novel tumor immunotherapy trispecific antibody HH160 , granting BeiGene an exclusive option involving the development, production and commercialization of the product. Under the agreement, BeiGene will pay Huahui Anjian an upfront payment of US$20 million. Huahui Anjian is entitled to an additional US$100 million exercise payment if BeiGene exercises its option. Upon achieving development and regulatory milestones, Huahui Anjian is entitled to payments of up to US$374 million. Upon achieving sales milestones, Huahui Anjian is entitled to payments of up to US$1.53 billion, and is also entitled to tiered licensing fees. In addition, both parties will actively negotiate and discuss BeiGene’s potential participation in Huahui Anjian’s financing, and the specific transaction terms and details will be determined through further negotiation. HH160 is a novel trispecific antibody developed ...
- Source: drugdu
- 100
- April 28, 2026

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