Expert Q&A – Page 2 – media

【EXPERT Q&A】Why should the products exported to the EU be CE certified?

Drugdu.com expert’s response: Products exported to the European Union (EU) require CE certification primarily for the following reasons: I. Compliance with EU Regulations CE certification is a product certification system implemented by the EU to protect the safety of humans, animals, and plants, serving as a passport for manufacturers to access and enter the European market. According to EU regulations, only products with CE certification can freely circulate in the EU market and be considered to meet the basic requirements of EU directives. Therefore, CE certification is a mandatory threshold for products seeking to enter the EU market. II. Ensuring Product Safety The core purpose of CE certification is to ensure that products comply with relevant safety standards, providing consumers with reliable and consistent protection. By obtaining CE certification, products must meet a series of safety requirements aimed at preventing potential risks of personal injury and property damage during use. ...
- Source: drugdu
- 63
- March 10, 2025
【EXPERT Q&A】What is the role of medical collection?

Drugdu.com expert’s response: Pharmaceutical data collection plays a broad and far-reaching role, encompassing the entire lifecycle of the pharmaceutical industry, from research and development to sales. Here are the specific roles of pharmaceutical data collection: Supporting Market Analysis: Pharmaceutical data collection aids companies in analyzing market prospects, understanding industry trends and competitive landscapes, and provides data support for strategic planning. By comparing competitors’ products, companies can identify their strengths and weaknesses, thereby formulating more effective market competition strategies. Assisting in Product R&D: In the pipeline and planning stages, pharmaceutical data collection relies on mature data resources to analyze potential drug candidates through multiple dimensions such as clinical needs, competitive landscape, and market capacity, providing a scientific basis for product R&D. The data collected can also be used to assess the R&D prospects and market potential of drugs, helping companies optimize the allocation of R&D resources. Ensuring Drug Quality and Safety: Pharmaceutical data collection ...
- Source: drugdu
- 54
- March 7, 2025
【EXPERT Q&A】What is the role of the drug traceability code?

Drugdu.com expert’s response: The role of drug traceability codes is mainly embodied in the following aspects: Ensuring medication safety: Drug traceability codes can record the full chain of information from production to sales of drugs. By scanning the drug traceability code, consumers can easily inquire about key information such as the drug’s manufacturer, production date, expiration date, and circulation path, thereby quickly locating the drug and ensuring that the purchased drug is legal and compliant, thus safeguarding medication safety. Efficient recall management: The drug traceability code system enables rapid tracing of drug flows. Once a drug quality issue is discovered, relevant departments can precisely locate the problematic drugs, promptly recall and dispose of them, and prevent the problematic drugs from continuing to circulate, further ensuring medication safety. Strengthening medical insurance supervision: When pharmacists dispense drugs, they scan the drug traceability code, and the drug data is synchronously uploaded to the ...
- Source: drugdu
- 75
- March 5, 2025
【EXPERT Q&A】What is CE certification?

Drugdu.com expert’s response: CE Certification: A Detailed Explanation of the European Community’s Product Compliance Certification System Definition and Purpose CE Certification, an abbreviation for “Conformité Européenne,” refers to the certification that a product conforms to the technical regulations of the European Union. The primary purpose of this certification is to ensure that products meet the EU’s requirements in terms of safety, health, environmental protection, and consumer protection, thereby qualifying them for sale and circulation in the EU market. Scope of Application and Requirements Scope of Application: CE Certification applies to a wide range of products, including but not limited to machinery and equipment, wireless products, medical devices, toys, building materials, and commercial equipment. However, for specific products such as food, cosmetics, and pharmaceuticals, additional certifications or licenses are required for sale in the EU market. Additional Conditions: For certain products, specific additional conditions must be met to obtain CE Certification. ...
- Source: drugdu
- 71
- March 3, 2025
Revolutionizing Medical B2B Trade with AI-Powered Intelligence

I. How AI is Transforming the Medical B2B Industry? In the global pharmaceutical and medical device B2B trade landscape, businesses face numerous challenges, including information opacity, complex regulatory compliance, difficulty in tracking market trends, and cross-border communication barriers. As a leading B2B platform dedicated to the pharmaceutical and medical device industry, Drugdu.com (www.drugdu.com) provides global suppliers and buyers with a trusted marketplace for efficient sourcing and trade. To further enhance industry efficiency and optimize trade decision-making, Drugdu.com has officially launched Drugdu AI—a cutting-edge AI solution tailored for the pharmaceutical B2B sector. Powered by DeepSeek’s advanced AI technology, Drugdu AI leverages Drugdu.com’s extensive industry resources and global data to enable precise access to sector-specific insights, market trends, and compliance guidelines while paving the way for AI-driven trade decision-making in the future. II. What is Drugdu AI? 1. Drugdu AI is an AI-driven intelligent Q&A system developed by Drugdu.com, designed to provide pharmaceutical ...
- Source: drugdu
- 110
- February 28, 2025
【EXPERT Q&A】What are the differences between the second class filing and the third class license of medical devices?

Drugdu.com expert’s response: The medical device Class II registration and Class III license differ significantly in various aspects, including risk level, management approach, handling authority, scope of application, approval process, and regulatory intensity. Below is a detailed elaboration on these differences in English: I. Risk Level Class II Medical Devices: Pose moderate risks and require strict control and management to ensure their safety and effectiveness. These devices are typically used for prevention, diagnosis, monitoring, treatment, or alleviation of diseases in human extracorporeal organs, tissues, or bodily fluids, employing various technological means that may pose moderate risks to the human body. Examples include thermometers, sphygmomanometers, electronic blood pressure and pulse meters, acupuncture needles, magnetic therapy devices, hearing aids, infusion pumps, and electrocardiographs. Class III Medical Devices: Pose high risks and require special measures for strict control and management to ensure their safety and effectiveness. These devices are commonly used for diagnosing, ...
- Source: drugdu
- 96
- February 28, 2025
【EXPERT Q&A】Is CE certification required for EU GPSR compliance? What are the conditions?

Drugdu.com expert’s response: The Relationship Between EU GPSR Compliance and CE Certification Mandatory Compliance with GPSR: GPSR (General Product Safety Regulation) is a regulation of the European Union aimed at ensuring that products sold on the market are safe and do not pose a harm to consumers. Compliance with GPSR regulations is mandatory for most products. Definition and Scope of CE Certification: CE certification is a product compliance mark indicating that a product meets the safety, health, and environmental protection requirements of the European Union. It primarily applies to certain specific categories of products, such as electronics and machinery. Relationship Between GPSR and CE Certification: GPSR compliance and CE certification are two different compliance systems, but they overlap in some aspects. The directives and standards upon which CE certification is based correspond to the safety requirements of GPSR, but their focuses and scopes of application differ. Not all products that need to ...
- Source: drugdu
- 85
- February 26, 2025
【EXPERT Q&A】What is the European Medical Device Naming System EMDN?

Drugdu.com expert’s response: The European Medical Device Nomenclature (EMDN) is a naming system established by the European Commission to support the operation of the European Database on Medical Devices (EUDAMED). Below is a detailed introduction to EMDN: I. Background and Purpose Background: In accordance with Article 26 of the Medical Devices Regulation (MDR) (2017/745) and Article 23 of the In Vitro Diagnostic Medical Devices Regulation (IVDR) (2017/746), the European Commission decided to establish the EMDN system. Purpose: EMDN aims to support the regulatory requirements of MDR and IVDR, including the preparation of device and technical documentation, sampling audits of technical documentation by notified bodies, post-market surveillance, vigilance, and post-market data analysis. It also provides patients with key descriptions of medical devices that have been marketed and registered in EUDAMED. II. Structure and Composition Structure: The alphanumeric structure of EMDN is based on a seven-level hierarchy, but typically, a simplified three-level ...
- Source: drugdu
- 100
- February 24, 2025
【EXPERT Q&A】ECMO system made in China has been certified by the European Union for medical devices. What are the characteristics of the system?

Drugdu.com expert’s response: The Chinese-made ECMO system has obtained EU Medical Device Certification, and the characteristics of this system are mainly embodied in the following aspects: I. Independent Research and Development and Technological Innovation This ECMO system is independently developed by Shenzhen Hanno Medical Technology Co., Ltd., a Chinese enterprise, marking a significant breakthrough for China in the field of high-end medical equipment. The system adopts advanced deep learning algorithms, enhancing cardiopulmonary support for patients through precise data analysis and real-time monitoring. II. Four Core Products Extracorporeal cardiopulmonary support auxiliary equipment: Provides critical support for patients with cardiopulmonary insufficiency. Disposable membrane oxygenator set: Ensures hygiene and safety during the oxygenation process. Disposable membrane oxygenator: Achieves efficient exchange of oxygen and carbon dioxide. Disposable centrifugal pump head: Provides stable and reliable power support. III. Wide Range of Applications This system is not only suitable for cardiopulmonary support within hospitals but can ...
- Source: drugdu
- 92
- February 21, 2025
【EXPERT Q&A】Why should drugs and medical devices have FDA and CE certification?

Drugdu.com expert’s response: The necessity of FDA (U.S. Food and Drug Administration) and CE (Conformité Européenne) certifications for pharmaceuticals and medical devices is primarily based on the following reasons: I. Importance of FDA Certification Ensuring Product Safety and Effectiveness: The FDA conducts rigorous reviews and testing processes for pharmaceuticals and medical devices to ensure their safety and effectiveness. This is a crucial step in protecting consumer health. Enhancing Public Trust: Products that have obtained FDA certification are generally regarded as symbols of quality and safety, which helps to enhance public trust in these products. Market Access Requirements: FDA certification is a necessary condition for selling pharmaceuticals and medical devices in the U.S. market. Products without certification cannot enter the U.S. market. Facilitating International Trade: Many countries and regions refer to FDA certification standards when importing pharmaceuticals and medical devices. Obtaining FDA certification helps products gain broader recognition in the international ...
- Source: drugdu
- 81
- February 19, 2025

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