Expert Q&A – Page 13 – media

【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
- 352
- 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
- 331
- 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
- 351
- 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
- 372
- February 19, 2025
【EXPERT Q&A】Medical devices nationwide collection price, long-term, what impact will it have on the industry?

Drugdu.com expert’s response: The nationwide centralized procurement and price reduction of medical devices will have profound and multifaceted impacts on the industry in the long run. Below is a detailed analysis of these impacts: I. Promoting Market Competition and Optimizing Supply Chain Management Intensified Market Competition: The centralized procurement and price reduction policy significantly lowers the prices of medical devices through volume-for-price exchanges, making market competition fiercer. To maintain market share and profitability, enterprises must strengthen product research and development (R&D), innovation, and improve product quality and cost-effectiveness. Optimized Supply Chain Management: The centralized procurement policy urges enterprises to optimize their supply chain management, reducing inventory pressure, enhancing supply efficiency, and lowering the circulation costs of medical devices. This helps enterprises improve operational efficiency, reduce costs, and thereby strengthen their market competitiveness. II. Facilitating Industry Transformation and Upgrade, as well as Domestic Substitution Driving Industry Transformation and Upgrade: Facing the ...
- Source: drugdu
- 390
- February 17, 2025
【EXPERT Q&A】What regulatory requirements does the FDA have for medical device usability engineering?

Drugdu.com expert’s response: The U.S. Food and Drug Administration (FDA) has clear regulatory requirements for the usability engineering of medical devices, primarily outlined in the “21 CFR 820” (Design Controls) and related guidance documents issued by the FDA. Below is a detailed summary of the FDA’s regulatory requirements for medical device usability engineering: I. Design Control Requirements According to “21 CFR 820.30,” the FDA requires medical device manufacturers to take appropriate measures during the design and development process to ensure that products meet safety and effectiveness requirements. These measures include, but are not limited to: Consideration of User Needs: The design team must thoroughly consider the end-users of the device, including healthcare professionals, patients, and the operating environment, to ensure that the product meets their usage needs and expectations. Risk Management: Designs must assess and mitigate potential use error risks, which is closely related to ISO 14971 (Risk Management for ...
- Source: drugdu
- 487
- February 14, 2025
【EXPERT Q&A】Which method (protein or nucleic acid) is better for drug resistance monitoring?

Drugdu.com expert’s response: In the context of antimicrobial resistance (AMR) surveillance, the choice between protein-based and nucleic acid-based detection methods primarily depends on specific surveillance needs, target pathogens, experimental conditions, and cost considerations. Below is a detailed comparison of the two detection methods: I. Advantages of Nucleic Acid Detection High Sensitivity: Nucleic acid detection directly targets the genetic material of pathogens, thus exhibiting high sensitivity. For instance, in tuberculosis AMR surveillance, nucleic acid mass spectrometry can be designed and utilized to identify genetic polymorphisms, achieving highly sensitive detection. High Specificity: With specific primers and probes, nucleic acid detection can achieve specific detection of target pathogens, avoiding false positive results. Rapid Detection Speed: With technological advancements, the turnaround time for nucleic acid detection has shortened, enabling rapid diagnosis of pathogens. Broad Application Range: Nucleic acid detection is applicable not only to bacteria but also to viruses, fungi, and other pathogens for ...
- Source: drugdu
- 295
- February 12, 2025
How DeepSeek Helps You Succeed Efficiently

In recent years, the application of artificial intelligence has been transforming industries at an unprecedented pace. As a leading AI-powered Q&A assistant, DeepSeek has quickly become a trusted partner for professionals in global trade. Particularly in the complex field of pharmaceutical trade, DeepSeek provides a range of practical tools to help businesses accurately target markets, enhance efficiency, and mitigate risks. As a global leader in cross-border pharma trade, Drugdu.com has explored ways to integrate DeepSeek’s capabilities with industry needs, delivering more efficient solutions to its users. Here’s how DeepSeek can empower your pharma trade business: I. Accurate Market Insights: AI as Your Detective (1) Quickly Identify Customers and Markets: Wondering which Southeast Asian country has the highest demand for raw pharmaceutical ingredients? DeepSeek uses big data analysis to provide swift, accurate answers and even generates visual reports, saving you time compared to traditional customs data checks. (2) Monitor Competitors in Real-Time: With DeepSeek, ...
- Source: drugdu
- 485
- February 11, 2025
AI DeepSeek Drugdu Pharma Trade
How DeepSeek Helps You Succeed Efficiently

In recent years, the application of artificial intelligence has been transforming industries at an unprecedented pace. As a leading AI-powered Q&A assistant, DeepSeek has quickly become a trusted partner for professionals in global trade. Particularly in the complex field of pharmaceutical trade, DeepSeek provides a range of practical tools to help businesses accurately target markets, enhance efficiency, and mitigate risks. As a global leader in cross-border pharma trade, Drugdu.com has explored ways to integrate DeepSeek’s capabilities with industry needs, delivering more efficient solutions to its users. Here’s how DeepSeek can empower your pharma trade business: Accurate Market Insights: AI as Your Detective Quickly Identify Customers and Markets Wondering which Southeast Asian country has the highest demand for raw pharmaceutical ingredients? DeepSeek uses big data analysis to provide swift, accurate answers and even generates visual reports, saving you time compared to traditional customs data checks. Monitor Competitors in Real-Time With ...
- Source: drugdu
- 475
- February 10, 2025
AI DeepSeek Drugdu Pharma Trade
【EXPERT Q&A】Why aren’t prescription drugs so tightly regulated?

Drugdu.com expert’s response: The reasons for the relatively lax regulation of prescription drugs involve multiple aspects, mainly including the following points: Profit-driven: The demand for prescription drugs is large and the profits are substantial, which leads some pharmacies to take risks and illegally sell prescription drugs in pursuit of profits. In a market economy, the primary business objective of pharmacies is economic benefits, so they may overlook the strictness of prescription drug regulation. Inadequate supervision: In some regions, the supervision of pharmacies is insufficient, making it difficult to effectively curb violations. The limited availability of regulatory resources and the relatively lagging regulatory measures may create loopholes in the practical operation of prescription drug regulation. Lack of consumer awareness: Some consumers lack sufficient understanding of the definition and importance of prescription drugs, making them susceptible to诱导by pharmacies. This information asymmetry leaves consumers with inadequate judgment and vigilance when facing prescription drugs. ...
- Source: drugdu
- 413
- February 10, 2025

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