Expert Q&A – Page 5 – media

【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
- 183
- 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 ...
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- 171
- 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
- 298
- 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
- 249
- 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
- 200
- February 10, 2025
【EXPERT Q&A】What are the differences between generic drugs and original drugs?

Drugdu.com expert’s response: Detailed Comparison Between Generic Drugs and Originator Drugs I. Definition and Background Originator Drugs: These are innovative drugs that are originally researched and developed by companies that hold the patent rights for the medication. These new drugs typically undergo long-term safety evaluations and complete Phase I to III (and sometimes Phase IV) clinical trials, followed by continuous post-marketing monitoring of their efficacy. The research and development (R&D) of originator drugs are usually initiated by large, financially strong pharmaceutical companies, taking up to fifteen years from R&D to market launch, with costs reaching billions of dollars. Generic Drugs: These are drugs that are developed after the patent protection period (typically 20 years) of an originator drug expires, based on research into the main active ingredient of the originator drug. The R&D process for generic drugs is relatively straightforward, involving the replication of the main molecular structure of the ...
- Source: drugdu
- 237
- February 7, 2025
【EXPERT Q&A】What are the requirements of EU medical device CE audit for quality management system document control?

Drugdu.com expert’s response: The CE certification requirements for medical devices in the European Union (EU) are quite stringent in terms of quality management system (QMS) document control. Below is an overview of the specific requirements: I. Content and Requirements of QMS Documents Completeness: The QMS documents should include policies, procedures, guidelines, forms, records, etc., comprehensively covering all aspects of the quality management system. These documents need to detail and prove that the product complies with EU regulations and standards, including but not limited to product design descriptions, performance test reports, risk assessment reports, biocompatibility assessment reports, electromagnetic compatibility test reports, etc. Accuracy: The information in technical documents must be accurate and capable of truthfully reflecting the technical characteristics and safety performance of the product. Traceability: The QMS documents should ensure the traceability of product quality, including raw material sources, production processes, quality control, and other links. Continuous Improvement: The QMS ...
- Source: drugdu
- 191
- February 5, 2025
【EXPERT Q&A】Do IVD clinical trials need to include interference samples?

Drugdu.com expert’s response: The inclusion of interference samples is necessary in IVD (in vitro diagnostic) clinical trials. According to the requirements of the Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents, subjects enrolled should be considered for inclusion of samples that may interfere with the test. This requirement aims to ensure the accuracy and reliability of IVD reagents in clinical use by evaluating their performance under complex conditions through the inclusion of interference samples. In practical operations, the selection and preparation of interference samples need to follow certain methods. For example, samples near the upper and lower limits of the reference range and medical decision levels can be selected as test samples, with hemoglobin, rheumatoid factor, and other interferents added to clinical samples. The volume of added interferents should generally not exceed a certain proportion of the total sample volume to ensure the validity of the test. In addition, ...
- Source: drugdu
- 191
- February 3, 2025
【EXPERT Q&A】What certifications are required for pharmaceutical exports to Saudi Arabia?

Drugdu.com expert’s response: For the export of pharmaceuticals to Saudi Arabia, the following certifications are mandatory: I. SFDA Certification Definition: SFDA certification refers to the certification of the Saudi Food and Drug Authority (SFDA). SFDA is responsible for regulating and managing the safety, quality, and effectiveness of products such as food, drugs, medical devices, and cosmetics to safeguard public health and safety. Importance: SFDA certification is essential for selling pharmaceutical products in the Saudi market. Products without SFDA certification cannot be legally sold. Only after obtaining SFDA certification can products be legally sold and used in the Saudi Arabian market. Application Process: Prepare product descriptions, technical specifications, manufacturing processes, quality management system documents, etc., for submission of the SFDA certification application. Select a qualified certification body (usually a third-party organization) to conduct product testing and evaluation, ensuring that the body has the appropriate experience and qualifications in SFDA certification. Submit ...
- Source: drugdu
- 212
- January 31, 2025
【EXPERT Q&A】Does European GPSR compliance require CE certification?

Drugdu.com expert’s response: Happy Chinese New Year! Detailed Analysis on the Relationship Between GPSR Compliance and CE Certification in Europe I. Concepts and Relationship Between GPSR and CE Certification GPSR (General Product Safety Regulation): It is a regulation of the European Union concerning the general safety of products, aiming to ensure that products placed on the EU market are safe under normal or reasonably foreseeable conditions of use. It covers a wide range of product categories, including toys, electrical appliances, and various consumer goods, requiring products to meet corresponding safety, health, and environmental standards. CE Certification: It constitutes the “essential requirements” of European directives and is considered as the “passport” for manufacturers to enter the European market. It indicates that the product complies with the basic requirements of the EU’s “New Approach to Technical Harmonization and Standardization” directives, involving mechanical safety, electromagnetic compatibility, low-voltage safety, and other aspects. Relationship: Partial ...
- Source: drugdu
- 222
- January 29, 2025

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