Expert Q&A – Page 4 – media

【EXPERT Q&A】How to do registration test and clinical evaluation for IVD reagents with different sampling methods?

Drugdu.com expert’s response: For IVD reagents with different sampling methods, their registration inspection and clinical evaluation need to follow certain procedures and standards to ensure product safety and effectiveness. Below is a detailed breakdown of this process: I. Registration Inspection 1.Selection of Representative Specifications for Inspection: According to the Measures for the Registration of In Vitro Diagnostic Reagents, if a registration application includes different packaging specifications (such as different sampling methods), one representative specification can be selected for inspection. The selected specification should cover the key performance parameters of all sampling methods, such as the limit of detection (LoD) and precision. 2. Performance Verification Items: Key Parameter Verification: This includes accuracy, precision (repeatability/reproducibility), LoD, limit of quantitation (LoQ), linear range, matrix effect, cross-reactivity, etc. Sampling Method Specificity Verification: Testing should be conducted separately for different sampling methods (e.g., manual/automatic, different sampling volumes) to ensure consistency in results. Communication with Inspection Agencies: ...
- Source: drugdu
- 95
- March 24, 2025
【EXPERT Q&A】What is the evaluation basis of the second type of medical device clinical trial verification?

Drugdu.com expert’s response: The evaluation basis for the clinical trial inspection of Class II medical devices mainly includes the following aspects: I. Regulatory Level Regulations on the Supervision and Administration of Medical Devices: As the basic regulation for the supervision of medical devices, this regulation stipulates the principles and requirements for the management of medical device clinical trials, serving as a crucial basis for clinical trial inspections. Measures for the Registration and Filing of Medical Devices: It clarifies the procedures, requirements, and conditions for the registration and filing of medical devices, providing a basis for the registration-related matters involved in clinical trial inspections. Measures for the Registration and Filing of In Vitro Diagnostic Reagents: This regulation standardizes the registration and filing of in vitro diagnostic reagents and serves as an important basis for the clinical trial inspection of Class II medical devices that are in vitro diagnostic reagents. Quality Management ...
- Source: drugdu
- 82
- March 21, 2025
【EXPERT Q&A】Why Class II and Class III medical devices should be registered?

Drugdu.com expert’s response: The registration of Class II and Class III medical devices is primarily based on the following reasons: I. Legal and Regulatory Requirements The “Regulations on the Supervision and Administration of Medical Devices” clearly stipulate that Class II and Class III medical devices must undergo registration management, and medical devices that have not undergone registration are prohibited from being sold and used in the market. This is a fundamental principle for the standardized operation of the medical device industry, and enterprises must comply with it to ensure legal operations. II. Risk Level Management Medical devices are classified into three categories based on their risk levels, with Class II and Class III belonging to medium and high-risk levels, respectively. Class II medical devices, such as thermometers, sphygmomanometers, and electrocardiographs, may lead to misdiagnosis, mistreatment, or cause certain harm to patients if there are issues with their quality or safety. ...
- Source: drugdu
- 102
- March 19, 2025
【EXPERT Q&A】What are the special environmental and facility requirements for the self-testing laboratory of IVD products?

Drugdu.com expert’s response: The self-testing laboratories for IVD (In Vitro Diagnostic) products have a series of specific requirements in terms of environment and facilities, which aim to ensure the safety, accuracy, and compliance of the laboratories. Below is a detailed summary of these requirements: I. Environmental Requirements Cleanliness: The cleanliness of the laboratory must meet the ISO 14644-1 standard, typically ISO 7 or ISO 8 class, to reduce particulate and microbial contamination. This helps ensure the accuracy and reliability of experimental results. Temperature and Humidity Control: The temperature is generally controlled between 20-25°C, and humidity between 30%-60%. Stable temperature and humidity conditions contribute to the normal operation of experimental equipment and the stability of experimental results. Biosafety: Depending on the type of experiments, the laboratory must comply with BSL-1 or BSL-2 (Biosafety Level Laboratory) standards. This includes setting up biosafety cabinets, installing HEPA filters, and other measures to prevent contamination ...
- Source: drugdu
- 92
- March 17, 2025
【EXPERT Q&A】How does Ibrutinib work?

Drugdu.com expert’s response: Ibrutinib demonstrates remarkable therapeutic efficacy, particularly in the treatment of various hematological malignancies. Below is a detailed analysis of its therapeutic effects: I. Primary Effects and Functions Inhibition of Malignant B-Cell Proliferation and Survival: Ibrutinib, as an inhibitor of Bruton’s tyrosine kinase (BTK), effectively inhibits BTK enzymatic activity by forming a covalent bond with the cysteine residue at the BTK active site, thereby blocking growth and survival signals in tumor cells. Reduction in B-Cell Migration and Adhesion In Vitro: By inhibiting BTK-mediated signaling pathways, ibrutinib further weakens the ability of malignant B-cells to spread and invade within the body, aiding in controlling disease progression. Improvement in Patient Prognosis and Quality of Life: For patients who have failed one or more lines of prior therapy, ibrutinib offers a new treatment option and extends patient survival. Additionally, it significantly improves patient symptoms, such as lymphadenopathy and fatigue, thereby enhancing ...
- Source: drugdu
- 111
- March 14, 2025
【EXPERT Q&A】What is the MDSAP review process and content?

Drugdu.com expert’s response: The Medical Device Single Audit Program (MDSAP) audit process is a systematic and standardized procedure designed to ensure that medical device manufacturers’ quality management systems comply with the regulatory requirements of various countries/regions participating in the MDSAP. Below is a detailed introduction to the MDSAP audit process and its contents: I. Audit Process Preparation Stage Understanding MDSAP Requirements: Firstly, enterprises need to thoroughly understand the MDSAP requirements, including the regulations, standards, and specific requirements of each participating country & region involved. Internal Audit and Preparation: Enterprises must conduct an internal audit of their quality management system to ensure it has been established and maintained in compliance with MDSAP requirements. This includes preparing necessary documents and materials such as quality management manuals, procedure documents, and records. Selecting an Audit Organization: MDSAP certification requires audits to be conducted by third-party audit organizations accredited by the International Medical Device Regulators Forum (IMDRF). Enterprises ...
- Source: drugdu
- 125
- March 12, 2025
【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
- 101
- 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
- 99
- 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
- 164
- 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
- 110
- March 3, 2025

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