Expert Q&A – media

【EXPERT Q&A】How to determine the clinical evaluation path of medical devices?

Drugdu.com expert’s response: The clinical evaluation pathway for medical devices is a crucial process for assessing their safety and effectiveness, determining their suitability for market release and clinical use. Below are the general steps and considerations for determining the clinical evaluation pathway for medical devices: Ⅰ. General Steps Clarify Product Characteristics and Scope of Application: Understand the basic principles, structural composition, manufacturing materials, and intended use of the medical device. First, confirm the scope of application of the product to facilitate targeted clinical evaluation. Assess Clinical Risks and Existing Clinical Data: Analyze potential adverse events or risks associated with the product during use. Evaluate whether sufficient clinical data exist to support the safety and effectiveness of the product. Select Clinical Evaluation Pathway: Based on product characteristics, clinical risks, and existing clinical data, select the most suitable clinical evaluation pathway. Ⅱ. Considerations Inclusion in the “Catalogue of Medical Devices Exempt from ...
- Source: drugdu
- 27
- November 20, 2024
【EXPERT Q&A】What are the requirements for naming in vitro diagnostic reagents?

Drugdu.com expert’s response: The naming of in vitro diagnostic reagents must follow a series of clear requirements to ensure the standardization, accuracy, and ease of understanding of the names. These requirements mainly include the following points: Ⅰ. Naming Structure The product name of in vitro diagnostic reagents typically consists of three parts: Name of the Substance Being Tested: This is the target substance that the reagent detects, and the name should accurately reflect the characteristics of the substance being tested. Purpose: Describes the purpose of the reagent, such as “assay kit,” “quality control material,” etc. This part helps users understand the specific application of the reagent. Method or Principle: Explains the method or principle of the reagent’s detection, such as “magnetic bead-based chemiluminescent immunoassay,” “fluorescent PCR method,” “fluorescent in situ hybridization,” etc. This information is usually listed in parentheses to provide additional technical details. Ⅱ. Specific Naming Rules Quantitative vs. Qualitative ...
- Source: drugdu
- 34
- November 18, 2024
【EXPERT Q&A】What should I pay attention to when IVD uses overseas clinical trial data?

Drugdu.com expert’s response: When using overseas clinical trial data for IVD (In Vitro Diagnostic) products, attention should be paid to the following aspects: Ⅰ. Data Quality and Integrity Ensuring Data Accuracy: Utilize validated data collection tools and methods, such as Electronic Data Capture (EDC) systems. Implement a double-entry and verification mechanism to reduce human entry errors. Conduct regular data consistency checks and logical checks to identify and correct abnormal values and errors. Ensuring Data Integrity: Maintain detailed records and traceability from trial design to data collection, processing, and analysis. Ensure that all relevant data is collected completely without omissions. Ⅱ. Data Compliance Adhering to Relevant Regulations and Guidelines: Understand and comply with the regulations and guidelines for in vitro diagnostic reagents in the target market (e.g., the European Union, the United States, etc.). For instance, the IVDR (In Vitro Diagnostic Medical Devices Regulation) of the European Union has specific requirements for clinical trial data. Ethical Review: Ensure that ...
- Source: drugdu
- 47
- November 15, 2024
【EXPERT Q&A】What is the concept of GMP certification? What is the connection between GMP and FDA?

Drugdu.com expert’s response: Ⅰ. GMP Certification Concept GMP, an acronym for GOOD MANUFACTURING PRACTICE, signifies “Good Manufacturing Practices” in Chinese. The World Health Organization defines GMP as a regulation guiding the production and quality management of food, pharmaceuticals, and medical products. GMP is a mandatory standard applicable to industries such as pharmaceuticals and food, requiring enterprises to meet hygiene quality requirements in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control, in accordance with relevant national regulations. It forms a set of operable operational norms to help enterprises improve their hygiene environment and promptly identify and rectify issues in the production process. GMP mandates that pharmaceutical and food production enterprises possess good production equipment, reasonable production processes, comprehensive quality management, and rigorous testing systems to ensure that the final product quality (including food safety and hygiene) meets regulatory requirements. In the pharmaceutical production ...
- Source: drugdu
- 52
- November 13, 2024
【EXPERT Q&A】What is a Certificate of Free Sale of medical Devices?

Drugdu.com expert’s response: Medical Device Free Sale Certificate (FSC): Definitions, Roles, Differences from Registration Certificates, and Application Process Ⅰ. Definition A Medical Device Free Sale Certificate (FSC) is a document issued by the competent authority or certification body in the country or region where the medical device manufacturer or supplier is located. It serves as proof that a specific medical device is legally and freely sold in its country of origin or region, and complies with the corresponding regulations and standards. Ⅱ. Roles Proof of Compliance: This certificate demonstrates that the medical device has passed the review and approval of the regulatory agency in the country of origin or region, and complies with local regulations and standards. Support for International Trade: The Medical Device Free Sale Certificate is often used to support international trade in medical devices, especially when entering certain countries or regional markets, proving that the product meets ...
- Source: drugdu
- 47
- November 11, 2024
【EXPERT Q&A】IVD self-test products apply for EU CE, need to pay attention to what?

Drugdu.com expert’s response: When applying for the CE certification for IVD self-test products in the EU, attention should be paid to the following aspects: Ⅰ. Understanding the IVDR Regulatory Requirements Regulatory Content: IVD self-test products need to comply with the regulations of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746). Product Classification: According to the IVDR, IVD products are classified into four risk categories: A, B, C, and D. Self-test products, which typically involve patients performing their own tests, may fall into higher risk categories, requiring special attention to relevant audit requirements. Ⅱ. Preparing Technical Documentation Completeness: Technical documentation should include product instructions, technical specifications, validation reports, quality control manuals, etc., and should be organized and numbered according to the order specified in Appendix II of the IVDR. Accuracy: The content of the documentation should be accurate and reflect the true performance and safety of the product. ...
- Source: drugdu
- 56
- November 8, 2024
【EXPERT Q&A】What are medical device quality management system nonconformities?

Drugdu.com expert’s response: Non-conformities in the quality management system for medical devices refer to situations where an activity or its outcome in the quality management system activities related to medical device production, sales, and after-sales service fails to meet established requirements or standards. These requirements or standards typically originate from relevant regulations, standards, contracts, and internal quality management system documents of the enterprise. Non-conformities can manifest in various forms, including but not limited to non-conformities related to documents, products, processes, personnel, environments, records, and data. Specifically, non-conformities in the quality management system for medical devices may involve the following aspects: Document Non-conformity: Quality management system documents do not comply with applicable laws, regulations, standards, or contracts. For instance, there may be no documented corrective action control procedure established, no clear review of nonconformities (including customer complaints), no determination of the causes of nonconformities, no evaluation of measures needed to ensure ...
- Source: drugdu
- 58
- November 6, 2024
【EXPERT Q&A】What is the need for a home monitor?

Drugdu.com expert’s response: The necessity of home monitoring devices is mainly reflected in the following aspects: Ⅰ. Enhancing Monitoring Efficiency and Accuracy Home monitoring devices can accurately monitor vital signs, including ECG, blood pressure, blood oxygen levels, body temperature, respiration, and other key indicators. These devices utilize advanced technology to quickly provide reliable data, allowing users to have a clear understanding of their health status. Compared to traditional self-monitoring methods, home monitoring devices are more precise and efficient, aiding in the timely detection of potential health issues. Ⅱ. Meeting the Need for In-home Monitoring With the intensifying trend of population aging and the rising incidence of chronic diseases, an increasing number of elderly individuals require long-term health monitoring. The portability and ease of use of home monitoring devices make in-home monitoring feasible. Elderly individuals can monitor their health at any time in their homes, eliminating the need for frequent visits ...
- Source: drugdu
- 58
- November 4, 2024
【EXPERT Q&A】What are the general procedures for CE certification?

Drugdu.com expert’s response: The process for obtaining CE certification generally includes the following steps: Ⅰ. Preliminary Preparations Determine Product Category and Directive: Firstly, it is necessary to determine the product category and the applicable CE directive. Different categories of products may be subject to different directives and standards, such as the Low Voltage Directive (LVD), Machinery Directive (MD), Electromagnetic Compatibility Directive (EMC), etc. Prepare Technical Documentation: Based on the requirements of the applicable directive, prepare the necessary technical documentation. These documents should be detailed, accurate, and meet the requirements of the directive. Technical documentation typically includes product specifications, design drawings, user manuals, circuit diagrams, block diagrams and wiring diagrams, lists of key components or raw materials, etc. Ⅱ. Select Certification Body and Submit Application Select Certification Body: Choose a qualified and experienced certification body for CE certification assessment. The certification body will test and evaluate the technical documentation and samples ...
- Source: drugdu
- 63
- November 1, 2024
【EXPERT Q&A】What is the impact on the industry that IVD registration certificates can be bought and sold?

Drugdu.com expert’s response: The impact of the tradability of IVD (In Vitro Diagnostic) registration certificates on the industry is multifaceted, encompassing the following aspects: Ⅰ. Facilitating Industry Consolidation Rapid Acquisition of Product Lines: Companies can quickly acquire new product lines by purchasing registration certificates, without the need for research and development from scratch, significantly shortening the time to market. Accelerating the Expansion of Large Enterprises: Large enterprises may rapidly expand their market share by acquiring registration certificates from smaller enterprises, further consolidating their market position. Ⅱ. Enhancing Research and Development Efficiency Focusing on R&D and Registration: Research institutions can concentrate more on product research and development, as well as registration, without worrying about subsequent production and sales issues. Shortening Product Cycles: By selling registration certificates to manufacturing enterprises, research institutions can obtain returns faster, thereby allocating more funds and resources to new research and development projects, further shortening the time ...
- Source: drugdu
- 63
- October 30, 2024

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