Expert Q&A – Page 4 – media

【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
- 89
- 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
- 113
- 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
- 95
- 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
- 75
- 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
- 83
- 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
- 79
- October 30, 2024
【EXPERT Q&A】Do I need a registered clinical trial for 3D endoscopy?

Drugdu.com expert’s response: Three-dimensional endoscopes typically require registration clinical trials, but the specifics of whether they are conducted and the requirements for clinical trials may vary based on product characteristics, registration region, and regulatory requirements. Ⅰ. Clinical Trial Requirements for Three-dimensional Endoscopes Regulatory Requirements: According to the relevant regulations of the National Medical Products Administration, medical devices generally need to provide clinical trial data during registration to prove their safety and effectiveness. As a type of medical device, three-dimensional endoscopes have certain complexity and risk in their design and use, thus usually requiring clinical trials to assess their performance. Product Characteristics: Three-dimensional endoscopes feature three-dimensional imaging capabilities, providing a more three-dimensional surgical view and aiding doctors in making more accurate judgments and operations. However, this new technology may also bring some unknown risks and side effects, which need to be discovered and assessed through clinical trials. Registration Region Differences: Different countries and regions may ...
- Source: drugdu
- 109
- October 28, 2024
【EXPERT Q&A】What is the role of the Drug Administration Act in ensuring the quality and safety of drugs?

Drugdu.com expert’s response: The “Pharmaceutical Administration Law of the People’s Republic of China” plays a crucial role in ensuring the quality and safety of drugs. Here are several key aspects of its role in this regard: Ⅰ. Defining and Classifying Drugs Article 2 of the Pharmaceutical Administration Law clearly stipulates that the drugs referred to in this Law are substances used for the prevention, treatment, and diagnosis of human diseases, for the purposeful regulation of human physiological functions, and with specified indications or functional indications, usage, and dosage, including traditional Chinese medicines, chemical drugs, and biological products. This definition clarifies the scope and classification of drugs, providing a legal foundation for subsequent regulatory work. Ⅱ. Establishing Strict Regulations for Drug Research and Development, Production, Operation, and Use Research and Development: Article 29 of the Pharmaceutical Administration Law stipulates that the research and development of new drugs must be conducted in accordance ...
- Source: drugdu
- 110
- October 25, 2024
【EXPERT Q&A】What is the process for registering apis in Saudi Arabia?

Drugdu.com expert’s response: Ⅰ. Preliminary Preparation and Research Before initiating the registration process, you need to: Conduct in-depth market research: Study the pharmaceutical market in Saudi Arabia to understand local demand for APIs, market size, and potential growth opportunities. Technical assessment: Evaluate whether your API product meets the quality and technical standards of Saudi Arabia. This includes assessments of production processes, quality control, stability, and other aspects. Regulatory familiarization: Thoroughly familiarize yourself with the registration requirements and processes of the Saudi Food and Drug Authority (SFDA) to ensure your product meets all relevant regulations. Ⅱ. Document Preparation and Submission Prepare registration documents: According to SFDA requirements, prepare complete registration documents, including product specifications, production process descriptions, quality control documents, stability study data, etc. Translation and notarization: If your documents are not in Arabic, they need to be translated into Arabic and notarized. Submit the application: Submit the registration application and ...
- Source: drugdu
- 115
- October 23, 2024
【EXPERT Q&A】What is the process for medical device export?

Drugdu.com expert’s response: The process of exporting medical devices involves multiple steps, as detailed below: Ⅰ. Market Research and Preparation Target Market Research: Conduct in-depth research on the medical device demand, regulations, standards, and competitors in the target market. Understand factors that may affect transactions, such as the target market’s political stability, trade policies, and currency exchange rate fluctuations. Product Registration and Certification: Complete product registration and certification according to the regulatory requirements of the target market. For example, the European market requires CE certification, and the US market requires FDA registration. Ensure that the products comply with the regulations and standards of the destination country to avoid trade barriers and compliance risks. Establishing a Sales Network: Establish contact with distributors, agents, or medical institutions in the target market. Participate in international exhibitions, seminars, and other events to communicate face-to-face with potential customers and showcase product advantages. Ⅱ. Production and ...
- Source: drugdu
- 113
- October 21, 2024

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