Expert Q&A – media

【EXPERT Q&A】Medical device risk estimation, risk assessment, risk rating, what is it, what is the difference?

Drugdu.com expert’s response: In the field of medical devices, risk estimation, risk assessment, and risk rating are crucial steps in risk management, each with its own clear definition and distinction. Ⅰ. Definitions 1. Risk Estimation （1）Definition: The process of assigning values to the probability of occurrence and severity of harm. （2）Content: This typically involves analyzing factors such as the design, manufacturing process, and usage environment of medical devices to identify potential risk points. The purpose of risk estimation is to identify potential risks and provide a foundation for subsequent risk assessment. 2. Risk Assessment （1）Definition: The process of comparing “estimated risks” with “given risk criteria” to determine the acceptability of risks. （2）Content: Risk assessment is a more in-depth and systematic process that involves detailed analysis of identified risks, including the likelihood, severity, and effectiveness of risk control measures. The purpose of risk assessment is to determine the priority of risks ...
- Source: drugdu
- 33
- December 2, 2024
【EXPERT Q&A】What is the difference between a handheld nebulizer and a humidifier for medical devices?

Drugdu.com expert’s response: The handheld nebulizer used in medical devices differs significantly from a humidifier in multiple aspects, as detailed below: Ⅰ. Primary Functions and Purposes Handheld nebulizer: Primarily used for treating respiratory diseases such as asthma and bronchitis. It atomizes medication into tiny particles, allowing patients to inhale them directly into the respiratory tract for therapeutic effect. This device typically requires use under medical guidance and in conjunction with specific medications or solutions. Humidifier: Primarily functions to increase the humidity of indoor air, reducing discomfort caused by dryness. It generally uses purified water or filtered water and does not involve the atomization of medication. Humidifiers are widely used in homes, offices, and other settings to improve the indoor environment. Ⅱ. Atomized Particle Size Handheld nebulizer: Produces very small atomized particles, usually around 0.4 to 1 micrometer in size. This particle size makes the medication easier for the human body ...
- Source: drugdu
- 47
- November 29, 2024
【EXPERT Q&A】How does the medical device industry develop new channels and new markets under the normalization of collective mining?

Drugdu.com expert’s response: In the context of normalized centralized procurement, the medical device industry faces a new market environment and competitive landscape. To explore new channels and markets, enterprises can proceed from the following aspects: Ⅰ. Optimize Resource Allocation to Enhance Product Competitiveness Focus on Innovative Research and Development: Medical device enterprises should increase investment in innovative research and development to launch products with differentiated competitive advantages, thereby avoiding the risks associated with centralized procurement of homogeneous products. Through innovation, enterprises can open up new market segments, meet the needs of specific patients, and thus obtain higher market shares and profit margins. Diversify Product Lines: Expand the industry chain and enhance risk resistance capabilities with a multi-product portfolio. Enterprises can achieve seamless integration of the industry chain by acquiring upstream and downstream related enterprises, thereby enhancing product competitiveness and creating a synergistic effect. Ⅱ. Leverage Centralized Procurement Platforms to Expand Sales ...
- Source: drugdu
- 55
- November 27, 2024
【EXPERT Q&A】What is the difference between CE certification and FDA certification?

Drugdu.com expert’s response: Here is a detailed comparison between CE certification and FDA certification in multiple aspects, translated into English: Ⅰ. Issuing Authority and Definition CE Certification: Issued by the European Union, CE certification represents the safety certification of products in the European Union. It signifies that the product complies with the health, safety, and environmental protection regulations within the European Economic Area (EEA), serving as a “passport” for products to enter the EU market. FDA Certification: Issued by the Food and Drug Administration (FDA) of the United States, FDA certification is the regulatory agency of the US government for products related to human health and safety, including food, drugs, cosmetics, and medical devices. FDA certification is internationally recognized as one of the highest levels of safety certification and is a necessary condition for enterprises to enter the US market and some other countries with their products. Ⅱ. Scope of ...
- Source: drugdu
- 54
- November 25, 2024
【EXPERT Q&A】How to check the drug registration standards? Where do you find it?

Drugdu.com expert’s response: The inquiry of drug registration standards typically involves multiple levels and channels. Here are some suggested methods and avenues for inquiry: Ⅰ. Methods of Inquiry Official Website Inquiry: (1) CDE (National Medical Products Administration’s Center for Drug Evaluation) Website: CDE is responsible for the evaluation of drug registration applications, and its website usually publishes information related to drug registration. Through sections such as “Information Disclosure” or “Application Directory Browsing” on the CDE website, you can inquire about the overall acceptance status of drug registration applications and the progress of evaluation and approval. Additionally, CDE provides specific inquiry services for the acceptance, evaluation, and approval progress of drug registration applications, and applicants can inquire through the “Applicant’s Window” section. (2) National Medical Products Administration Website: The National Medical Products Administration is the authoritative agency for drug registration approval, and its website also publishes information and policies related to ...
- Source: drugdu
- 61
- November 22, 2024
【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
- 58
- 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
- 61
- 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
- 70
- 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
- 77
- 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
- 68
- November 11, 2024

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