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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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. ...
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 ...
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