Expert Q&A – Page 10 – media

【EXPERT Q&A】How to handle the medical device network sales record certificate?

Drugdu.com expert’s response: To apply for the certificate of record-filing for online sales of medical devices, the following steps are typically involved: Preparation of Qualifications: Firstly, the medical device online sales enterprise needs to ensure compliance with relevant regulations and requirements, including business licenses, medical device operation permits, etc. Application for Record-filing: Submit the record-filing application to the relevant regulatory authority, which is usually the National Medical Products Administration (NMPA) or local drug regulatory department. The application needs to include basic information about the enterprise, information about the sales platform, types and quantities of medical devices sold, and other relevant information. Record-filing Review: The regulatory authority will review the record-filing application. The review process typically includes assessing whether the sales platform meets requirements and whether the medical devices sold comply with regulatory standards. Issuance of Certificate: If the record-filing application passes the review, the regulatory authority will issue the certificate ...
- Source: drugdu
- 140
- April 16, 2024
【EXPERT Q&A】What qualifications are required to sell a Class of medical devices?

Drugdu.com expert’s response: To sell Class I medical devices, you typically need to obtain the following qualifications: Medical Device Operation License: According to the “Regulations on the Supervision and Administration of Medical Devices,” any unit or individual engaged in activities such as production, operation, use, or technical services of medical devices must obtain a medical device operation license to operate medical devices. Business License: As a business entity, you need to have a valid business license to engage in legal business activities. Other Relevant Qualifications: Depending on the specific situation and requirements, you may also need to obtain other relevant qualifications such as medical device registration certificate, production license, etc.
- Source: drugdu
- 106
- April 11, 2024
【EXPERT Q&A】What is the basic process of Class II medical device registration certificate application?

Drugdu.com expert’s response: The basic process for applying for the registration certificate of Class II medical devices is as follows: 1.Document Preparation: Prepare all necessary documents for the application, including technical documentation for the product, clinical trial reports, quality management system documents, etc. 2.Application Submission: Submit the application documents to the National Medical Products Administration (NMPA) or relevant local drug regulatory authority. The application documents should include company information, product information, technical documentation, clinical trial reports, etc. 3.Preliminary Review: The drug regulatory authority conducts a preliminary review of the submitted application documents to ensure completeness and compliance with requirements. 4.Acceptance: After the preliminary review, the drug regulatory authority formally accepts the application and issues an acceptance notice. 5.Technical Review: Conduct a technical review of the application documents to assess the safety, efficacy, and quality control system of the product. 6.Clinical Evaluation: If necessary, conduct a clinical evaluation of the product ...
- Source: drugdu
- 149
- April 8, 2024
【EXPERT Q&A】What is the content of the MDR technical document that EU CE needs to submit for medical device registration?

Drugdu.com expert’s response: The MDR technical documentation required for medical device registration in the European Union typically includes the following components: 1.General Information: Basic product information, manufacturer details, product classification, and product description. 2.Design and Manufacturing Information: Details about the product’s design process, manufacturing process, material selection, assembly process, etc. 3.Performance and Functionality: Expected use of the product, performance indicators, technical specifications, functional descriptions, etc. 4.Risk Analysis: Analysis and assessment of potential risks associated with the product, including descriptions of control measures and risk management plans. 5.Clinical Evaluation: Clinical trial data and assessment results for the product, including trial design, results, safety, and efficacy data. 6.Summary of Technical Documentation: Comprehensive summary and explanation of the above content to ensure the integrity and consistency of the documentation. Additionally, depending on the specific characteristics and classification of the product, other relevant information and documents may be required to ensure compliance with the ...
- Source: drugdu
- 119
- March 30, 2024
【EXPERT Q&A】What is the QSR820 Quality System? What is the relationship with ISO13485?

Drugdu.com expert’s response: The US QSR820 quality system refers to the Quality System Regulation issued by the United States Food and Drug Administration (FDA) for medical devices. This regulation, also known as the Medical Device Quality System Standard, sets forth the quality management system requirements that medical device manufacturers must follow to ensure the safety and effectiveness of medical devices. QSR820 covers various aspects including design controls, production controls, equipment calibration, quality audits, record-keeping, etc. ISO13485 is the medical device quality management system standard published by the International Organization for Standardization (ISO). It bears some similarities to QSR820 as both are quality management system standards for the medical device industry aimed at ensuring product quality and safety. However, ISO13485 is an international standard applicable to medical device manufacturers globally, whereas QSR820 is a regulatory standard mandated by the FDA specifically for medical devices marketed in the United States.
- Source: drugdu
- 167
- March 27, 2024
【EXPERT Q&A】What is FDA Food grade certification?

Drugdu.com expert’s response: FDA food-grade certification typically refers to the certification or approval by the U.S. Food and Drug Administration (FDA) for food-related products. This certification generally includes two types: 1.Food Additive Approval: FDA’s certification of food additives involves the FDA approving a substance for use in food processing to improve the quality, freshness, taste, or other characteristics of food. These food additives may include preservatives, sweeteners, colorants, thickeners, etc. Once FDA approval is obtained, these additives can be legally used in food processing. 2.Food Contact Material Certification: FDA’s certification of food contact materials refers to the FDA approving a material for use in the manufacture or processing of food or potable water. These materials may include food packaging, containers, manufacturing equipment, etc., used to protect food from contamination or pollution. FDA-certified food contact materials typically comply with FDA regulations, ensuring that they do not pose a hazard to food ...
- Source: drugdu
- 130
- March 22, 2024
【EXPERT Q&A】What is temporary mining of medical consumables?

Drugdu.com expert’s response: “The procurement of medical consumables on an ad hoc basis” typically refers to the acquisition of medical consumables by healthcare institutions for clinical use, such as surgical instruments, dressings, syringes, catheters, and so forth. These consumables are essential for the daily provision of medical services in healthcare facilities. However, due to specific patient needs, types of procedures, and other factors, healthcare institutions may procure these consumables as needed during clinical practice rather than purchasing them in bulk beforehand. The term “ad hoc procurement” or “clinical procurement” implies that healthcare institutions purchase the necessary medical consumables based on current clinical demands and patient conditions. This ensures the smooth delivery of medical services. Unlike pre-planned routine procurement, clinical procurement is more flexible, allowing adjustments to be made promptly to meet specific medical needs as they arise.
- Source: drugdu
- 173
- March 20, 2024
【EXPERT Q&A】How to handle the Class II medical device management record, what materials need to handle?

Drugdu.com expert’s response: To apply for the record-filing of the distribution of Class II medical devices, the following materials are usually required: 1.Copy of the enterprise’s business license; 2.Medical Device Distribution License; 3.Identification of the legal representative; 4.Product registration certificate or record-filing certificate; 5.Quality management system documentation for medical devices; 6.Labels and instructions for medical device products; 7.Qualification certificates for sales personnel; 8.Proof of relevant premises use; 9.Other relevant documents that may be required. The required materials may vary depending on specific local requirements and regulations. It is advisable to consult the local medical device regulatory authority for the latest application guidelines and the list of required materials before proceeding with the record-filing process.
- Source: drugdu
- 154
- March 15, 2024
【EXPERT Q&A】Is there a requirement for the registration address of the second type of medical device business filing?

Drugdu.com expert’s response: There are usually requirements for the registered address when applying for the record-filing of the distribution of Class II medical devices. The registered address is typically required to be a legally operated premises that complies with relevant regulations, ensuring that the storage, sales, and management of medical devices meet the standards. Specific requirements may include the area of the premises, environmental conditions, storage facilities, safety measures, etc.
- Source: drugdu
- 248
- March 12, 2024
【EXPERT Q&A】How is the quality inspection and quarantine carried out in the import and export industry?

Drugdu.com expert’s response: In the import and export industry, quality inspection and quarantine procedures are typically carried out by the relevant national authorities, and the process generally includes the following steps: Declaration: Importers or exporters are required to submit necessary declaration documents and information to the customs or inspection and quarantine authorities, including descriptions of goods, quantities, values, etc. This information is used for preliminary assessment and registration by customs or inspection and quarantine authorities. Inspection and Quarantine: Before goods enter or leave the port, customs or inspection and quarantine authorities conduct inspections and quarantine procedures. This involves examining the appearance, quality, quantity, packaging, etc., of the goods and conducting necessary testing, inspection, disinfection, etc. Certification Documents: Based on the inspection and quarantine results, customs or inspection and quarantine authorities issue corresponding certification documents, such as quarantine certificates, quality certificates, etc. These certification documents are usually required to be presented to ...
- Source: drugdu
- 206
- March 8, 2024

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