Search Results for “medical device” – Page 6 – media

【EXPERT Q&A】What is the relationship between FDA registration and 510K registration for medical devices and what is the difference?

Drugdu.com expert’s response: The relationship between FDA registration and 510(k) clearance for medical devices involves overlap but also key distinctions. Relationship: 1.FDA Registration: This encompasses the process of submitting product information to the U.S. Food and Drug Administration (FDA) and obtaining FDA approval. It includes various types of registrations, such as 510(k) clearance, Premarket Approval (PMA), among others. 2.510(k) Clearance: This is a specific certification process within FDA’s regulatory framework, typically applicable to certain medical devices for which there are similar existing products on the market. In the 510(k) clearance process, manufacturers need to demonstrate that their product is substantially equivalent to an existing marketed device and does not pose an unreasonable risk to the user. Differences: 1.FDA registration is a broader concept encompassing various registration pathways, of which 510(k) clearance is one. 2.Within FDA registration, if a medical device can demonstrate substantial equivalence to a predicate device and meets ...
- Source: drugdu
- 173
- April 30, 2024
【EXPERT Q&A】What is the specific process of ce certification for medical devices?

Drugdu.com expert’s response: The specific process of CE certification for medical devices typically includes the following steps: 1.Preparation of Application: Manufacturers first need to prepare comprehensive application materials, including technical documentation, product specifications, quality management system documents, etc. 2.Selection of Certification Body: Choose an appropriate certification body for CE certification, ensuring that it is accredited and recognized. 3.Evaluation and Testing: The certification body will conduct evaluation and testing of the product to ensure compliance with the relevant European Union Medical Device Directives. 4.Compilation of Technical Documentation: Manufacturers need to compile complete technical documentation, including product descriptions, design files, test reports, etc. 5.Conducting Audit: The certification body will audit the manufacturer’s technical documentation to ensure its completeness and compliance with requirements. 6.Issuance of Certificate: If the product passes the audit and meets the requirements, the certification body will issue a CE certification certificate, confirming that the product complies with relevant standards ...
- Source: drugdu
- 131
- April 29, 2024
【EXPERT Q&A】What is the medical device registration process?

Drugdu.com expert’s response: The process for medical device registration typically involves the following steps: 1.Document Preparation: Gather all necessary documents and information, including product technical data, manufacturing processes, and quality management system documents. Requirements may vary by country or region. 2.Application Form Completion: Fill out the medical device registration application form, providing basic product information, technical characteristics, and manufacturing details. 3.Technical Evaluation: Submit the product’s technical documentation for evaluation by relevant authorities, assessing safety, efficacy, and performance indicators. 4.Clinical Trials (if required): Some medical devices require clinical trials to validate their safety and effectiveness. Applicants must conduct trials as per regulations and submit trial reports. 5.Quality Management System Review: Submit quality management system documents for review. Upon successful audit, obtain quality management system certification. 6.Submission of Registration Application: Submit the completed application form and relevant documents to the competent authority or agency. 7.Review and Approval: The competent authority or agency ...
- Source: drugdu
- 137
- April 25, 2024
【EXPERT Q&A】How to apply for a Class III Medical Device Operation License?

Drugdu.com expert’s response: Here are the general steps for obtaining a Class III Medical Device Operation License: 1.Qualification Review: First, ensure that your enterprise meets the conditions specified in the “Measures for the Administration of Medical Device Operation Enterprise Licenses,” such as registered capital, premises, personnel, etc. 2.Prepare Application Materials: Prepare the required application materials, including the enterprise legal person business license, medical device operation enterprise filing certificate, medical device quality management system certification certificate, etc. 3.Submit Application: Submit the prepared application materials to the local provincial-level or above drug supervision and administration department or its authorized drug supervision and administration institution. 4.Acceptance Review: The relevant department will review the submitted application to verify the completeness and accuracy of the materials. 5.On-Site Inspection: In some cases, applicants may need to undergo on-site inspections to confirm that their operating premises meet the relevant requirements. 6.Approval Decision: The relevant department will make ...
- Source: drugdu
- 105
- April 22, 2024
【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
- 131
- 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
- 99
- 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
- 137
- April 8, 2024
FDA hits Renovo with warning letter over reprocessed medical devices

Dive Brief Renovo received a warning letter in October for supplying reprocessed medical devices without seeking 510(k) clearance from the Food and Drug Administration. The letter, which the FDA published Tuesday, accuses Renovo of providing reprocessed models other than the ones covered by its 510(k) clearances. Renovo failed to evaluate how cleaning and re-sterilization of the additional models could affect performance and reliability. FDA inspectors also identified problems with Renovo’s approach to air particulate sampling that prompted warnings about the failure to establish control procedures. Dive Insight Renovo cleans medical devices that have been used in procedures such as the ablation of soft tissue for reuse. Renovo has multiple 510(k) clearances that permit the company to supply reprocessed versions of devices such as Depuy Mitek Ablation Wands and Ethicon Bladeless Trocars. The problem, according to the FDA, is that Renovo has reprocessed models that are outside of the scope of ...
- Source: drugdu
- 129
- April 1, 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
- 108
- March 30, 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
- 139
- March 15, 2024

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