Expert Q&A – Page 13 – media

【EXPERT Q&A】What is OTC? What products do FDA need to apply for OTC?

Drugdu.com expert’s response: OTC stands for “Over-the-Counter,” referring to medications that can be purchased without a prescription from a healthcare professional. These medications are typically used to treat common health issues such as headaches, colds, fevers, and mild pains. In the United States, the Food and Drug Administration (FDA) regulates OTC drugs, and certain products require an application for OTC status before they can be sold on the market. Products that need to apply for OTC status according to the FDA include: 1.New Drugs: Drugs that have not been previously marketed require FDA approval before being sold as OTC products, regardless of their composition or effects. 2.Prescription Drugs: Some prescription drugs can apply for OTC status after undergoing clinical studies and safety assessments to demonstrate their safety and effectiveness. 3.Previously OTC Products with Safety Concerns: Certain OTC products may be required by the FDA to halt sales or undergo further ...
- Source: drugdu
- 275
- May 8, 2024
【EXPERT Q&A】What is CAPA for Medical Devices?

Drugdu.com expert’s response: Corrective and Preventive Actions (CAPA) in medical devices refer to a series of measures taken in response to identified issues or defects. CAPA aims to ensure the safety and effectiveness of medical devices and compliance with regulatory requirements. These measures include: 1.Corrective Actions: Steps taken to address existing issues or defects, aimed at eliminating or correcting their root causes to prevent recurrence. This may involve repairs, improvements to product design, or enhancements to manufacturing processes. 2.Preventive Actions: Measures taken to address potential issues or defects, intended to prevent future quality problems. This may include improving product design, updating manufacturing processes, or enhancing training. CAPA is an essential component of the quality management system for medical devices, often detailed in standards such as ISO 13485. Implementing CAPA helps ensure the safety, effectiveness, and quality of medical devices, while also ensuring compliance with regulatory requirements.
- Source: drugdu
- 251
- May 6, 2024
【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
- 246
- 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
- 187
- 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
- 162
- 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
- 144
- April 22, 2024
【EXPERT Q&A】What is the approval process of import and export declaration goods license?

Drugdu.com expert’s response: The approval process for import and export customs clearance permits typically involves the following steps: Application Preparation: Import and export companies prepare the necessary documents and information, including descriptions of goods, quantities, values, origins, destinations, as well as any required permits or certificates. Submission of Application: The application documents are submitted to the relevant import and export management department or agency. Applications can be submitted online or through traditional mail. Preliminary Review: The import and export management department conducts a preliminary review of the application documents to ensure completeness, accuracy, and compliance with relevant regulations and requirements. Approval: Following the preliminary review, further approval processes are carried out by the import and export management department. The specifics of the approval process depend on factors such as the type of goods, regulatory requirements in the country or region, etc. Issuance of Permit: If the application is approved, the ...
- Source: drugdu
- 263
- April 19, 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
- 184
- 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
- 132
- 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
- 177
- April 8, 2024

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