Expert Q&A – Page 11 – media

【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
- 132
- 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
- 175
- 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
- 162
- 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
- 258
- 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
- 212
- March 8, 2024
【EXPERT Q&A】How to distinguish a class, Class II, Class III medical devices?

Drugdu.com expert’s response: Medical devices are typically classified into different categories, including Class I, Class II, and Class III, based on their level of risk and intended use. Here is a general overview of how these categories are distinguished: Class I Medical Devices: Class I medical devices are generally considered to have low risk and may have little or no impact on the human body. They typically do not require specialized regulatory controls.These devices include simple, non-invasive devices such as thermometers, disposable gloves, non-invasive blood pressure monitors, etc. Class II Medical Devices: Class II medical devices pose higher risks compared to Class I devices and may have a moderate impact on the human body, requiring stricter regulatory controls.Examples of Class II devices include diagnostic equipment, infusion pumps, medical imaging devices, implantable medical devices, etc. Class III Medical Devices: Class III medical devices carry the highest level of risk and may cause ...
- Source: drugdu
- 192
- March 5, 2024
【EXPERT Q&A】How to apply for Biologics License Application (BLA)?

Drugdu.com expert’s response: The Biologics License Application (BLA) is a licensing application for biologic products, typically managed and approved by the United States Food and Drug Administration (FDA). BLA submission is required to obtain approval for the sale of biologic products in the U.S. market. The following are the key aspects to consider and the required documents for BLA submission: 1.Clinical Trial Data: Detailed clinical trial data must be provided in the BLA submission, including study design, trial results, safety, and efficacy data. These data should adhere to FDA’s requirements for clinical trial design and reporting. 2.Product Quality Control: Information on product quality control, including manufacturing processes, quality control methods, stability data, etc., needs to be provided. These data ensure that the manufacturing process and quality of the product comply with FDA requirements. 3.Nonclinical Data: Relevant nonclinical data, such as animal model studies, toxicology data, etc., should be provided to assess ...
- Source: drugdu
- 178
- February 29, 2024
【EXPERT Q&A】What is the FDA registration review process for medical devices?

Drugdu.com expert’s response: The FDA registration review process for medical devices involves the following key steps: 1.Determine Product Classification: Firstly, the classification of the medical device needs to be determined, i.e., identifying which category it falls under in the FDA’s classification system. FDA categorizes medical devices into three classes: Class I, Class II, and Class III. The registration review process and requirements may vary depending on the device’s classification. 2.Prepare Registration Application: Prepare a comprehensive registration application package according to FDA requirements, including product description, technical specifications, design files, clinical trial data (if applicable), quality management system documentation, manufacturing process documentation, etc. 3.Submit Registration Application: Submit the complete registration application package to the FDA. Typically, this is done through the FDA’s electronic registration system, the FDA Unified Registration and Listing System (FURLS). 4.Registration Review: The FDA reviews the submitted registration application. During the review process, the FDA may request further information ...
- Source: drugdu
- 184
- February 26, 2024
【EXPERT Q&A】When exporting Class I medical devices, should they be declared for non-medical or medical use?

Drugdu.com expert’s response: The declaration of Class I medical devices as non-medical or medical depends on the specific use of the device and the regulations of the target market. Typically, Class I medical devices refer to low-risk medical equipment, such as surgical instruments and some diagnostic devices. In most cases, these devices are categorized as medical because they are used directly or indirectly for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases. However, if the same type of device is intended for non-medical purposes (for example, solely for cosmetic or personal care), it may be classified as non-medical. In such cases, the classification should be determined based on the actual use of the device and the regulations of the target market. Therefore, when declaring, you should consider the following factors: Purpose of the Device: Is the main use of the medical device for medical or non-medical purposes (such ...
- Source: drugdu
- 177
- February 15, 2024
【EXPERT Q&A】What is the process for exporting medical devices to the UAE?

Drugdu.com expert’s response: The specific steps and requirements for exporting medical devices to the UAE include: Product Compliance Assessment: Ensure that the medical device complies with the specific standards of the UAE, including safety, efficacy, and quality control. Obtain international certifications such as the CE mark or FDA approval. Registration with the UAE Ministry of Health: Submit an application for medical device registration to the UAE Ministry of Health. This includes submitting detailed documents such as product descriptions, safety and efficacy data, and technical files. Choosing an Authorized Agent: Select an authorized agent in the UAE responsible for handling registration, import, and distribution matters. Ensure that the agent has a legal operating license and a good market reputation. Labeling and Instructions for Use: The product labels and instructions for use should meet the language requirements of the UAE (usually in Arabic and English) and include necessary product information such as ...
- Source: drugdu
- 251
- February 12, 2024

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