Expert Q&A – Page 26 – media

【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
- 625
- 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
- 523
- 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
- 604
- 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
- 551
- 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
- 411
- 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
- 374
- 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
- 621
- February 12, 2024
【EXPERT Q&A】What are the steps in the FDA’s drug approval process?

Drugdu.com expert’s response: The drug approval process by the FDA is quite standardized and rigorous. Here’s a detailed breakdown of the entire process: Preclinical Studies: This is the first step in the drug approval process, involving pharmacological and toxicological studies to assess the drug’s safety and efficacy. These studies are usually conducted in laboratories or animal models. Submission of an Investigational New Drug Application (IND): Once preclinical studies indicate that the drug might be safe, pharmaceutical companies submit an Investigational New Drug application (IND). The IND includes preclinical study data, manufacturing information, and clinical trial protocols. Clinical Trials: This is the core part of the drug approval process and mainly consists of three phases. Phase I primarily tests the drug’s safety and dosage in humans; Phase II focuses on the drug’s efficacy and side effects; Phase III further confirms efficacy, monitors side effects, and compares the drug with existing treatments. ...
- Source: drugdu
- 541
- February 8, 2024
【EXPERT Q&A】What are the classifications of pharmaceutical intermediates?

Drugdu.com expert’s response: Pharmaceutical intermediates are one or more chemical substances generated during the drug synthesis process, playing a crucial role in the production of the final Active Pharmaceutical Ingredient (API). The variety of pharmaceutical intermediates depends on the chemical structure and synthesis pathway of the target drug. Here are some common types of pharmaceutical intermediates: Benzene Ring Intermediates: Many drugs, especially anticancer and cardiovascular drugs, are based on the benzene ring structure. Heterocyclic Compounds: Such as pyridine, thiophene, imidazole, etc., commonly used in pharmaceutical manufacturing. Amino Acids and Peptides: They are the foundation of many bioactive molecules and drugs, like insulin. Carboxylic Acids and Their Derivatives: Often used in the synthesis of anti-inflammatory drugs and antibiotics. Esters and Ethers: Utilized in the synthesis of various drugs, including painkillers and sedatives. Sulfur Compounds and Thioethers: Play an important role in the synthesis of certain special drugs. Aldehydes and Ketones: Key intermediates ...
- Source: drugdu
- 397
- February 5, 2024
【EXPERT Q&A】What documents and certifications are needed, and what are the main processes for exporting pharmaceuticals to Canada?

Drugdu.com expert’s response: Exporting pharmaceuticals to Canada requires adherence to specific processes and regulations. Here are the key steps for exporting pharmaceuticals to Canada: Understanding Canadian Regulations: Before exporting, familiarize yourself with the pharmaceutical regulations and regulatory requirements of Canada. Health Canada is the regulatory authority responsible for formulating and enforcing policies on drug imports. Familiarity with these regulations is essential to ensure that the exported pharmaceuticals comply with Canadian standards. Registration and Approval: Pharmaceuticals must be registered and approved by Health Canada before export. Depending on the type of drug, different application forms and materials may be required. Specific requirements can be found on Health Canada’s official website: https://www.canada.ca/en/health-canada.html Quality Management in Drug Production: Ensure that exported pharmaceuticals meet Canadian Good Manufacturing Practices (GMP). Exporting companies should regularly conduct internal audits to ensure compliance with GMP standards. Product Labeling and Instructions: Pharmaceutical labels and instructions must be prepared according ...
- Source: drugdu
- 501
- February 1, 2024

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