Expert Q&A – Page 12 – media

【EXPERT Q&A】Simaglutide API is exported to Thailand, which registration qualifications need to be met and the registration process for drug registration in Thailand (preparation manufacturers are local enterprises in Thailand)

Drugdu.com expert’s response: 1.Registration Qualification Requirements ①Pharmaceutical Business License: To export Semaglutide API to Thailand, it is first necessary to ensure that your enterprise possesses a Pharmaceutical Business License, which is the basic qualification for drug export. ②GMP Certification: GMP certification refers to the certification of a pharmaceutical production quality management system. For the export of Semaglutide API to Thailand, your enterprise must also obtain GMP certification to ensure the quality and safety of the product. ③Pharmaceutical Quality Management System Certification: In addition to the above two qualifications, pharmaceutical quality management system certification is also necessary. This will help guarantee the quality of product sales and service in the Thai market. ④Pharmaceutical Liability Insurance: To safeguard the rights and interests of consumers, your enterprise should also consider purchasing pharmaceutical liability insurance. 2.Thai Drug Registration Process (Assuming the Formulation Manufacturer is a Local Enterprise in Thailand) ①Submission of Registration Application: ...
- Source: drugdu
- 193
- June 26, 2024
【EXPERT Q&A】What is the business process of exporting raw materials of Chinese companies to Indonesia to make medicines, health products and food raw materials?

Drugdu.com expert’s response: 1.Pre-preparation Stage ①Understanding Indonesian Market and Regulations: Firstly, Chinese companies need to understand Indonesia’s import regulations, regulatory requirements, and market demand for pharmaceuticals, healthcare products, and food ingredients, ensuring that exported products comply with Indonesian standards and regulations. ②Signing Trade Contracts: After clarifying market demand and regulatory requirements, Chinese companies should sign trade contracts with Indonesian importers or buyers, clarifying product specifications, quantity, price, delivery method, and other terms. 2.Export Declaration Stage ①Preparing Export Documents: Chinese companies need to prepare necessary export documents, including commercial invoices, packing lists, certificates of origin, export licenses (if required), etc. These documents must accurately reflect information such as product names, quantities, specifications, prices, etc. ②Export Declaration: Chinese companies submit export declaration forms and related documents to customs authorities for export declaration procedures. Customs authorities will review the information and documents to ensure they are complete and valid, and verify the ...
- Source: drugdu
- 212
- June 24, 2024
【EXPERT Q&A】How does the law regulate the production and sale of medical devices?

Drugdu.com expert’s response: In the production and sales of medical devices, countries have strict laws and regulations to regulate them. Taking China as an example, the Measures for the Supervision and Administration of Medical Device Production are formulated to strengthen the supervision and administration of medical device production, standardize medical device production activities, and ensure the safety and effectiveness of medical devices. The measures clarify the laws, regulations, rules, mandatory standards and quality management specifications that should be observed in medical device production activities, and require medical device registrants and filers to be responsible for the safety and effectiveness of listed medical devices. At the same time, according to the different levels of medical device risks, China also implements classified management for medical device production, requiring enterprises engaged in different types of medical device production to obtain corresponding production licenses or make filings according to law. In addition, the country ...
- Source: drugdu
- 206
- June 21, 2024
【EXPERT Q&A】What is the application and reliability of flexible circuit boards in medical devices?

Drugdu.com expert’s response: Flexible circuit boards (FPC) are widely used in medical devices, especially in scenarios that require high precision, high reliability, and high stability. Due to their strong flexibility and adaptability, FPC can be designed and manufactured according to the shape and size of the product, making them ideal for applications such as electrocardiographs, medical probes, and medical imaging devices. In addition, FPC also has characteristics such as vibration resistance, impact resistance, and anti-aging, further improving its reliability in medical devices.
- Source: drugdu
- 251
- June 19, 2024
【EXPERT Q&A】What is a medical device traceability system?

Drugdu.com expert’s response: The medical device traceability system is a full-process traceability management platform system that connects all aspects of medical device production materials, processing, and consumers, making the entire chain visible and transparent. The system consists of raw material and processing plant traceability management, production traceability management system, logistics distribution scanning system, sales market medical device traceability system, and consumer query system. Its main functions include the collection and tracking of production raw material information, medical device life cycle management, pre-event prevention, in-process control, and post-event traceability. Through this system, enterprises can improve the quality of medical devices, facilitate tracking management, and also provide consumers with a channel for query and traceability.
- Source: drugdu
- 194
- June 18, 2024
【EXPERT Q&A】The requirement of an EU Representative for CE certification brings several benefits and impacts?

Drugdu.com expert’s response: The benefits and impacts of requiring an EU Representative for CE certification can be summarized as follows: Benefits : 1.Communication Bridge: An EU Representative serves as an intermediary between manufacturers and EU authorities, effectively communicating and handling technical, regulatory, and after-sales issues related to products. This bridging role significantly simplifies the communication process between manufacturers and EU authorities, improving the efficiency of problem-solving. 2.Compliance Assurance: Through an EU Representative, manufacturers can ensure their products meet EU regulatory requirements, mitigating the risk of compliance violations due to unfamiliarity with local regulations. The EU Representative’s familiarity and understanding of EU regulations can provide manufacturers with guidance and support in terms of compliance. 3.Clear Responsibility: In the event of product issues, EU authorities can directly contact the EU Representative to take prompt action, such as product recalls. This clear responsibility approach enhances the efficiency of problem resolution, reducing delays ...
- Source: drugdu
- 122
- June 14, 2024
【EXPERT Q&A】What is FDA certification, and why is it necessary?

Drugdu.com expert’s response: FDA certification refers to the process in which the Food and Drug Administration of the United States reviews a product and recognizes that the product meets its qualification requirements. This certification is based on rigorous scientific evaluation and regulatory review to ensure that the safety, effectiveness, and quality of the product meet standards. The importance and reasons of FDA certification： 1.Ensuring product safety: FDA certification requires products to meet strict safety and effectiveness standards to ensure that consumers are purchasing safe and reliable products that do not pose a risk to human health. 2.Promote public trust: FDA certification is an important recognition of product quality and safety by the public, which can improve consumer trust and recognition of products and increase market competitiveness. 3.Encourage enterprises to operate in compliance with regulations: By obtaining FDA certification, enterprises need to strictly comply with relevant regulations and quality standards, which ...
- Source: drugdu
- 207
- June 12, 2024
【EXPERT Q&A】How to apply for a medical device class III business license?

Drugdu.com expert’s response: To obtain a Class III Medical Device Operating License, you would need to follow a specific process and meet certain requirements. Here is a general outline of the steps in English: 1.Prepare Application Materials: Gather all necessary documents, including the “Application Form for Medical Device Operating License” (signed by the legal representative or stamped with the company seal), proof of identity, education, and appointment documents for the legal representative. Also, provide copies of the “Pre-Approval Notice for Enterprise Name” or “Business License” issued by the Administration for Industry and Commerce. Additionally, submit proof of property or lease agreements with the lessor’s property certificate, as well as layout plans of the business premises and warehouse. 2.Submit Application Materials: Submit the prepared application materials to the local Food and Drug Administration or Market Regulatory Department. 3.Review and Onsite Inspection: The local Food and Drug Administration or Market Regulatory Department ...
- Source: drugdu
- 193
- May 22, 2024
【EXPERT Q&A】What does the 4-digit number next to the CE mark on medical devices mean?

Drugdu.com expert’s response: The 4-digit number next to the CE mark on medical devices indicates the Notified Body identification number (or Module D number). These digits identify the Notified Body that has certified the device’s quality management system. It signifies the registration number of the certifying body, indicating that it has assessed the quality management system of the medical device and confirmed its compliance with the relevant European Union directive requirements. This number is crucial for tracking the validity of the certification and for regulatory purposes.
- Source: drugdu
- 207
- May 16, 2024
【EXPERT Q&A】What does FDACFR21 in the United States refer to?

Drugdu.com expert’s response: The U.S. FDACFR21 regulations refer to Title 21 of the Code of Federal Regulations (CFR), which encompasses regulations established under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This set of regulations, overseen by the U.S. Food and Drug Administration (FDA), governs various aspects of the production, distribution, labeling, advertising, and safety of food, drugs, medical devices, cosmetics, and other related products. CFR Title 21 includes provisions covering: 1.Drug Quality and Manufacturing Practices: Regulations concerning quality control, processes, equipment, raw materials, packaging, and other aspects of drug manufacturing. 2.Food Labeling and Ingredients: Requirements for information on food labels, ingredient lists, nutrition labeling, etc., ensuring consumers receive accurate information. 3.Medical Device Registration and Reporting: Mandates for medical device manufacturers to register and report, as well as comply with relevant quality management system requirements. 4.Cosmetic Safety and Labeling: Standards for cosmetic safety, ingredient restrictions, and labeling requirements to ...
- Source: drugdu
- 239
- May 13, 2024

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