Expert Q&A – Page 9 – media

【EXPERT Q&A】How many classes are medical devices divided into?

Drugdu.com expert’s response: Medical devices are typically categorized into three classes as follows: Class I Medical Devices: These devices pose a low level of risk and can ensure their safety and effectiveness through routine management. They are generally the basic and relatively safe medical tools commonly used in daily medical practice. Class II Medical Devices: This class of devices carries a moderate level of risk and requires stricter management measures to ensure their safety and effectiveness. They may involve certain usage risks, necessitating specialized personnel for supervision and control. Class III Medical Devices: These devices pose a high level of risk and necessitate the implementation of exceptionally stringent control measures to guarantee their safety and effectiveness. They are predominantly used for sustaining patient life, with many requiring entry into the human body, thereby harboring heightened risks that necessitate more rigorous supervision and monitoring. The classification of medical devices into these ...
- Source: drugdu
- 151
- July 17, 2024
【EXPERT Q&A】What are the differences between the Class II Medical Device Registration and the Class III Medical Device License? What are the application processes for each?

Drugdu.com expert’s response: There are significant differences between the Class II medical device registration and the Class III license in various aspects, mainly embodied in the risk levels of medical devices covered, management requirements, and application procedures. Below are detailed distinctions and their respective application procedures: 1.Differences Risk Levels and Management Requirements Class II Medical Devices: Pose moderate risks and require strict control management to ensure their safety and effectiveness. The safety and efficacy of these devices must be regulated to prevent unnecessary risks to patients or users during use. Examples include X-ray machines, B-mode ultrasound scanners, microscopes, biochemical analyzers, etc. Class III Medical Devices: Represent the highest level of medical devices and are subject to the strictest control. These devices are often implanted into the human body or used to support or sustain life, and their failure can cause severe harm or even death to patients. Therefore, their safety ...
- Source: drugdu
- 146
- July 12, 2024
【EXPERT Q&A】Which reports in the medical device industry are worth paying attention to?

Drugdu.com expert’s response: In the medical device industry, there are numerous reports worthy of attention, typically issued by industry research institutions, consulting firms, or relevant government departments. These reports aim to provide comprehensive insights into the current state of the industry, market size, development trends, competitive landscape, and more. Below are some of the most noteworthy medical device industry reports: 1.Global and China Medical Device Market Research Reports Issued by: Reputable global consulting firms such as McKinsey, Boston Consulting Group , Deloitte, among others. Content Overview: These reports comprehensively cover the overall size, growth rates, market segments (including diagnostic equipment, therapeutic devices, consumables, etc.), key market drivers, regional market analyses, competitive landscapes, and future trend forecasts for both the global and Chinese medical device markets. Value: Provide industry players with a holistic view of both global and Chinese markets, facilitating the formulation of internationalization and localization strategies. 2.Medical Device Technology ...
- Source: drugdu
- 151
- July 10, 2024
【EXPERT Q&A】Where can I download the approved online sales registration certificate for medical devices?

Drugdu.com expert’s response: After the approval of the online sales registration for medical devices, you can obtain and download the registration certificate through the following methods: 1.Online Platform or System: If you submitted the online sales registration application for medical devices through a specific online platform or system, there will usually be a corresponding function or option in the user interface of that platform or system for you to download the registration certificate. Log in to the online platform or system where you submitted the application and locate the relevant page or module for online sales registration of medical devices.On that page or module, you should be able to find the option to download the registration certificate. Click on the option and follow the system prompts to download it. 2.Government or Regulatory Agency Website: Visit the website of the government or regulatory agency in your country or region, as they ...
- Source: drugdu
- 99
- July 5, 2024
【EXPERT Q&A】How long does it take to register three types of medical devices in Russia?

Drugdu.com expert’s response: The registration process for Class III medical devices in Russia typically requires a period of 24 months or more. Based on official requirements and information from reference articles, here is a detailed explanation and summary of the registration timeline: Medical Device Classification: According to the Russian medical device classification standards, Class III medical devices fall into the high-risk category, requiring a more stringent registration and review process. Registration Process: The registration process includes appointing a Russian authorized representative, product classification identification, submitting technical documentation for medical devices, conducting system audits (if applicable), and undergoing RZN evaluation. Registration Timeline: Initial Review: Once the application materials are complete, the registration agency will submit the application to the Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor). The initial review may take several weeks to several months to confirm the completeness and compliance of the application documents. Detailed Review and Evaluation: ...
- Source: drugdu
- 118
- July 3, 2024
【EXPERT Q&A】Is it easy to apply for the EU CE certification?

Drugdu.com expert’s response: CE certification is a certification system established by the European Union to ensure the safety of products for people, animals, and objects. For companies that want to export their products to EU member states, CE certification is essential. From a process perspective, CE certification is not complicated, mainly including filling out an application form, providing product information, sending samples for testing, and obtaining a certificate or report after passing the test. The entire process is usually completed within 5-7 working days. Therefore, from an operational level, CE certification is relatively easy to apply for. However, it should be noted that the preparation of technical documents involved in CE certification is relatively cumbersome, including but not limited to the product name, model, instruction manual, safety design documents, technical conditions, electrical schematics, etc. Enterprises need to ensure that these documents are complete, accurate, and comply with relevant EU standards.
- Source: drugdu
- 144
- June 28, 2024
【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
- 164
- 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
- 176
- 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
- 180
- 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
- 213
- June 19, 2024

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