Search Results for “medical device” – Page 4 – media

【EXPERT Q&A】How to apply for the management record of Class II medical devices?

Drugdu.com expert’s response: The application process for the Class II medical device operation registration mainly involves the following steps: Ⅰ. Prepare Registration Materials 1.Enterprise Qualification Documents: Copy of the enterprise’s business license, certifying its legal business qualifications. 2.Organization code certificate (if applicable), verifying the enterprise’s organization code. 3.dentity cards, educational background, or professional title certificates of the enterprise’s legal representative or person in charge, and quality managers, to verify the identity and qualifications of relevant personnel. 4.Quality Management Personnel and Professional Technical Personnel Information: Work resumes of quality management personnel. 5.A list of professional technical personnel, along with their identity cards, educational certificates, and professional title certificates, to demonstrate the enterprise’s quality management capabilities and professional technical proficiency. 6.Business Premises and Warehouse Information: Geographical location maps and floor plans of the enterprise’s business premises and warehouse addresses, as well as commercial property ownership certificates, red lease contracts, or site usage certificates, to prove ...
- Source: drugdu
- 105
- August 14, 2024
【EXPERT Q&A】Why should the medical device industry strengthen compliance management under the normalization of collection?

Drugdu.com expert’s response: The main reasons for medical device industry to strengthen compliance management under the normalization of centralized procurement can be summarized as follows: I. Policy Drives and Strengthened Regulation 1.Normalization of Centralized Procurement Policy: The normalization of centralized procurement in the pharmaceutical industry refers to the long-term, stable, and institutionalized practice of governments or relevant agencies to conduct bulk procurement of medical products and services such as drugs and medical devices. This model aims to reduce procurement costs, improve procurement efficiency, ensure the quality and supply of drugs and medical devices, thereby meeting the basic medical needs of the people. Under the centralized procurement policy, medical device companies need to pay more attention to compliance management. 2.Strengthened Regulatory Efforts: With the promotion of numerous national policies such as medical anti-corruption, centralized procurement, and joint procurement, medical reform has been fully integrated into the overall process of deepening reforms, and regulatory ...
- Source: drugdu
- 82
- August 5, 2024
【EXPERT Q&A】What are the FDA-approved Consensus Standards for medical devices?

Drugdu.com expert’s response: FDA-recognized consensus standards for medical devices are a set of standards recognized by the U.S. Food and Drug Administration (FDA). These standards are developed by standardization organizations such as ISO, IEC, ASTM, and others, aiming to ensure the safety, effectiveness, and quality of medical devices. These standards cover various aspects of medical devices, including design, manufacturing, testing, clinical evaluation, and risk management. Ⅰ.Source of Standards: Consensus standards are usually developed by professional standard organizations like the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), and American Society for Testing and Materials (ASTM). These organizations, with the participation of a wide range of industry experts and stakeholders, create internationally recognized technical requirements and guidelines. Ⅱ.FDA Recognition: The FDA reviews and recognizes these standards, considering them to meet the FDA’s regulatory requirements. Recognized standards are listed in the FDA’s “Recognized Standards” list. Manufacturers can refer to these standards ...
- Source: drugdu
- 106
- August 2, 2024
【EXPERT Q&A】How to build the quality management system of aseptic IVD for medical devices?

Drugdu.com expert’s response: The establishment of a quality management system (QMS) for sterile in vitro diagnostic (IVD) medical devices is a complex and systematic process aimed at ensuring product safety, effectiveness, and compliance with regulatory requirements. Below is a detailed, professional step-by-step approach, referencing the Medical Device Manufacturing Practice and relevant regulatory mandates: I. Define Quality Policy and Objectives 1.Establish Quality Policy: The enterprise shall articulate a quality policy that embodies its commitment to medical device quality and patient safety. 2.Set Quality Objectives: Based on the quality policy, set specific, measurable quality objectives, such as product conformity rates and customer satisfaction levels. II. Establish Organizational Structure and Responsibilities 1.Setup Management Organization: Create a management structure tailored to medical device production, clearly defining the responsibilities and authorities of each department. 2.Appoint Management Representative: The corporate leader should designate a management representative responsible for establishing, implementing, and maintaining the QMS. 3.Clarify Responsibilities and Authorities: ...
- Source: drugdu
- 78
- July 31, 2024
【EXPERT Q&A】What is the specific process of medical device product registration?

Drugdu.com expert’s response: The medical device product registration certificate is a necessary credential for legal marketing and sales of medical device products. Its application process involves multiple stages, aiming to ensure the safety, effectiveness, and compliance of the products. Below is a detailed breakdown of the specific process for obtaining a medical device product registration certificate, divided into six phases. I. Preparation Before applying for registration, applicants need to thoroughly understand relevant national regulations and policies, including the “Regulations on the Supervision and Administration of Medical Devices” and the “Measures for the Administration of Medical Device Registration,” to ensure product compliance. At the same time, prepare necessary application materials, which include but are not limited to: 1.Enterprise Qualification Certificates: such as business licenses, medical device production licenses, etc. 2.Product Technical Data: detailing technical specifications, performance parameters, production processes, quality standards, etc. 3.Product Instructions: comprehensively describing usage methods, precautions, warning information, ...
- Source: drugdu
- 94
- July 29, 2024
【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
- 115
- 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
- 120
- 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
- 116
- 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
- 85
- 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
- 101
- July 3, 2024

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