Search Results for “medical device” – Page 5 – media

【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
- 144
- 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
- 171
- 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
- 131
- June 18, 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
- 135
- 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
- 139
- May 16, 2024
MHRA’s AI Airlock to address challenges for regulating AI medical devices

The sandbox will help to inform future AI Airlock projects and influence future AlaMD guidance The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, a new regulatory sandbox, to address the challenges of regulating medical devices that use artificial intelligence (AI). In alignment with the regulator’s goal for the UK to be a science and technology superpower by 2030, the new sandbox builds on the MHRA’s strategic approach to AI in April, which was set out to respond to a white paper published by the government in 2023. It highlighted that the regulator is considering the opportunities and risks of AI from three perspectives: as a regulator of AI products, as a public service organisation delivering time-critical decisions and as an organisation that produces evidence-based decisions that impact public and patient safety, where evidence is often supplied by third parties. The new sandbox for AI as a ...
- Source: drugdu
- 116
- May 15, 2024
FDA posts final guidance on remanufacturing medical devices

Dive Brief The Food and Drug Administration published final guidance on the remanufacturing of medical devices on Thursday. Acting on feedback from groups including Advamed, the FDA has changed the title of the text and added a section on the regulatory requirements for remanufacturers. The new section, which applies to original equipment manufacturers and service providers, is intended to help entities that are less familiar with the medical device regulatory requirements. Dive Insight The FDA published draft guidance in 2021 to clarify the distinction between device remanufacturing and servicing. Many reusable medical devices are serviced. Previously, it was unclear when servicing became so extensive that it qualified as remanufacturing. The draft defined remanufacturing as an act done to a finished device that significantly changes the performance, safety or intended use, including renovating, repackaging or restoring products. After assessing feedback on the draft, the FDA has retained its definition of remanufacturing ...
- Source: drugdu
- 102
- May 13, 2024
【EXPERT Q&A】What is CAPA for Medical Devices?

Drugdu.com expert’s response: Corrective and Preventive Actions (CAPA) in medical devices refer to a series of measures taken in response to identified issues or defects. CAPA aims to ensure the safety and effectiveness of medical devices and compliance with regulatory requirements. These measures include: 1.Corrective Actions: Steps taken to address existing issues or defects, aimed at eliminating or correcting their root causes to prevent recurrence. This may involve repairs, improvements to product design, or enhancements to manufacturing processes. 2.Preventive Actions: Measures taken to address potential issues or defects, intended to prevent future quality problems. This may include improving product design, updating manufacturing processes, or enhancing training. CAPA is an essential component of the quality management system for medical devices, often detailed in standards such as ISO 13485. Implementing CAPA helps ensure the safety, effectiveness, and quality of medical devices, while also ensuring compliance with regulatory requirements.
- Source: drugdu
- 176
- May 6, 2024
Lupin Digital Health’s Lyfe Platform gets Class C Medical Device License from CDSCO

Lupin Digital Health’s Lyfe platform has received approval as a Class C Medical Device from the Central Drugs Standard Control Organisation (CDSCO). A press statement informed that Lyfe is now India’s first clinically proven remote cardiac rehabilitation program, designed to enhance heart health and quality of life. By providing tailored, accessible solutions in the comfort of patients’ homes, Lyfe empowers individuals to confidently manage their heart health. Rajeev Sibal, President – India Region Formulations, Lupin, stated, “This approval reaffirms our dedication to excellence in cardiac care. We are proud to be at the forefront of digital therapeutics in India, signifying our commitment to supporting cardiologists with patient-centric solutions and improving cardiovascular outcomes.” Elaborating on the significance of receiving this license, Sidharth Srinivasan, CEO, Lupin Digital Health added, “Securing the Class C Medical Device license for Lyfe is a significant achievement. It validates Lyfe as a best-in-class platform to support millions ...
- Source: drugdu
- 81
- May 5, 2024
UK sets out position on regulating AI as a medical device

Dive Brief A U.K. agency outlined its position on the regulation of artificial intelligence as a medical device in a policy paper published Tuesday.The Medicines and Healthcare products Regulatory Agency (MHRA) said many AI products that can be put on the market now without conformity assessment will move to a higher risk category in upcoming reforms.The paper explains how MHRA interprets a government AI strategy focused on principles such as safety, security and robustness and aligns it with international standards. Dive Insight The U.K. government committed to five cross-sector principles for the regulation of AI in February. A consultation found “strong support” for the principles, the government said, and established them as the basis for a regulatory framework designed to keep pace with rapidly advancing AI technology. Days later, the government wrote to the MHRA to request details of its approach to AI. In response, the MHRA published a policy ...
- Source: drugdu
- 111
- May 5, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.