Search Results for “medical device” – Page 8 – media

FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization

Today, the U.S. Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization. This update will facilitate broader adoption of VHP as a sterilization method for the medical device industry, is part of the agency’s multi-pronged approach to reducing the use of ethylene oxide (EtO) where possible and further supports the agency’s efforts to advance medical device supply chain resiliency. Effective sterilization processes are necessary for certain devices to be safe because sterilization inactivates or kills potentially harmful microorganisms. In addition to effectively inactivating or killing potentially harmful microorganisms, sterilization processes must ...
- Source: drugdu
- 137
- January 10, 2024
FDA drafts guidance outlining real-world evidence for medical device submissions

Dive Brief The Food and Drug Administration posted a draft guidance on Monday clarifying how it evaluates real-world data in its decisions to clear or approve medical devices. The draft is an update to a final guidance in 2017 and includes more detail on how the agency assesses the relevance and reliability of real-world data, study design elements and recommendations on documentation for FDA review. An omnibus spending bill passed at the end of 2022 required the FDA to issue a draft guidance on the use of real-world data in premarket submissions. Two years after the public health emergency ended, the law also requires the FDA to specify how many requests for clearance or approval it has received and how many of those applications were approved or denied when real-world evidence was submitted. Dive Insight The 21st Century Cures Act, signed into law in 2016, created a framework for the ...
- Source: drugdu
- 117
- December 21, 2023
【EXPERT Q&A】What are the regulations and requirements for exporting medical devices to the European Union?

Drugdu.com expert’s response: Entering the European Union market requires medical device products to adhere to a series of stringent regulations and quality standards. Firstly, products must obtain CE certification, a mark that signifies compliance with EU requirements for safety, health, and environmental protection. Before submitting an application, make sure that all relevant application forms are completed in detail, including key data such as product specifications and manufacturer information. Upon passing preliminary review, the product will be sent to an EU-designated third-party certification body for comprehensive and accurate testing and evaluation. This body will assess the product’s compliance with the EU Medical Device Directive (MDD) or Medical Device Regulation (MDR), depending on the case. After successfully completing the certification process, you will receive EU export product certification, an indispensable credential proving that your product can be legally sold in the EU market. It should be noted that due to the wide variety ...
- Source: drugdu
- 320
- September 5, 2023
European Union medical device regulations
【EXPERT Q&A】What is the procedure for registering medical devices for the Russian market?

Drugdu.com expert’s response: The registration process in Russia mainly consists of the following steps: Submission of Application: First, you need to submit a registration application to the Russian Ministry of Health. This typically includes detailed information about your product such as the name, type, specifications, manufacturer information, etc. Technical Documentation Review: The Russian Ministry of Health will review the technical documentation you have submitted. This might encompass details of your product design, production process, quality control systems, etc. Clinical Evaluation: You might be required to undergo a clinical evaluation to demonstrate the safety and efficacy of your product. This could involve clinical trials or submission of other forms of clinical data. Manufacturer Review: The Russian Ministry of Health might review the manufacturer to ensure compliance with Russian laws and regulations. Obtaining the Registration Certificate: If your product passes the above steps of the review, you will receive a registration certificate. ...
- Source: drugdu
- 336
- August 22, 2023
medical device Russia market
【EXPERT Q&A】What are the market access requirements for medical devices entering the Ecuadorian market?

Drugdu.com expert’s response: The following are the market access requirements for medical devices entering the Ecuadorian market: Registration requirements: All medical devices must be registered with the National Agency for Regulation, Control, and Health Surveillance of Ecuador (ARCSA). Registration requirements include product technical documents, manufacturing license, quality management system, labels, instructions, and samples. License requirements: All medical devices require a medical device license in Ecuador to be sold in the market. The license application requirements include a registration certificate, manufacturing license, product instructions, and other relevant documents. Customs requirements: All imports of medical devices must comply with Ecuador’s customs regulations, including providing product information, product pricing, and the identity of the importer. Labeling requirements: All medical devices must have information such as the product name, usage, manufacturing date, expiration date, and the name and address of the manufacturer marked on the packaging. Ecuador’s medical device classification rules are based on ...
- Source: drugdu
- 294
- May 31, 2023
EPA proposes new ethylene oxide rules for medical device sterilization

April 12, 2023 By Jim Hammerand Leave a Comment FacebookTwitterLinkedIn New ethylene oxide rules from the EPA would reduce EtO emissions from commercial sterilizers by 80%, the agency said. The EPA this week proposed new regulations for companies that sterilize medical devices with EtO, following up on last week’s proposal for new EtO rules on chemical plants that make or store the sterilant. EtO is the most common method of medical device sterilization, used for around half of the 40 billion devices sterilized each year in the U.S. For some devices, there’s no alternative to EtO because gamma ray and electron beam sterilization can only be used on certain materials. FAQ: What is electron beam sterilization? But health risks for sterilization plant workers and neighbors have the EPA, FDA, Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA) working together to reduce those risks without reducing sterilization capacity. “OSHA’s mission is to ...
- Source: drugdu
- 235
- April 19, 2023
Etkin Medical Devices Ltd. – First Aid Equipment Supplier

Ddu (Drugdu.com) introduces a First Aid Equipment Supplier on its platform, namely Etkin Medical Devices Ltd. which is a well known Turkish company which has gained fame for the production of high-quality surgical lights. The First Aid Equipment Supplier was established in the year 1996 as a medical device sales and service company. The chief philosophy of the company relies on good quality and loyal customer service from the time of its inception. It began manufacturing and selling the LED surgical lighting systems in 2012 and is now a well-known brand all over the globe. The Government of Turkey recognized it among the fastest 100 Turkish companies in 2013 demonstrating a growth rate of 109%. Presently it only exports LED surgical light products their international business product. It focuses on ICU and OT lights. On Ddu, it offers its ETC LED EM 80 ET Kayra Examination Light, ETC LED EM ...
- Source: drugdu
- 907
- September 20, 2018
Wearable Medical Device to Promote Maternal and Fetal Health in Late Pregnancy

Many pregnant women sleep on their backs during the late stages of pregnancy. This, a new study found, can increase the risk of stillbirths due to oxygen deprivation followed by improper breathing of the fetus. Though positional therapy is suggested by the physicians, there was no concrete prove up until now.
- Source: ScienceDaily
- 1,333
- September 4, 2018
pregnancy Researches wearables
Join Drugdu.com’s Online Medical Devices Exhibition to Discover Global Trading Opportunities

SHENZHEN, China, Sep. 03, 2018 /PRWeb/ - Drugdu.com (Ddu), the leading global pharmaceutical and medical device B2B online platform, is presenting an Online Medical Devices Exhibition from September to December on Ddu’s official website and mobile app.
- Source: PRWeb
- 1,878
- September 3, 2018
Company Insight Drugdu.com medical device products pharmaceutical company
Wearable Medical Devices, Your Constant Healthcare Companion

Wearable Medical devices took the world by storm and have altered our way of life forever. In 2016 the market for wearables reached an estimated $2 billion and experts predict that this number will skyrocket to $6 billion by 2023.
- Source: Ddu
- 1,260
- August 28, 2018
medtech mHealth Researches wearables

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