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. ...
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 ...
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 ...
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 ...
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.
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.
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.
Mike Bolduc, global marketing manager at C&K, once stated that since the market growth in terms of wearable medical devices wholesale reached $4 billion in 2017, it is expected to increase by 35 percent by 2019.
The demand for novel medical technologies seems to grow continuously. Hence there has been an increasing number of start-ups in order to fill the gaps by providing innovative solutions to persisting health issues. In this article, we will have a brief look at five of the world’s most promising medical device start-ups.
China's medical device market is growing at a rate of 20% a year, with more than 15,000 medical device manufacturers and 40,000 medical device traders. Often specific regions in the country have centralized manufacturing with higher production schedule efficiency of medical device products.
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