Drugdu.com expert’s response: Given your company’s plans to enter the Japanese market and previous export experience, we will skip the details on export qualifications. To market their products in Japan, medical device companies must comply with Japan’s Pharmaceutical and Medical Device Act (PMD Act). However, language barriers and complex certification processes pose challenges in the registration of medical devices in Japan. Under the PMD Act, the TOROKU registration system requires domestic manufacturers to register factory information with the government-authorized local authority, including product design, production, and key process information. Foreign manufacturers must register their manufacturing information with the PMDA (Pharmaceuticals and Medical Devices Agency). Process for PMDA Registration: 1.1 Preparation Stage. Determine the product classification (Class I, Special Control Class II, Class II, Class III, Class IV) and product JMDN code, select a Japanese Marketing Authorization Holder (MAH). 1.2 The manufacturer registers the factory with PMDA. 1.3 Class II Special Control ...
Drugdu.com expert’s response: For the export of in vitro diagnostic (IVD) medical devices to the European Union, certain types of products may require assessment or testing by designated European Union Reference Laboratories (EURLs). These reference laboratories mainly focus on high-risk in vitro diagnostic medical devices, particularly those closely related to public health. The types of IVD products typically evaluated by EURLs include: Infectious Disease Diagnostic Devices: For detecting major infectious diseases such as HIV, Hepatitis B, and Hepatitis C. Blood Screening Devices: Used for blood safety testing, such as devices for detecting pathogens in blood. High-Risk Cancer Biomarker Diagnostic Devices: For detecting high-risk biomarkers of certain types of cancer. Genetic Disease Diagnostic Devices: For detecting specific genetic diseases or susceptibilities. The EU designated reference laboratories include: ECDC (European Centre for Disease Prevention and Control): Responsible for the detection and control of infectious diseases. EURL for Blood Borne Infections: Specifically responsible ...
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 ...
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 ...
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 ...
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.
Niti Aayog is focusing on proposals to encourage domestic manufacturing of medical devices following orders from the Prime Minister's Office, said the expert. The meeting was focused on identifying the problems in local manufacturing and quality of the devices produced in India and also to spot the solution for the issues.
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