Drugdu.com expert’s response: The FDA registration review process for medical devices involves the following key steps: 1.Determine Product Classification: Firstly, the classification of the medical device needs to be determined, i.e., identifying which category it falls under in the FDA’s classification system. FDA categorizes medical devices into three classes: Class I, Class II, and Class III. The registration review process and requirements may vary depending on the device’s classification. 2.Prepare Registration Application: Prepare a comprehensive registration application package according to FDA requirements, including product description, technical specifications, design files, clinical trial data (if applicable), quality management system documentation, manufacturing process documentation, etc. 3.Submit Registration Application: Submit the complete registration application package to the FDA. Typically, this is done through the FDA’s electronic registration system, the FDA Unified Registration and Listing System (FURLS). 4.Registration Review: The FDA reviews the submitted registration application. During the review process, the FDA may request further information ...
Drugdu.com expert’s response: The declaration of Class I medical devices as non-medical or medical depends on the specific use of the device and the regulations of the target market. Typically, Class I medical devices refer to low-risk medical equipment, such as surgical instruments and some diagnostic devices. In most cases, these devices are categorized as medical because they are used directly or indirectly for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases. However, if the same type of device is intended for non-medical purposes (for example, solely for cosmetic or personal care), it may be classified as non-medical. In such cases, the classification should be determined based on the actual use of the device and the regulations of the target market. Therefore, when declaring, you should consider the following factors: Purpose of the Device: Is the main use of the medical device for medical or non-medical purposes (such ...
Drugdu.com expert’s response: The specific steps and requirements for exporting medical devices to the UAE include: Product Compliance Assessment: Ensure that the medical device complies with the specific standards of the UAE, including safety, efficacy, and quality control. Obtain international certifications such as the CE mark or FDA approval. Registration with the UAE Ministry of Health: Submit an application for medical device registration to the UAE Ministry of Health. This includes submitting detailed documents such as product descriptions, safety and efficacy data, and technical files. Choosing an Authorized Agent: Select an authorized agent in the UAE responsible for handling registration, import, and distribution matters. Ensure that the agent has a legal operating license and a good market reputation. Labeling and Instructions for Use: The product labels and instructions for use should meet the language requirements of the UAE (usually in Arabic and English) and include necessary product information such as ...
The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, delivering increased capacity for the certification of the performance and safety of medical devices, for healthcare professionals and the public. LNE-GMED UK and Scarlet NB UK join the seven current UK Approved Bodies, increasing capacity for the certification of medical devices in the UK. LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD). This comes after two of the existing UK Approved Bodies had their scope expanded, with UL International UK now designated to assess and certify general medical devices (in addition to in-vitro devices), and TÜV SÜD now designated to assess and certify ...
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: Medical trade, encompassing international exchanges of goods and services in the healthcare sector, is a distinct kind of commerce. Like other commodities, the trade of medical services includes both imports and exports. The essence of medical service trade lies in the local export of goods and services, characterized by its comprehensive and integrative nature. a. Local Export of Goods In countries or regions providing medical facilities, expenses incurred by international patients and their families for medical care, food, accommodation, transportation, tourism, shopping, and entertainment are paid in foreign currency. This method of generating foreign exchange revenue essentially represents a form of local export trade, realized through the provision of medical services on-site. b. Local Export of Services Apart from purchasing and consuming medical material products, patients and their families also utilize various service-related activities, as medical products inherently involve a significant proportion of service labor. For example, the ...
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 ...
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 ...
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 ...
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