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General Information

Definition of a Medical Device around the global market

What is a Medical Device? The simplest definition of a medical device is a product used for treatment except for medicines. It is imperative to understand if the product classifies as a medical device and apply the regulations after defining it properly. An essential aspect of defining a medical device is its intended use. Intended use is the purpose of the device specified by the manufacturer. In this article, we have brought up the definition of “medical device” for a few major countries....
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Navigating Healthcare with Implant ID Cards: What You Need to Know?

Implant ID Cards Introduction Implanted medical devices, from life-saving pacemakers to pain-relieving joint replacements, are transforming how we manage health conditions. However, carrying these technological marvels within our bodies presents a unique challenge: readily accessing critical information about them when seeking medical care. This is where the power of implant ID cards comes into play. Think of these cards as miniature medical passports, discreetly holding a wealth of knowledge ab...
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OMC Medical to Showcase Global Market Access Solutions at KIMES 2024 

Book time with Gayathri Ganesan: KIMES Exhibition   OMC Medical Set to Attend KIMES, Invites Participants to Meet at UK Pavilion for Uninterrupted Market Access Solutions  SEOUL, SOUTH KOREA – February 21, 2024 – OMC Medical, a leading provider of regulatory support and market access solutions for medical device, cosmetics, and pharmaceutical manufacturers, announces its participation in the Korea International Medical & Hospital Equipment Show (KIMES) from March 1...
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Understanding the Key Responsibilities of an Authorized Representative in the Medical Device Industry

In the complex ecosystem of the medical device industry, ensuring compliance with regulatory standards and navigating the path to market access are crucial tasks. Amidst this complexity, one key player stands out: the Authorized Representative (AR). ARs are recognized globally under different titles, including Responsible Person (RP), Agent for Service of Process, Local Agent, Legal Representative (LR), and Designated Contact Point (DCP), Market Authorization Holder (MAH). Their role carries sig...
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Global Market Access Strategies for Software as a Medical Device (SaMD)

Introduction In the ever-evolving realm of healthcare technology, Software as a Medical Device (SaMD) stands out as a transformative force, offering personalized solutions tailored to individual patient needs. As demand surges for SaMD solutions worldwide, understanding and navigating international regulations are paramount for market access success. This article explores global strategies for achieving market access for SaMD, delving into the intricacies of international regulations and conform...
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Navigating Regulatory Requirements: Compliance Essentials for Post-Marketing Surveillance

The medical device industry thrives on innovation, but ensuring patient safety remains paramount. Regulatory compliance, particularly in post-marketing surveillance (PMS), is crucial for safeguarding patients and maintaining market access. This article explores the essentials of navigating regulatory requirements for medical devices, focusing on effective PMS practices. The Importance of Post-Marketing Surveillance Unlike pre-market testing, post-marketing surveillance monitors a device’s...
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License Transfer for Medical Device to new Local AR – New Zealand

Medical devices play a crucial role in healthcare by diagnosing, treating, and monitoring various medical conditions. These devices are designed and manufactured by companies that must obtain licenses to sell their products in different markets. When a company wants to transfer the license for a medical device to a new local Authorized Representative (AR) in a different country, such as New Zealand, there are several key steps and considerations that must be taken into account. Transferring the...
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License Transfer for Medical Device to New Sponsors from Existing License Holders

License transfer for medical devices is a crucial aspect of the regulatory landscape governing the manufacturing and distribution of medical products. It allows existing license holders to transfer the rights to manufacture and market a specific medical device to a new sponsor or entity. This process is essential for ensuring the continued availability and safety of medical devices in the market. License transfer allows for the continued availability of medical devices in the market, even as own...
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Bio Korea 2024 – The Future of Biotechnology Innovation and Global Collaboration

Every year, BIO KOREA organizes the International Convention with the goal of promoting and expanding the bio-health sector worldwide. We are happy to announce that the 19th BIO KOREA will take place at COEX in Seoul from May 8–10, 2024. This year too. Get the chance to network with international academics, professionals, and CEOs in the bio-health field, as well as exchange the latest trends and technologies in the field through BIO KOREA 2024’s Business Partnering, Invest Fair, Exhibit...
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The Role of Notified Bodies in Assessing Clinical Evaluation Reports (CERs) under EU MDR

Clinical evaluation is a continuous procedure that happens at every stage of a medical device’s life cycle. It is typically carried out initially in the course of developing a medical device to determine what data must be produced to gain access to the market. The first CE-marking must include a clinical evaluation, and it must be regularly updated going forward. Clinical evaluation is essential and significant because it guarantees that assessments of the device’s performance and sa...
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