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Medicinal Products for Human
30Sep 2024
Blogs, General Information admin Comments: 0

Labelling and Packaging of Medicinal Products for Human use following Agreement of the Windsor Framework

1. Overview This guidance aims to outline the labelling and packaging requirements for medicinal products intended for human use, following the agreement of the Windsor Framework. It should be used alongside the existing guidance for wholesale dealers and manufacturers. The Windsor Framework establishes long-term arrangements for the distribution of medicines in Northern Ireland. It ensures that medicines can be approved and licensed throughout the UK by the Medicines and Healthcare products Reg...
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General Information September 26, 2024 admin Comments: 0

Medical Device Classification in Australia

In Australia, medical devices are classified into four risk-based categories: Class I (low risk), Class IIa, Class IIb, and Class III (high risk). The Therapeutic Goods Administration (TGA) oversees classification and regulatory approval. Higher-risk devices require more stringent evaluation, ensuring safety and efficacy before entering the market. Download the below PDF to get more detailed information about Different Categories of Medical Devices in Australia....
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Windsor Framework
23Sep 2024
EU, General Information admin Comments: 0

What Manufacturers and Wholesalers Should Know About MHRA Compliance and the Windsor Framework?

This essential guidance is tailored for manufacturers and wholesale dealers authorized by the Medicines and Healthcare products Regulatory Agency (MHRA). It serves as a comprehensive resource for Qualified Persons (QPs), Responsible Persons (RPs), and Responsible Persons for Import (RPis) to effectively implement the Windsor Framework’s new arrangements for human medicines. Key Responsibilities for Marketing Authorization Holders (MAHs) Marketing Authorization Holders must communicate any chan...
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Human Medicines
20Sep 2024
General Information, UK admin Comments: 0

UK-Wide Licensing for Human Medicines

1. Overview  This guideline gives information on how the Windsor Framework will be implemented in the UK regarding the licensing of medications for human use.   The Medicines and Healthcare Products Regulatory Agency (MHRA) will license medications throughout the United Kingdom starting on January 1, 2025.   The Human Medicines Regulations 2012 legislation, as amended by the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024, and other pertinent...
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mpox
28Aug 2024
General Information admin Comments: 0

Mpox: Origin, Global Impact, Testing, and Solutions

Mpox, formerly known as monkeypox, is a viral zoonotic disease that has rapidly emerged as a global health concern. The mpox virus, a member of the Orthopoxvirus genus, was first identified in humans in the Democratic Republic of the Congo (DRC) in 1970. For decades, the disease was mostly confined to Central and West Africa, where it remained endemic. However, beginning in the spring of 2022, mpox began spreading to countries outside of Africa, regions that had rarely seen cases in the past. Si...
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Medical Devices in South Korea
26Jul 2024
General Information admin Comments: 0

Import License Process for Medical Devices in South Korea: A Detailed Overview 

To engage in the importation of medical devices in South Korea, it is crucial to understand the regulatory requirements and obtain the necessary licenses and certifications. This comprehensive guide outlines the essential steps to secure an import business license from the Minister of Food and Drug Safety and comply with all relevant regulations.  Anyone looking to import medical devices must first obtain an import business license from the Minister of Food and Drug Safety. This license is esse...
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Medical Devices in South Korea
25Jul 2024
General Information admin Comments: 0

Labelling Requirements for Medical Devices in South Korea 

General Labelling Instructions for Medical Devices in South Korea  1.The label shall be printed in the ink, imprint, or stamp that cannot be easily erased, using Korean language in typefaces that are easy to read, such as the East Asian Gothic typeface.  1.1. Letters on the label shall not overlap with one another and shall also be in a color that is distinct from the background color, such as black letters on a white background.  2. Where a label is affixed on the container...
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south korea
25Jul 2024
Registrations, General Information admin Comments: 0

Why South Korea is a Booming Market for Medical Devices? 

South Korea has emerged as a significant player in the global medical device market, and its growth trajectory is impressive. The convergence of government support, advanced technology, a strong domestic market, and strategic trade positions South Korea as a hub for medical device innovation and investment.  Here’s an in-depth exploration of the factors contributing to this booming market.  1.Government Support and Strategic Policies  1.1. Regulatory Framework and Incentives&nbs...
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12Jul 2024
General Information Cubicdesignz Comments: 0

Product Liability Insurance for Medical devices

Medical devices are subject to product defects. These product defects arise due to design, manufacturing or even a failed instruction for use of a product. These defects can cause risks to patients, who in turn can sue the manufacturer for the damages caused. As medical device manufacturers, it is imperative to choose insurance that best covers themselves as well as their affiliates. Product liability was brought in place to ensure that potentially unsafe products are discouraged from being plac...
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12Jul 2024
General Information Cubicdesignz Comments: 0

Establish a Medical Device Startup Company

Introduction: Medical device startups play an essential role in revolutionizing patient care and improving quality of life. If you share our passion for innovation, starting a medical device company could prove rewarding yet challenging – this article offers comprehensive guidance to help get one started. Tips to start a Medical Device Startup Company 1. Brainstorm an Engaging Idea: Every successful medical device startup begins with an original idea. Start by researching the healthcare in...
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