UK Medical Device Registration: Everything You Need to Know When it comes to introducing your medical device to the UK market, compliance with the Medicines and Healthcare Products Regulatory Agency (MHRA) is a must. The MHRA is responsible for ensuring that all medical devices in the UK meet the highest standards of safety and efficacy. In this guide, we’ll walk you through everything you need to know about the United kingdom Medical Device Registration process, from the initial c...
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Complete Guide to SFDA Classification in Medical Device & MDMA in Saudi Arabia Bringing a medical device to market in Saudi Arabia involves more than just innovation; it requires a clear understanding of the Saudi Food and Drug Authority (SFDA) regulations. In this blog, we will cover the SFDA classification system, the process of obtaining Medical Device Marketing Authorization (MDMA), ensuring compliance with Saudi Arabia medical device regulations and how the Medical Device Establis...
Beauty Beyond Borders: A Comprehensive Guide to Cosmetic Regulations in Saudi Arabia
A Guide to Cosmetic Regulations in Saudi Arabia In recent years, the beauty and cosmetics industry has witnessed exponential growth worldwide, breaking down geographical barriers and creating a global marketplace. One country that has embraced this transformative trend is Saudi Arabia, where the beauty industry has flourished, reflecting the changing cultural landscape. However, with growth comes the need for regulations to ensure consumer safety and product quality. Legal Framework for Cosmetic...
Saudi Authorized Representative
Saudi Authorized Representative for Medical Devices Medical device manufacturers aiming to enter the Saudi market must comply with the Saudi Food and Drug Authority (SFDA) regulations. For companies without a legal entity in the Kingdom of Saudi Arabia (KSA), appointing a Saudi Authorized Representative (Saudi AR) is a mandatory requirement. This post explores the responsibilities of a Saudi AR and the advantages of working with medical device regulatory consultants in Saudi Arabia. Why...
Unlocking Opportunities: Understanding Saudi Arabia Medical Device Approval
Saudi Arabia Medical Device Approval The Saudi Arabian Medical device registration and Saudi Arabia medical device approval is governed by the Saudi Food and Drug Authority, also known as the SFDA. The procedure for the introduction of a medical device in the Saudi Arabian market is called Medical Device Marketing Authorization (MDMA). SFDA has published a guidance document, MDS-REQ-001, on Requirements for Medical Device Marketing Authorization. This guidance provides detailed information on th...
January Newsletter 2025- Simplified Chinese
Stay Updated with the Latest Industry Insights We look forward to sharing the latest updates and insights in our Chinese January Newsletter 2025. Stay informed about the most recent advancements and regulatory changes in the medical device and cosmetics industries. What’s Inside the January Newsletter 2025? For more details, read our full newsletter here: January Newsletter 2025- Simplified Chinese...
January Newsletter 2025- Korean
Stay Updated with the Latest Industry Insights We look forward to sharing the latest updates and insights in our January Newsletter 2025. Stay informed about the most recent advancements and regulatory changes in the medical device and cosmetics industries. What’s Inside the January Newsletter 2025? For more details, read our full newsletter here: January Newsletter 2025 – Korean...
January Newsletter 2025- English
Stay Updated with the Latest Industry Insights We look forward to sharing the latest updates and insights in our January Newsletter 2025. Stay informed about the most recent advancements and regulatory changes in the medical device and cosmetics industries. What’s Inside the January Newsletter 2025? For more details, read our full newsletter here: January Newsletter 2025 Stay informed, stay compliant...
Responsibilities of UK Responsible Person (UKRP)
To place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person. The UK Responsible Person must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person. Obligations of UK Responsible Person (UKRP) 1. Declaration of Conformity and Technical Documentation Verif...
India Introduces Reclassification of 1178 Medical Devices
India has announced a significant update to its regulatory framework for medical devices, with the Central Drugs Standard Control Organization (CDSCO) reclassifying 1,178 medical devices into four distinct categories. This move, aimed at enhancing patient safety and aligning with global practices, has been welcomed by industry experts and stakeholders alike. Understanding the Reclassification of 1178 Medical Devices in India The recently released draft list under the Medical Device R...
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