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Testing Standard Requirements around the World

Medical device testing standard- an overview Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and regulations of a country. Moreover, it also sheds light on any product defects. This article discusses the testing requirements and the applicable standards. Medical device testing applies to all medical devices, in-vitro dia...
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Top 7 Guidance On Class I Medical Devices

The EU MDR 2017/745 imposes more stringent requirements for Class I devices. Under the new regulations, Manufacturers must righty classify a medical device and provide technical documentation following the device class. The risk class under MDD could change under MDR. In some cases, medical devices could be up classified from Class I medical devices to Class II a/b medical devices or Class III medical devices. Please read our article on the classification of medical devices to understa...
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“Professional use” Test Kit – Procedure for Registration in UK 

“Professional use” Test Kit – Procedure for Registration in UK  Novel Corona Virus Disease 2019 (COVID-19) is a different variety of disease that has never been seen in humans before, impacting being a pandemic, and affecting the world since the year 2020. One of the most difficult aspects of coronavirus is the ambiguity of not knowing who has been infected or whether it is safe to resume normal activities. Testing of high quality might assist provide assurance. However, no good thing in...
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UK Cosmetics Requirements and Registration Process

The UK has specific regulations governing the safety, labelling, and marketing of cosmetic products. Post-Brexit, the UK has its own regulatory framework separate from the EU. UK Cosmetics Requirements & Registration Process This is an overview of the requirements and the registration process for cosmetics in the UK. 1. Regulatory Authority The main regulatory body overseeing cosmetic products in the UK is the Office for Product Safety and Standards (OPSS), which operates under the Departmen...
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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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Global ISO Requirements

What is ISO? ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards. These standards are developed by different committees within the International Organization for Standardization. Having around 165 member states, with one representative from each, International Organization for Standardization is a global entity catering to the needs of industry requirements. Are ISO standards impor...
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UDI DI

UDI-DI On 5 May 2017, the EU published the new EU MDR 2017/745 and IVDR 2017/746 regulations in which they formally introduced the UDI system in the EU. The UDI comprises the following components The Basic UDI-DI is a technique introduced by the EU for linking medical devices to their regulatory documentation so that the model of the product can be uniquely identified throughout its entire lifecycle. The linked documentation may include the declaration of conformity, notified body certificates,...
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