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Regulations

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Global Labelling Requirements
30May 2025
EU, Blogs, FDA, General Information, Regulations, UK, USA admin

Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)? 1. A Label is the written, printed, or graphic information that goes on the packaging of the medical device. 2. Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document. 3. Labelling is the content that goes on the Label or IFUs. What are the minimum requirements for labeling? The ISO has published many standard...
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30May 2025
EU MDR, Regulations Cubicdesignz

EU MDR Unveiled: What You Need to Know About Medical Device Regulation in Europe

Introduction about Medical Device Regulation in Europe Introducing the Medical Device Regulation in Europe addresses several challenges. It aims to enhance medical device regulation in Europe to ensure a higher level of safety and effectiveness. The need for the MDR arises from various factors, including shortcomings identified in the previous regulatory framework (Medical Device Directives) and the evolving landscape of medical technologies. Rapid technological advancements in the field of medi...
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08May 2025
Regulations, Blogs, CDSCO, India, Trending Now admin

Medical Device Registration Process CDSCO

If you plan to sell medical devices in India—either as a local manufacturer or a foreign company—you must register your product with the Central Drugs Standard Control Organisation (CDSCO). CDSCO is India’s national regulatory authority responsible for ensuring the safety, quality, and performance of medical devices and drugs. In this guide, we explain the CDSCO registration process step by step, including recent updates in 2025, required documents, timelines, and key responsibilities for...
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Clinical Evaluation vs Clinical Study
10Apr 2025
Blogs, Regulations, Trending Now admin

Clinical Study vs. Clinical Evaluation: What’s the Difference in Medical Device Regulation? 

In the medical device industry, the terms clinical study and clinical evaluation are often used interchangeably—yet they serve very different purposes. Understanding the distinction between the two is crucial for manufacturers aiming to obtain and maintain regulatory approval in key markets like the EU and UK. This article breaks down the difference between clinical study and clinical evaluation, and explains when and why each is required.  What is a Clinical Evaluation? A clinical evalua...
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20Mar 2025
EU, FDA, Regulations, USA Cubicdesignz

Cybersecurity for Medical Devices – FDA and EU MDR Perspective

Cybersecurity for Medical Devices FDA –Food and Drug Administration The revolution in the digital sector has resulted in the Internet of Things (IoT), Software as a Medical Device (SaMD), Internet of Medical Things (IoMT) and other connected devices permeating the healthcare environment, both in hospital and home, has ended up with the possibility of cyberattacks and intrusions against the connected medical devices and the networks to which such a device is connected. Most Medical devices are...
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20Mar 2025
Regulations Cubicdesignz

Switzerland Medical Device Regulations

Switzerland Market Situation Switzerland Market Situation – Downside Switzerland- Medical Device Regulations Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturers Outside Swiss – Proxy to the foreign manufacturer – Responsible for product safety – Liable for product defects – contact person for Swiss authorities – can be a legal entity or a natural person – must have access to PRRC Roles of Swiss AR’s PRRC Liability of a Swiss AR Manufacturer Re...
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10Mar 2025
Regulations Cubicdesignz

UK Medical Device Regulation

UK Medical Device Regulations Role of MHRA UK Approved Bodies Authorised Representatives Importer & Distributor Registrations in Great Britain Registration Data • Copy of Declaration of Conformity• E-copy of technical documentation• Device Certificate as granted by the Notified Body• Quality Management Certificate• Database information Manufacturing details• Letter of Designation• Contact persons and list of importers• Database information Device Details• Database informati...
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10Mar 2025
EU, Regulations, Swiss, UK Cubicdesignz

SaMD Devices Classification

SaMD is software intended for one or more medical purposes that perform these without being part of a hardware medical device. Medical device software is meant to be used, alone or in combination, for a purpose specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device. You can read more on the SaMD Regulation here. To be qualified as medical device software, the product must first...
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10Mar 2025
Regulations Cubicdesignz

MHRA Guidance on Stand-alone Software Medical Devices

Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices. In the UK, medical devices are subject to UKCA marking. The UKCA marking is no exception to software medical devices. MHRA Guidance on Medical Devices Software Medical Devices or not Classifying software or a mobile app as a medical device can be challenging. If t...
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10Mar 2025
FDA, EU, EU MDR, Regulations, USA Cubicdesignz

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices. The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device. Software...
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