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Medical Device Regulations India - Frequently Asked Questions (FAQs)

Frequently asked questions (FAQs) regarding medical device registration and regulations in India

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Navigating Regulatory Gray Areas: Borderline Devices in the EU MDR and IVDR Era

In the world of medical devices, categorization and classification are essential processes that determine how products are regulated and...

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Navigating the Complex World of Combination Products: Understanding EU MDR Article 117

In the world of healthcare, many patients benefit from the use of combination products – medical devices that incorporate pharmaceuticals...

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The European Union Medical Device Regulation (EU MDR) represents a significant overhaul of the regulatory framework for medical devices...

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Navigating the EU MDR Labelling Requirements: A Comprehensive Guide

The European Union Medical Device Regulation (EU MDR) has ushered in a new era of regulatory compliance for medical device manufacturers....

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Regulation of Reusable Medical Devices under EU MDR

The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations...

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Understanding the CE Marking Process for Medical Devices in the EU

The CE (Conformité Européenne) mark is a critical certification for medical devices seeking approval within the European Union. It...

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Demystifying the Role of Indian Authorized Agents in Medical Device Registration

In the intricate landscape of medical device regulations in India, the role of the Indian Authorized Agent (IAA) stands as a pivotal link...

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UK Responsible Person (UKRP): Obligations for Medical Device Manufacturers Outside the UK

For medical device manufacturers located outside the United Kingdom (UK) without local business offices, it is mandatory to designate a...

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Meeting EU Regulations: The Role of the European Authorized Representative (EAR)

When foreign medical device and IVD manufacturers seek to distribute their devices within the European Union (EU) Member States,...

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Medical Devices Regulations and Registration in Indonesia

Medical Devices Regulations and Registration in Indonesia Although the manufacturing sector for medical devices in Indonesia is...

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Medical Device Regulations and Registration Process in Thailand

Medical Device Regulations and Registration Process in Thailand The production of medical devices in Thailand was estimated around 4.9...

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