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Medical Device Regulations India - Frequently Asked Questions (FAQs)
Frequently asked questions (FAQs) regarding medical device registration and regulations in India
Jan 17, 20245 min read
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...
Oct 1, 20233 min read
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...
Sep 29, 20235 min read
Deciphering Medical Device Risk Classification Under EU MDR
The European Union Medical Device Regulation (EU MDR) represents a significant overhaul of the regulatory framework for medical devices...
Sep 24, 20236 min read
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....
Sep 23, 20235 min read
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...
Sep 22, 20234 min read
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...
Sep 18, 20234 min read
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...
Sep 11, 20233 min read
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...
Sep 9, 20232 min read
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,...
Sep 6, 20234 min read
Medical Devices Regulations and Registration in Indonesia
Medical Devices Regulations and Registration in Indonesia Although the manufacturing sector for medical devices in Indonesia is...
Jul 21, 20237 min read
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...
Jul 20, 20238 min read
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