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...
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Sep 23, 20235 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 22, 20234 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 21, 20237 min read
Understanding System and Procedure Packs in Accordance with EU MDR
In the realm of modern healthcare, the role of system and procedure packs cannot be overstated. These packs serve as invaluable tools,...
Sep 18, 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 17, 20238 min read
Regulation of Reprocessed Single-Use Devices (SUD) under EU MDR
"Reprocessing" denotes a series of procedures conducted on a previously used device to enable its safe reuse. This encompasses cleaning,...
Sep 16, 20235 min read
Reprocessing Single-Use Devices in accordance with EU Medical Device Regulations (EU MDR 2017/745)
Single-Use Devices (SUDs) are indispensable in the healthcare sector, providing essential tools for medical procedures. While SUDs are...
Sep 15, 20234 min read
Conformity Assessment of Medical Devices under EU MDR
The world of medical devices is a realm of constant innovation, where the development of new technologies has the power to transform...
Sep 11, 20233 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 9, 20232 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 8, 20234 min read
Navigating Switzerland's Medical Device Regulations: The Role of Swiss Authorized Representatives
The Mutual Recognition Agreement (MRA) had been a pivotal instrument in fostering bilateral trade between Switzerland and the European...
Sep 6, 20234 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 4, 20231 min read
Enhanced Digital (SEO) Strategies for a USA based Surgical Instruments Company
Summary Boosting Surgical Company's digital presence, driving improved website performance, and fortifying their reputation in the...
Aug 30, 20233 min read
MedTech Incubators and Accelerators in India: A Guide for Innovator & Early Stage Entrepreneurs
Incubators and accelerators stand as two essential pillars for fostering creativity and accelerating business expansion for early stage entr
Jul 31, 20235 min read
Medical Device Regulations in Colombia: A Comprehensive Guide
In 2023, the Medical Devices market in Colombia is expected to achieve an impressive revenue milestone of US$2.00 billion. This reflects...
Jul 31, 20232 min read
Asia - Contract Staffing & Hiring for Regulatory Affairs (Pharmaceuticals & Devices)
Artixio’s Contract Staffing solutions in Asia can be tailored to suit your needs and long term Regulatory Affairs strategy
Jul 21, 20237 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, 202310 min read
FAQs – Australia (TGA) Regulations for Medical Device Registration
The regulatory authority responsible for medical device registration in Australia is the Therapeutic Goods Administration (TGA)
Jul 21, 202310 min read
FAQs - Taiwan (TFDA) Regulations for Medical Device Registration
The regulatory authority responsible for medical device registration in Taiwan is the Taiwan Food and Drug Administration (TFDA).
Jul 20, 202310 min read
FAQ - Singapore (HSA) Regulations for Medical Device Registration
The Health Sciences Authority (HSA) is the regulatory authority responsible for medical device registration in Singapore.
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