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Importing Medical Devices in Thailand: Process and Regulations
Thailand, with its rapidly advancing medical sector, offers a promising market for medical device importers
Oct 3, 20242 min read
Innovative Drug Delivery Systems
While traditional oral pills remain a cornerstone of drug delivery due to their simplicity and familiarity, innovative drug delivery...
Jul 26, 20245 min read
Understanding the State of the Art (SOTA) in Medical Device Clinical Evaluation under EU MDR
The introduction of the European Medical Device Regulation (MDR) has significantly transformed the landscape of medical device clinical...
May 5, 20246 min read
COFEPRIS Makes Changes to Revamp Medical Device Regulations
In a significant regulatory update, Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has introduced new...
Mar 22, 20244 min read
Registration of Pharmaceutical Manufacturing Facilities with MOHAP in UAE
In the United Arab Emirates (UAE), the Ministry of Health and Prevention (MOHAP) plays a crucial role in regulating pharmaceutical...
Mar 19, 20245 min read
Regulatory Contract Staffing in Mexico for a Leading Medical Device Manufacturer
Artixio, a trusted player in the regulatory and commercial arena, provided contract staffing solutions to a global leading medical device...
Mar 7, 20242 min read
Product Classification Application with Ministry of Health and Prevention (MoHAP), UAE
For bringing any pharma product into the UAE market, it is essential to determine the MOHAP product classification and to understand the...
Feb 26, 20246 min read
Case Study: Artixio’s Successful Registration of a Surgical Device with Taiwan FDA
This case study demonstrates Artixio’s Successful Registration of a Surgical Device in Taiwan with FDA.
Feb 7, 20242 min read
Medical Device, Diagnostics Regulations in Taiwan FDA - Frequently Asked Questions (FAQs)
The regulatory authority responsible for medical device registration in Taiwan is the Taiwan Food and Drug Administration (TFDA)
Jan 19, 20246 min read
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
Case Study: Successful Registration of Software as Medical Device (SaMD)assisting Surgical procedure
Client: The client, a pioneering European company specializing in advanced medical technologies, sought regulatory approval for its...
Jan 9, 20242 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...
Dec 2, 20233 min read
Medical Device Regulations and Registration in Canada (Health Canada)
In Canada, the medical devices are regulated by Health Canada under Health Products and Food Branch, Therapeutic Products Directorate,...
Nov 27, 20234 min read
CDSCO Medical Devices Regulations In India
Medical devices are emerging globally and India serves as the 4th largest market in Asia for medical devices. India aims to accelerate...
Nov 25, 20238 min read
Understanding the Significance of Design History File (DHF) in Medical Device Development
The Design History File (DHF) is a crucial component in the development and manufacturing of medical devices. It serves as a...
Nov 23, 20233 min read
ISO 13485:2016 Certification for Medical Devices Quality Management System
In the realm of medical devices, ensuring safety, reliability, and compliance is paramount. The International Organization for...
Nov 17, 20234 min read
QMS Certification through Medical Device Single Audit Program (MDSAP)
In an era of advancing healthcare technology and globalized markets, ensuring the safety, quality, and compliance of medical devices is...
Nov 16, 20234 min read
COFEPRIS Technovigilance of medical devices in Mexico
In the dynamic landscape of healthcare, ensuring the safety and efficacy of medical devices is paramount. As technology continues to...
Nov 13, 20234 min read
Taiwan Food and Drug Administration (TFDA) Medical Device Regulation in Taiwan
Taiwan is a growing market for medical devices, but gaining entry requires strict adherence to Taiwan medical device regulations set...
Nov 8, 20234 min read
Medical Device Registration Pathways in Mexico : Standard and Expedited Review Routes
Mexico is a growing market for medical devices, and medical device manufacturers are increasingly looking to register their products in...
Nov 2, 20234 min read
Insights
Global, Concurrent, Experience Based
Deep dive and engage in insightful discourse driven by concurrent global regulatory scenarios, industry trends and Artixio’s real-time experience across the product value chain. Whitepapers, research articles, landscape reports and case studies to help you stay ahead of the curve.
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