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Nov 27, 20234 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 26, 20233 min read
Regulation of Health Supplements in Singapore
Health supplements play a significant role in supporting human body functions and maintaining well-being. However, navigating through the...
Nov 25, 20233 min read
Medical Device Regulations in India (CDSCO)
India's healthcare sector is witnessing significant growth, with a burgeoning market for medical devices. The regulation of medical...
Nov 23, 20233 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 22, 20236 min read
Health Canada Cosmetic Regulations in Canada
Cosmetics play a vital role in our daily routines, but their safety and compliance with regulations are of utmost importance. The...
Nov 20, 20236 min read
Understanding Quality System Regulations (QSR) under 21 CFR Part 820
The Quality System Regulations (QSR), outlined in 21 CFR Part 820, are critical guidelines established by the U.S. Food and Drug...
Nov 17, 20234 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 16, 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 13, 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 10, 20235 min read
Taiwan Food and Drug Administration (TFDA) Drug Regulations in Taiwan
Taiwan, with its growing pharmaceutical market, is an attractive destination for drug manufacturers looking to introduce their products....
Nov 9, 20236 min read
CDSCO Regulation of Cosmetics in India
Cosmetics play a significant role in our daily lives, enhancing our beauty and self-esteem. In India, the cosmetics industry has...
Nov 8, 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 5, 20232 min read
Cosmetics Labeling for COFEPRIS compliance in Mexico
NOM-141-SSA/SCFI-2012 is a Mexican standard that establishes labeling requirements for prepackaged cosmetic products. This standard...
Nov 4, 20232 min read
Artixio’s Regulatory Support for a Chinese Pharmaceutical Manufacturer in Mexico
A case study outlining Artixio’s Regulatory Support for a Chinese
Pharmaceutical Manufacturer in Mexico.
Nov 3, 20233 min read
Notice of Operation : Essential Pre-requisite for registration of products with COFEPRIS, Mexico
A Notice of Operation in Mexico, or Aviso de Funcionamiento en México, is a document that must be filed with the Mexican Ministry of...
Nov 2, 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...
Oct 31, 20235 min read
National Pharmaceutical Regulatory Agency (NPRA) Regulation of Health Supplements in Malaysia
The health supplements market in Malaysia has been witnessing robust growth. With increasing health consciousness and a growing aging...
Oct 30, 20233 min read
DIGIPRIS: Mexico COFEPRIS Digital Platform for Product Registrations and Regulatory Submissions
The DIGIPRIS system (Sistema Digital de Procesos y Servicios Regulatorios, or Digital System of Regulatory Processes and Services) is a...
Oct 29, 20235 min read
US FDA Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
The Modernization of Cosmetics Regulation Act (MoCRA), which was signed into law on December 29, 2022, is a significant milestone in the...
Oct 27, 20234 min read
Regulation of Medical Devices with Philippines Food and Drug Administration (PFDA), Philippines
In the Philippines, the medical device industry relies heavily on imports for its products. Â Whether these products are made...
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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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