top of page
Search
Dec 8, 20236 min read
The Cosmetic Product Notification(CPN)to National Pharmaceutical Regulatory Agency (NPRA), Malaysia
In the vibrant world of cosmetics, Malaysia is a key player with a diverse and thriving beauty industry. As consumers continue to seek...
Oct 21, 20233 min read
Local Representative for MDR in Mexico:Mexican Registration Holder (MRH) for COFEPRIS Communications
In recent years, Mexico has emerged as a highly attractive destination for businesses looking to expand their operations, particularly in...
Oct 11, 20234 min read
Medical Device Registration in USA : 510(k) Registration with US FDA
In the realm of medical devices, regulatory compliance is paramount to ensure patient safety and effective product performance. The...
Oct 4, 20236 min read
The US Agent: Your Essential Partner for FDA Regulatory Success
The United States Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and effectiveness of medical devices,...
Oct 1, 20233 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...
Sep 1, 20237 min read
Biologics and Biosimilars Regulation and Registration in India (CDSCO)
The size of the Indian biosimilars market, which was anticipated to be worth $349 million in 2022, is expected to increase to $2108...
Aug 28, 20235 min read
Biologics and Biosimilar Regulations and Registration in the European Union (EU) (EMA)
In 2022, the Europe biosimilar market had a value of almost USD 4601.56 million. In addition, it is anticipated that the biosimilar...
Aug 23, 20235 min read
Biologics and Biosimilars Regulations and Registration in Mexico (COFEPRIS)
Mexico is the second-largest drug market in Latin America, after Brazil. With a compound annual growth rate (CAGR) of 38.7%, the Mexican...
Aug 22, 20234 min read
Pharmaceutical Regulations and Registration in Colombia (INVIMA)
Colombia stands out for its pharmaceutical industry's ability to offer a diverse portfolio of products. Approximately half of the sales...
Aug 18, 20235 min read
Biologics and Biosimilars Regulations and Registration in China (NMPA)
In China, 40% of the biologics market comprises biosimilars. The usage of biosimilars in oncology has increased as cancer overtook heart...
Aug 15, 20233 min read
Nutraceutical Regulations and Registration in Hong Kong (FEHD)
Hong Kong stands out as a dynamic hub in Asia's health supplement market. The trend of consumers embracing a diverse range of dietary...
Aug 9, 20235 min read
Biologics and Biosimilars Regulations, Registration Process in the USA (FDA)
The size of the U.S. biosimilars market, estimated at USD 6.73 billion in 2021, is expected to increase by USD 9.48 billion in 2022 and...
Aug 7, 20233 min read
ANVISA Nutraceutical and Dietary Supplements Regulations in Brazil
In recent years, there has been a growing interest in nutraceuticals and dietary supplements as individuals seek to improve their overall...
Aug 4, 20235 min read
Pharmaceutical Regulations in Japan
In the Japanese pharmaceutical industry, the journey of developing a new drug is marked by formidable challenges. Statistical data...
Aug 3, 20234 min read
Regulations for Pharmaceutical Registration in Hong Kong
The pharmaceutical market in Hong Kong has reached a significant size, estimated to be around $2.3 billion. This figure highlights the...
Aug 1, 20237 min read
Pharmaceutical Regulations in European Union
The European pharmaceutical market is expected to reach USD 432.12 billion by 2028, growing at a CAGR of 5.4%. Cancer therapeutics is...
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 29, 20237 min read
Pharmaceutical Regulations and Registration in Vietnam
Vietnam is the 7th fastest growing middle-class population in the world and aims to achieve an upper middle class income status by 2035,...
Jul 20, 20238 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...
Jun 26, 20235 min read
Mexico (COFEPRIS) Regulations for Medical Device Registration
COFEPRIS in Mexico governs the regulations for registration of medical devices
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.
bottom of page