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...
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Oct 10, 20236 min read
Medical Device Registration in Singapore – Pre-submission Meetings with Health Sciences Authority
Singapore's reputation as a global healthcare and innovation hub has made it an attractive destination for medical device manufacturers...
Oct 8, 20235 min read
Medical Device Registration in Singapore : Evaluation Processes by Health Sciences Authority (HSA)
The realm of medical device registration in Singapore comprises a intricate network of rules, recommendations, and procedures designed to...
Oct 7, 20236 min read
Medical Device Registration in USA by US Food and Drug Administration (US FDA)
Medical Devices Regulatory Overview in USA The responsibility for overseeing the regulations of medical device companies involved in the...
Sep 13, 20233 min read
Nutraceutical Regulation in Japan
Over recent decades, the adoption of dietary supplements and nutraceuticals for mitigating health risks and improving well-being has...
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 7, 20233 min read
Nutraceutical Regulations and Registration in Colombia (INVIMA)
The Colombian nutraceutical market is likely to continue growing as consumers increasingly prioritize their health and well-being. As the...
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 6, 20235 min read
Biologics and Biosimilar Regulations and Registration in South Korea
The Korean pharmaceutical market is estimated to be worth $24.3 billion in 2019, and between 2015 and 2019, it grew at a compound annual...
Aug 31, 20235 min read
Biologics and Biosimilar Regulation and Registration in Japan (PMDA)
With the exception of the United States, Japan's biosimilar business, with a market value of $140 million, accounted for just 5% of the...
Aug 30, 20233 min read
Nutraceutical Regulation and Registration in India (FSSAI)
The Indian population's increasing trust in immunity-boosting supplements has significantly transformed buying behaviors and market...
Aug 29, 20233 min read
Nutraceutical Regulation and Registration in Australia (TGA)
In Australia, products categorized as 'complementary medicines' encompass a range of medicinal items, including herbs, vitamins,...
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 25, 20233 min read
Nutraceutical Regulations and Registration in Vietnam (MoH)
Vietnam's nutraceutical market has been steadily expanding as the population becomes more health-conscious and seeks products that can...
Aug 24, 20233 min read
Nutraceutical Regulation and Registration in South Korea (MFDS)
Nutraceuticals, a fusion of "nutrition" and "pharmaceuticals," represent a burgeoning sector at the intersection of food and medicine....
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 21, 20234 min read
Nutraceutical Registration and Regulations in the UK (MHRA): A Comprehensive Guide
The global nutraceutical industry has experienced remarkable growth in recent years, largely due to a rising consumer focus on health and...
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...
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