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Oct 26, 20234 min read
Thailand FDA Regulations of Food manufactured or imported in Thailand
In Thailand, the oversight of food regulation primarily rests with various government agencies and departments tasked with ensuring food...
Oct 25, 20235 min read
Health Sciences Authority (HSA) Medical Device Dealers Licenses in Singapore
The Health Sciences Authority (HSA) functions as the regulatory authority responsible for overseeing medical devices within the country,...
Oct 24, 20239 min read
The Mexico COFEPRIS Good Manufacturing Practices (GMP) Requirements for Cosmetics
The Mexican Official Standard NOM-259-SSA1-2022 outlines comprehensive regulations covering various aspects of good manufacturing...
Oct 23, 20236 min read
The Q-Submission Meetings for Medical Devices with US FDA
The US Food and Drug Administration (US FDA) Q-Submission Program serves as a vital channel for medical device manufacturers to engage...
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 20, 20234 min read
US FDA RFD and Pre-RFD Submissions for Combination Products in USA
The healthcare landscape is in a perpetual state of transformation, and as a consequence, there is a noticeable surge in the development...
Oct 19, 20234 min read
Medical Device Regulations in India : A Closer Look at CDSCO Application Forms
The Central Drugs Standard Control Organization (CDSCO) in India plays a pivotal role in regulating the manufacture, sale, and...
Oct 18, 20236 min read
Medical Device Regulations in Thailand (Thai FDA) : Device Registration Pathways
Thailand is renowned for its stunning landscapes, rich culture, and world-class healthcare. The country has been steadily growing as a...
Oct 17, 20236 min read
Health Sciences Authority Medical Device Regulations : Advertisements and promotions in Singapore
The world of advertising is dynamic and ever-evolving, especially when it comes to the promotion of medical devices. Ensuring that these...
Oct 15, 20236 min read
Medical Devices Regulations in Mexico: COFERIS QMS compliance Requirements under NOM-241-SSA1-2021
Mexico, a thriving and expanding market for medical devices, presents its distinct regulatory framework that manufacturers must adeptly...
Oct 14, 20234 min read
The Road to US FDA Compliance: Managing US Agent for Medical Devices
To successfully navigate the regulatory requirements of the US FDA and establish a presence in the US market, foreign manufacturers are...
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 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 9, 20234 min read
Understanding the Role of PRRC under EU MDR and IVDR
The advent of the EU Medical Device Regulations (EU MDR) and In-Vitro Diagnostic Regulation (IVDR) signals a new era of intensified...
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...
Oct 5, 20234 min read
Types of Medical Device Approval Licenses Issued by CDSCO in India
The healthcare sector holds a vital position in safeguarding the health of a nation's people, with the utmost importance placed on 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 2, 20233 min read
Artixio Helps USA Pharma Company Register New Drugs on Time & on Budget Through Regulatory Staffing
Regulatory affairs (RA) is a critical function for pharmaceutical and medical device companies in the USA.
Oct 2, 20235 min read
Key Players in Medical Device Regulation: Economic Operators under EU MDR and IVDR
In the rapidly evolving landscape of medical device regulations, understanding the roles and responsibilities of economic operators is...
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