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. Whether these products are made...
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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 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 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 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 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 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...
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 30, 20233 min read
Class I Medical Devices and CE Marking: Compliance Essentials
The European Union (EU) boasts one of the most stringent regulatory frameworks for medical devices in the world. For manufacturers...
Sep 29, 20235 min read
Navigating the Complex World of Combination Products: Understanding EU MDR Article 117
In the world of healthcare, many patients benefit from the use of combination products – medical devices that incorporate pharmaceuticals...
Sep 28, 20234 min read
Certifying Medical Devices in the EU: The Crucial Role of Notified Bodies under MDR and IVDR
In the ever-evolving world of medical devices, Notified Bodies play a pivotal role in ensuring the safety and efficacy of products...
Sep 27, 20234 min read
The CE Mark is Just the Beginning: Post-CE Compliance under EU MDR
The introduction of the European Union Medical Device Regulation (EU MDR) 2017/745 marked a significant milestone in the world of medical...
Sep 25, 20234 min read
EU MDR Compliance: Navigating the Essential EUDAMED Modules
The European Medical Devices Regulation (EU MDR) has ushered in a new era of regulations for medical devices in the European Union. Among...
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