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,...
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- 3 days ago
- 3 min
Medical Device Regulations in India
India's healthcare sector is witnessing significant growth, with a burgeoning market for medical devices. The regulation of medical...
- 5 days ago
- 3 min
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 17
- 4 min
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
- 4 min
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
- 4 min
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 8
- 4 min
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 2
- 4 min
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 27
- 4 min
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...
- Oct 25
- 5 min
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
- 6 min
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
- 3 min
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
- 4 min
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
- 6 min
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
- 6 min
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
- 6 min
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
- 4 min
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
- 6 min
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
- 4 min
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
- 5 min
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...
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