510(k) Registration with US FDA – Medical Device Registration in USA
Medical devices regulatory compliance is paramount to ensure patient safety and effective product performance. The 510(k) registration process, overseen by […]
MedTech Insights
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Medical Device Regulations and Registration In UK (MHRA)
Medical Device Regulations and Registration Process in the MHRA United Kingdom (UK) The publicly funded National Health Service (NHS) is
UKRP Responsibilities 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
FAQ – Singapore (HSA) Regulations for Medical Device Registration
Here are answers to some of the Frequently Asked Questions (FAQs) about Singapore regulations for Medical Device registration. FAQs –
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, ensuring their
Template for Literature Search and Screening for Clinical Evaluation of Medical Devices
The literature search and screening report for clinical evaluation of medical devices must be compiled covering following parameters. The accuracy
Medical Devices Regulations & Registration In Indonesia
Although the manufacturing sector for medical devices in Indonesia is constantly growing, Indonesia is an import-driven market for advanced and
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
Conformity Assessment of Medical Devices under EU MDR
The world of medical devices is a realm of constant innovation, where the development of new technologies has the power