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 […]
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Australia (TGA) Medical Devices Regulations and Registration Process
Medical device is an instrument, apparatus or machine intended to for the use of diagnosis, treatment or prevention of any
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
Medical Device Risk Classification Under EU MDR
The European Union Medical Device Regulation (EU MDR) represents a significant overhaul of the regulatory framework for medical devices in
Medical Devices Regulations in European Union (EU MDR)
The medical devices market in Europe has exhibited impressive value, surpassing USD 140.07 billion in 2022. Experts predict that this
Importing Medical Devices in Thailand: Process and Regulations
In today’s globalized healthcare landscape, the importation of medical devices plays a crucial role in ensuring cutting-edge technologies and life-saving
Medical Device Regulations & Registration Process in Thailand
The production of medical devices in Thailand was estimated around 4.9 million U.S. dollars in 2022. The total market size