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
Pharmaceutical Regulations and Registration in Australia
The pharmaceutical market in Australia is projected to reach USD 9.78 billion by the end of the year 2023 with
Biologics and Biosimilars Regulations and Registration in Australia (TGA)
The Australian healthcare system has transformed with the availability of biologic and biosimilar medications. The market for Australian biosimilars, which
Pharmacovigilance In Clinical Trials
Clinical trials are an integral part in the development of medical products. It is done to ensure that the product
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
EMA’s Clinical Trial Regulations (EUCTR) in European Union
The new EU Clinical Trial Regulation (CTR) 536/2014, which came into effect on January 31, 2022, represents a significant overhaul
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