Conformity Assessment of Medical Devices under EU MDR
EU MDR places clear responsibility on manufacturers to prove that their devices meet regulatory expectations. Conformity assessment is the mechanism […]
Regulations of Reusable Medical Devices under EU MDR
The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations for
Role of Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU
If you are responsible for placing a medicinal product on the EU market, you will come across the requirement to
Vietnam Medical Device Registration Process & Regulations
If you plan to sell medical devices in Vietnam, there’s a process you can’t skip. The government checks every product
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
Post-Market Surveillance In Medical Device Regulation
One of the biggest accomplishments in the journey of a drug product is its entry into the market as a
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
MHRA Pharmaceutical Regulations and Registration in the UK
In 2024, the Pharmaceuticals market in the United Kingdom is poised for significant growth, with projected revenue expected to reach