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 […]
MedTech, US FDA Compliance
US Agent Responsibilities & Importance For FDA Regulatory Success
The United States Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and effectiveness of medical
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
Global Regulation of Cultivated Meat
Cultivated meat is changing the future of food. As the global population grows and meat demand rises, traditional livestock farming
What Is a Marketing Authorization Holder (MAH)?
A Marketing Authorization Holder (MAH) is an entity—whether an individual, company, or non-profit organization—that holds the regulatory approval to distribute,
HSA Regulation of Topical Antiseptics in Singapore
Antiseptics are essential tools in maintaining hygiene and preventing infections, both in everyday life and healthcare settings. In Singapore, the
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