Digital Health The categories of digital health include mobile health (mHealth), Health Information technology (IT), wearable devices, telemedicine, telehealth and personal medicine. Digital health has the potential to improve the ability to accurately diagnose and treat diseases which enhances the delivery of health care for the individual. The applications of these technologies range from general […]

National Medical Products Administration (NMPA) is responsible for the regulation of Medical devices and Pharmaceuticals in China. The predecessor to NMPA was founded in 1998, and renamed as State Food and Drug Administration in 2003. On September 1, 2018 China Food and Drug Administration was replaced by NMPA and it operates under the state jurisdiction […]

In today’s world of healthcare, technology plays an important role in the life cycle of medical devices and software has become an integral part of majority of products that serve both medical and non medical purposes. There are three types of medical devices related to software. Namely, Software as a Medical Device (SaMD), Software in […]

History: The Medical Audit Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to allow third party auditors to conduct a single audit of a medical manufacturer that covers ISO 13485:2016 and the respective regulatory requirements. A working group was established for MDSAP in 2012. Then, IMDRF initiated a three […]

Health Canada’s Medical Device regulations are considered to be one of the stringent requirements in the world for the licensing of medical devices. Regulation of medical devices in Canada is based on the level of risk possessed by the device to the user. This approach helps to balance the need to provide the healthcare system […]

A medical device quality system is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more. Most medical devices will require some form of a Quality Management System (QMS); the complexity of the QMS will vary based on […]

What is EU MDR? The European Union Medical Device Regulation (EU MDR) 2017/745 was published in 2017 by the European Parliament and the European Union Council. The EU MDR regulations are designed to ensure a high level of safety and quality for medical devices manufactured in or supplied to European Union member countries. The regulation […]

-Is this the lifesaver for UK market? When United Kingdom (UK) decided to leave European Union, manufacturers had no clue on which regulations to follow. To avoid the situation, UK put forth a new regulation known as UKCA marking to fill the gaps left by CE marking. This change in regulation will have a massive […]