In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...

A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). A suite of guidance ...

The Centre is reclassifying 1,178 medical devices. This move is expected to enhance clarity and support the growth of India’s ...

Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, ...

South China's Guangdong Province has released a regulation, demanding that hotels must ensure that guest rooms are free of ...

Over the past month, Australians have noticed that their iOS devices, including iPhones and iPads, have gained an odd string ...

India's medical device industry, valued at US$12 billion, has become a growing hub for innovation, attracting venture capital ...

Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.” ...

Clinical evaluation is a mandatory process under the Regulation (EU) MDR 2017/745. It is a prerequisite to obtain a CE marking certification, which enables manufacturers to lawfully market their ...

New Delhi: In an attempt to bring regulatory uniformity in medical devices, the government plans to classify around 1,178 medical devices into four categories based on their risk approach under ...

In recent years, new regulation has been top-of-mind for medtech companies wishing to continue marketing their products in ...

Federal regulators want drivers for a study to find out if flares, fuses and warning triangles do enough to reduce crashes ...