Jun 24, 2020
Australia and Oceania
In relation to difficulties associated with the Coronavirus or COVID-19, The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, issued a notice dedicated to the delay in the implementation of certain...
Read More
Feb 28, 2020
Saudi Arabia
The Saudi Food & Drug Authority, the agency responsible for medical device regulation in the Kingdom of Saudi Arabia, issued draft guidance dedicated to the classification of the combination products. The document will be available for public comments since the...
Read More
Feb 25, 2020
Uncategorized
The Medical Device Authority (MDA), the department of the Ministry of Health in Malaysia, published draft guidance dedicated to notification of refurbished medical devices. The document is intended to assist industry representatives and provide them with the...
Read More
Jan 30, 2020
Asia
South Korea’s Ministry of Food and Drug Safety (MFDS) has issued two guidance dedicated to certain aspects of medical device regulation. One pertains to imported medical devices and the other to scarce and unique devices. These documents had been previously...
Read More
Jan 15, 2020
North America
The Food and Drug Administration (FDA), the US agency responsible for medical device regulation, issues guidance dedicated to requirements for certain Class II applications. Medical Devices for Percutaneous Coronary Intervention The scope of the guidance released by...
Read More