FDA
The Food and Drug Administration (FDA) has published draft guidance on updates for biocompatibility of certain devices in contact with intact skin. Notes The public consultations period commenced on October 15, 2020, and would last for 60 days during which the...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation...
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Food & Drug Authority, the agency responsible for medical device regulation in the Kingdom of Saudi Arabia, issued draft guidance dedicated to the classification of the combination products.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...
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The Medical Device Authority (MDA), the department of the Ministry of Health in Malaysia, published draft guidance dedicated to notification of refurbished medical devices.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...
North America
FDA’s Center for Devices and Radiological Health (CDRH) holds a meeting to discuss the risks and threats of cybersecurity in medical devices. They describe the unique challenges involved with security and how difficult it is to identify vulnerabilities. The Threat...
