USA: public FDA discussion document to improve cybersecurity in the maintenance of Medical Devices
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has published “Strengthening Cybersecurity Practices [...]
EU: MDCG 2021-13 Q&A registration in EUDAMED for actors not considered Manufacturers, Authorised Representatives or Importers according to MDR and IVDR
In June 2021, the Medical Device Coordination Group (MDCG) published the Q&A Guide to answer some of the most significant [...]
EU: amendment of MDR (EU) 2017/745|OJ L241/7 08/07/2021
On 8 July 2021 an amendment to the Regulation on Medical Devices MDR (EU) 2017/745 was published in the Official [...]
EUROPE: MDCG and IMDRF guidelines updated for MDR and IVDR
One month has passed since the date of full application of the MDR Regulation (EU) 2017/745 for Medical Devices and [...]
AUSTRALIA: TGA reclassifies Medical Devices
The Australian Therapeutic Goods Administration (TGA) has issued guidelines for the reclassification of Medical Devices and relative temporary arrangements. TGA [...]
SAUDI ARABIA: new market access procedure coming soon
The Kingdom of Saudi Arabia (KSA) has officially introduced the new Medical Devices Regulation, which is expected to come into [...]
TAIWAN: implementation of the new Medical Devices Act on 1 May 2021
On 1 May 2021 the Medical Devices Act entered into force, replacing the previous regulatory framework for Medical Devices in [...]
MDCG: new useful guidance on Medical Devices
The Medical Device Coordination Group (MDCG) has recently published some useful guidance on Medical Devices to provide information and support [...]
RUSSIA: updates in the EAC Certificate Registration Procedure
From January 2021 new requirements have come into force to obtain the EAC Certificate (EurAseC Conformity), which is essential for [...]
EUROPE: published new guidelines MDCG 2021-3 on Custom-Made Devices
The Medical Device Coordination Group (MDCG) published the document MDCG 2021-3 Q&A “Questions and Answers on Custom-Made Devices” to provide [...]
USA: CDRH announces new Biocompatibility Assessment Resource Center
Last month, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced the new electronic Biocompatibility [...]
TURKEY: amendments made to the Regulation on sales, advertising and promotion of Medical Devices
Recently, the Turkish Medicine and Medical Devices Authority ("TITCK") made amendments to the Regulation on sales, advertising and promotion of [...]
INDIA: Ministry proposes ASTM standards for demonstrating compliance with Medical Devices
In the notification published on 5 February 2021 in the Official Gazette, the India’s Ministry of Health and Family Welfare [...]
THAILAND: new THAI FDA rules on device classification and registration
The Thai Food and Drug Administration (Thai FDA) has issued new rules on classification and registration of Medical Devices and [...]
USA: exemptions from Premarket Notification 510(k) requirements for some Medical Devices
In order to increase the availability of certain Medical Devices in contrast to the COVID-19 health emergency, on January 15, [...]
SOUTHEAST ASIA: Medical Devices regulatory updates in Philippines, Vietnamese and Malaysian markets
Below there are the latest news on the regulatory updates of Medical Devices in some South-East Asian markets of particular [...]
BREXIT: how to register Medical Devices at MHRA
Following BREXIT, from 1 January 2021 the United Kingdom is no longer a member of the European Union. How [...]
CANADA: new PMS requirements for Medical Devices published
On 23 December 2020, new Post-Market Surveillance (PMS) requirements for Medical Devices were published in the Canada Gazette, Part II [...]
