- 29 April 2022
The Medical Device Coordination Group (MDCG)
on 24 March 2022 released the updated guidelines on the Summary of Safety
and Clinical Performance updated (SSCP) for Manufacturers and Notified
Bodies. It is the Revision ...
- 29 April 2022
On 10 January 2022, the Indonesian Ministry of
Health, following Regulation 14 of 2021, announced that it had introduced a simplified
registration process for certain Class A Medical Devices.
It is no longer ...
- 29 April 2022
BRAZIL: UDI’s systema deadlines and Software as Medical Devices requirements (SaMD)
RDC Resolution No. 591/2021 came into force on 10
January 2022. It requires medical devices regulated by ANVISA – the Brazilian
Regulatory ...
- 28 March 2022
Last month, the Medical
Device Coordination Group (MDCG) published two
important guidelines.
MDCG 2022-3 “Verification of manufactured class D IVDs by notified bodies” is
the first one and provides information on conformity assessment procedures
for ...
- 28 March 2022
Based on the “Fees in Respect of Drugs and Medical Devices Order”, Health Canada published the updated fees for Medical Devices applicable as from 1st April 2022.
Updates fees for Medical ...
- 28 March 2022
Japan’s Ministry of Health, Labour, and Welfare (MHWL) has updated its processes and procedures in order to officially accept MDSAP reports starting from 1st April 2022, as evidence of conformity ...
