CANADA: MDEL license renewal within 1 April and commissions update for MD
It is approaching the deadline for the MDEL renewal, the Medical Device Establishment Licence in Canada. MDEL license renewal within 1 [...]
22 02 2021
22 02 2021
22 02 2021
22 02 2021
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 relevance [...]
01 02 2021
01 02 2021
First MDR Certificate for 3DIEMME with the support of Thema
Great satisfaction for the 1st MDR Certificate obtained by 3DIEMME with Thema support With great pride and satisfaction, we communicate that [...]
25 01 2021
25 01 2021
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 to [...]
25 01 2021
25 01 2021
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 (CGII), [...]
25 01 2021
25 01 2021
AUSTRALIA: TGA priority applicant guidelines for Medical Devices and IVDs
On 2 December 2020, the TGA priority applicant guidelines for Medical Devices and IVDs were published: “Priority applicant guidelines for Medical Devices [...]
19 01 2021
19 01 2021
Impending deadlines: what do you need right now?
Discover Thema services to reach your objectives in time! Impending deadlines: what do you need right now? The regulation of Medical [...]
16 12 2020
16 12 2020
EUROPE: MDCG guidance on classification of In Vitro Diagnostic Medical Devices (IVD)
Last November 2020, the Medical Device Coordination Group (MDCG) published the guideline MDCG 2020-16 “Guidance on Classification Rules for in vitro [...]
16 12 2020
16 12 2020
USA: FDA issues Certificate for Devices not Exported from U.S.A. (CDNE)
Last month, the U.S. Food & Drug Administration (FDA) published online information on Certificate for Device Not Exported from the United [...]
16 12 2020
16 12 2020
SINGAPORE: next introduction UDI system for Medical Devices
Last 19 October 2020 the Health Sciences Authority (HSA), Singapore’s Regulatory Authority, announced that it will be introduced a UDI (Unique [...]
