The WCO reminds the general public to exercise extreme caution when purchasing critical medical supplies from unknown sources,...

The World Health Organization (WHO) supports the implementation of reliance on other regulators’ work as a general principle, making...

RDC 232/2018 - Unique Device Identification (UDI) UDI will be enforced on 15 June 2020 that require product label with traceability using...

Australia: Fees and charges proposed for 2020–2021 Australia: Regulatory changes for software, personalised medical devices and IVD...

Argentina: New rules published for the control of medical devices Brazil: What changes are expected in 2020 for Brazil’s medical device...

EU: Corrigenda to MDR and IVDR are approved EU: EUDAMED delayed by two years EU: Several MDCG guidance documents have been finalised...

Canada: New Medical Devices Directorate established at Health Canada Canada: Final guidance published on Software as a Medical Device...

This issuance aims to provide information regarding the acceptance of applications based on AO 2018-0002, validity of issued Certificate...

There will be no transition period for Class I medical devices which remain in Class I under MDR. From 26th May 2020 onwards, the...

This is the latest gazettement of the Medical Device Regulations pursuant to the Medical Device Act 2012 (Act 737). The gazettement took...

Health Sciences Authority (HSA) has finalized the specific requirements for registration of Next Generation Sequencing based In-vitro...

With effect from 12 Feb 2020, two new chemicals adopted for listing under Annex A of the Stockholm Convention (SC) will be controlled as...

To comply with new MDR requirements in an efficient manner before the relevant international standard is available, MedTech Europe...

This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their...

Control Of Orphaned, Obsolete and Discontinued Medical Device In Hospital, Healthcare Facilities Institution Or Any Related Facilities...

Date 12 February 2020 (Wednesday) | 8.00 AM – 5.30 PM (TRAINING) 13 February 2020 (Thursday) | 8.00 AM – 10.30 AM (EXAMINATION) Venue...

Pursuant to the Law on the Government Organization dated 19/06/2015; in consideration of the proposal of the Minister of Health, the...

1) The Resource Sustainability Act (RSA), introduced by the Ministry of the Environment and Water Resources (MEWR), is an integral part...

Taiwan Cybersecurity Requirements Update On 21st November, the Taiwan Food and Drug Administration (TFDA) published the "Medical Device...

Australia Personalised Medical Device Update The Therapeutic Goods Administration (TGA) made acknowledgement to those who gave a response...