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...

China Clinical Requirements Update On 13th December, the CMDE published the Public Consultation (Deadline: 13 Jan 2020) on “Technical...

Singapore Launch of OSCAR System for FSCA Reporting As part of HSA’s on-going effort to improve efficiency in our processes, HSA is...

Breast Implant regulation: B.E. 2562 Main content revision from regulation B.E. 2540 Signed date: 7 November 2019 Announced date: 18...

Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft for Software Developer and Software in...

Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft for Software Developer and Software in...

WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (WHO SAGE IVD) The World Health Organization (WHO) has established a...

In September 2019, Malaysia halal medical device standard is published, known as: MS 2636 : 2019 Halal Medical Device - General...