With the In Vitro Diagnostic Medical Device Regulation (IVDR) taking effect on 26 May 2022, around 85% of all IVDs will be required to...

On 20 December 2021, the European Commission announced that instead of the May 2022 deadline for compliance of the new In Vitro...

On 1 December 2021, the European Association for Notified Bodies (Team NB) released a position paper to address concerns regarding the...

On 11 January 2022, the US Food and Drug Administration (FDA) released a draft guidance on notifying them of permanent interruption or...

In November of 2021, the Therapeutical Goods Administration (TGA) released the “Reclassification of medical devices that are substances...

In December of 2021, the Therapeutic Goods Administration (TGA) of Australia released a publication containing the frequently asked...

In October of 2021, the National Medical Product Administration (NMPA) of China announced the “Provision for Self-Testing in Medical...

On 8 November 2022, Vietnam’s Ministry of Health released Decree No. 98/2021/ND-CP. This new document replaced Decree No. 36/2016/ND-CP,...

Indonesia’s Ministry of Health published the “Indonesia Class A Notification Announcement 01.05500242022” on 10 January 2022. Effective...

In January 2022, the Philippines FDA published a new draft regulation on IVD market authorization. The draft was open for public review...

In October 2021, the MDA updated the guidance document on medical devices labeling (MDA/GD/0026). Listed are the changes made in this...

In November 2021, the MDA decided to offer conditional approval to clients seeking to sell Covid-19 self-test kits to better deal with...

The Refurbished Medical Device – Requirements Guidance Document was prepared by MDA to aid manufacturers and authorized representatives...

In July 2013, The Medical Device Centralised Online Application System, abbreviated as MeDC@St, was introducedas a system to manage...

The IVDR was officially published on 5 May 2017 and entered into force on 26 May 2017. The initial implementation date of IVDR was...

Manufacturers of in-house lab-developed tests (LDTs) or in-house in vitro diagnostics (IH-IVDs) have had it quite easy when it comes to...

The European Union has allowed the use of electronic instruction for use (IFU) since March 2013 and provides Regulation 207. Recently in...

The Australian Therapeutic Goods Administration (TGA) has published a new guidance on plans to reclassify medical devices for the...

The European Commission has proposed to postpone the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which would...

Medical Device Coordination Group (MDCG) has published a new guidance on application of MDR requirements to ‘legacy devices’ and to...