WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (WHO SAGE IVD)

The World Health Organization (WHO) has established a Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) to act as an advisory body to matters of global policies and strat...

In September 2019, Malaysia halal medical device standard is published, known as:

MS 2636 : 2019 Halal Medical Device - General Requirements.

This MS 2636 standard is a voluntary basis and a value added guidelines to the industry to serve the users requiring halal affirm...

MDR 'Up-Classified' Class I Medical device Extension

European Parliament finalized the EU MDR Second Corrigendum following ENVI and INTA committees announcement on Monday 16 December 2019 and published the Second Corrigendum on 17 December 2019. Click here for...

Thai FDA issued an announcement for alternative Concise Evaluation route for registering Notified and Licensed medical device, including IVD devices. This alternative route allows Manufacturer to use the reference agency approval document instead of the Country of Orig...

The Vietnamese MOH has released the proposed amendment in end 2019 to the Vietnamese medical device industry while waiting for the documents to be officialized.

These will further amend the Decree No. 169/2018/ND-CP ("Decree No. 169") and Decree No. 36/2016/ND-CP relati...

HSA final document presents the specific requirements applicable for NGS IVDs that are to be submitted for registration. The scope of this document covers both NGS based IVD tests intended to aid in diagnosis of individuals with suspected germline or somatic mutation-r...