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

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

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...

Singapore Health Sciences Authority (HSA) final document presents the specific requirements applicable for NGS IVDs that are to be...

Following the consultation with industry since Aug 2016, the Singapore National Environment Agency (“NEA”) gazette additional controls...

Medical Device Pre-market Registration A submission guide that maps the various modules in our MEDICS system to the ASEAN CSDT dossier...

SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants BIA-ALCL is a cancer of the immune system and not a type of breast...

The International Medical Device Regulators Forum (IMDRF) is a forum for regulators to discuss directions in medical device regulatory...

Singapore Health Sciences Authority (HSA) shared the following updates on 28 March 2019: Update to the GN21 Change Notification (CN)...

The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...

Executive Summary: The latest Asian Medtech Associations Regulatory Networking discussions extended to news from Malaysia, Vietnam,...

In recent ASEAN meeting, Singapore HSA has reiterated the country's initiative to enhance the facilitation of immediate market access....

The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...

Singapore HSA has recently announced possible changes to the guidance documents GN-17 and GN-18. These changes are currently opened for...

AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...

Singapore: HSA preparing manufacturer for the new ER IMDRF elements and cybersecurity. The new version Essential Requirements (ER)...

Local Compliance HSA has recently set up an Innovation Office, a regulatory advisor for product development, in pursuit of greater...

ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines,...

Singapore The Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality,...