IMDRF: Consultations being held on guidance documents concerning adverse event reporting, labelling and UDI ISO: Latest revisions of ISO...

International - ICH Guidelines Implementation Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018 China - CDE...

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...

Philippines: On 6 June 2018, the Philippines FDA released Memorandum No. 2018-011, revealing the regulation criteria of the three...

Malaysia: The Medical Device Authority has decided for implementation of an additional 3 year transition period for establishments to...

Saudi Arabia: Saudi Food and Drug Authority (SFDA) has revised the product shelf life requirements to better facilitate the entry of...

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

European Union: The countdown until the EU Medical Device Regulation (MDR 2017/745 EU) takes hold in late May 2020 is heating up. While...

Malaysia: Medical Device-Drug-Cosmetic Interphase (MDDCI) Products are those products that are not clearly defined as a medical device or...

ASEAN: This month's ASIAN MEDTECH ASSOCIATION's REGULATORY networking discussions cover the current progress of the Thai medical device...

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

The Saudi Food and Drug Authority (SFDA) informs medical devices manufacturers and their Authorized Representatives that Marketing...

HSA has revised its guidance documents and the changes will be taking place from 1 June 2018 onwards. ARQon has collated a list of the...

“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing...

Australia: Changes to the therapeutic goods advertising framework Australia: Guidance on updating an existing Class 1–3 in-house IVD...

EU/UK: Withdrawal of the UK and EU rules in the field of industrial products EU: Commission proposes Member State cooperation on Health...

Canada: Medical device fees increased by 2% from 1 April 2018 Canada: New Digital Health Review Division to be established Canada:...

Brazil: Acceptance of third-party audits for Brazilian GMP certification extended to local and Mercosur manufacturers Brazil: New...

IMDRF: Final guidance documents published IMDRF: Consultation held on ‘Essential Principles of Safety and Performance’ of medical devices...