Australia: Proposed changes to the Essential Principles for safety and performance
Australia: Proposed changes to the requirements for systems and procedure packs
Australia: Feedback sought on the regulation of certain self-testing IVDs in Australia
Bahrain: Draft ‘Technical Regulation for Medical Devices and Accessories’
China: CMDE expands list of medical devices exempt from clinical trials
China: New UDI requirements have come into force
China: Mandatory national standard on ophthalmometers circulated for comment
Hong Kong: Medical Device Control Office renamed
Hong Kong: Expedited approval of Class II/III/IV general medical device listing applications is trialled
Hong Kong: Trial assesses acceptance of Korean marketing approvals in support of an MDACS listing application
India: All medical devices to be regulated as drugs under new proposal
Indonesia: Halal product certification for medical devices to start in October 2021
Korea (Republic of): Proposed amendments to ‘Medical Devices Act’
Korea (Republic of): Changes proposed to ‘Enforcement Regulation of the Medical Devices Act’
Malaysia: Control of orphaned, obsolete and discontinued medical devices
New Zealand: New fee for Regulatory Statements to Foreign Governments
New Zealand: Changes are made to the medical device adverse event reporting process
Philippines: Pilot study to evaluate capability of companies to comply with ASEAN technical requirements for product registration
Russia: New quality control and safety monitoring requirements for medical activities
Saudi Arabia: New marketing authorisation fees effective 1 December 2019
Saudi Arabia: Evidence of regulatory compliance in other jurisdictions no longer applicable after 1 January 2020
Saudi Arabia: New guidance published on adverse event reporting
Saudi Arabia: Content of labelling for soft contact lenses and contact lens solutions
Saudi Arabia: Guidance on electronic instructions for use (e-IFU)
Saudi Arabia: Expedited approval process proposed for innovative medical devices
Saudi Arabia: Draft guidance on criteria for bundling/grouping medical devices
Saudi Arabia: Proposed list of SFDA-recognised standards
Singapore: Requirements for the registration of next generation sequencing in vitro diagnostic medical devices (NGS IVDs) are drafted
South Africa: SAHPRA is on track to initiate product registration
Taiwan: Changes to classification names/descriptions in The Regulations for Governing the Management of Medical Device
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