Asia, Africa and Middle East - Feb 2021
Australia: Regulatory changes for custom-made devices apply from 25 February 2021
Australia: Reforms to the regulation of software-based medical devices effective 25 February 2021
Australia: Updated guidance published on medical device patient information leaflets and implant cards
Australia: Guidance released to support submission of Declaration of Conformities for Class I non-sterile, non-measuring medical devices and Class 1 IVDs
Australia: Guidance on priority applicant determinations is updated
China: New updates to ‘Medical Device Classification Catalogue’
China: ‘Regulations on the Supervision and Administration of Medical Devices (Revised Draft)’ passed
China: Technical guidelines drafted on use of overseas IVD clinical trial data
China: ‘Technical Guidance on Real-World Data for Clinical Evaluation of Medical Devices (Trial Implementation)’
China: Five general naming guidelines issued
China: Technical review guidelines issued for the registration of seven types of IVD
China: Comments sought on draft standards for copper-bearing contraceptive intrauterine devices and certain medical electrical equipment
Egypt: Standard drafted for external limb prostheses and external orthoses
Hong Kong: Trial extended on expedited approval of Class II/III/IV general medical device listing applications
Hong Kong: Trials to assess acceptance of Chinese or Korean marketing approvals in support of an MDACS listing application have been extended
India: Six-month grace period for certain existing importers/manufacturers of nebulisers, blood pressure monitoring devices, digital thermometers and glucometers
India/UK: MoU on co-operation in the field of medical product regulation
Japan: QMS Ministerial Order to align with ISO 13485
Japan: Partial revision of the ‘Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices’
Kenya: New standard sets specifications for kidney trays
Korea (Republic of): Proposed amendments of the rules concerning GMP for medical devices and IVDs
Malaysia: New guidance on medical face masks and respirators
Malaysia: Draft guidance on general medical device groupings
Saudi Arabia: Detailed fees that apply to MDMA variations
Saudi Arabia: Marketing authorisation applications may still be submitted via GHTF route
Singapore: UDI implementation to start in 2022
South Africa: New fees payable to SAHPRA
Taiwan: On-site inspections of foreign manufacturers postponed due to COVID-19
Taiwan: Rules drafted for issuing medical device licences, listings, and annual declarations
Taiwan: ‘Enforcement Rules of Medical Device Act’ have been drafted
Taiwan: Comments solicited on draft UDI requirements for medical devices
Taiwan: Regulations drafted for border inspections and examination of imported condoms and medical masks
Uganda: Draft standards for medical cotton swabs, adhesive plasters, alcohol swabs, and medical safety goggles
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