Australia: 2018 fees and charges released by the Therapeutic Goods Administration
Australia: Application fee now charged for a Class I medical device ARTG entry
Australia: Therapeutic Goods Advertising Code 2018
Australia: Proposed regulatory changes to personalised and 3D printed medical devices put on hold
Australia: Guidance on the regulatory requirements for in-house IVDs is updated
China: Proposals to relax certain requirements for renewals, clinical trial applications and Ethics Committee approvals
China: Significant and wide ranging changes proposed to medical device regulations
China: Electronic Regulated Product Submission system proposed
Egypt: All medical devices to be registered from 1 September 2018
Hong Kong: Updates made to the ‘Guidance Notes for Listing of Importers of Medical Devices’
India: Draft guidelines on the Essential Principles for safety and performance of medical devices
India: Confirmation of effective date for IS/ISO 15197 affecting glucometer test strips
India: DTAB proposes amendments to Medical Devices Rules, 2017, including more notified medical devices
Kenya: Device standards expected to be adopted in September 2018
Korea (Republic of): MDITAC renamed as NIDS
Korea (Republic of): Adverse event reporting requirements to be strengthened under proposed changes
Korea (Republic of): Criteria set for medical devices using virtual or augmented reality technology
Korea (Republic of): Smart Healthcare Cybersecurity Guide issued by MSIT
Malaysia: Medical device registration requirements now fully enforced
Malaysia: Exemption from registration for export-only medical devices
Malaysia: Recognition and listing of institutes or laboratories capable of providing clinical evidence or performance evaluation data for conformity assessment
Malaysia: Control of orphaned, obsolete and discontinued medical devices
Philippines: New draft fee schedule for medical device licensing and registration
Saudi Arabia: Registration deadline for low-risk Class I devices extended
Saudi Arabia: Guidance updated on shipment clearance procedures
Saudi Arabia: Guidance on requirements for listing non-sterile, non-measuring, low-risk medical devices
Singapore: Legislative changes offer faster access to medical devices and improved clarity on regulatory controls
Singapore: Consultations held on nine medical device guidance documents
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