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Malaysia MDA Medical Device Registration: 24 Questions on AR, CAB and MeDC@St, Plus the Singapore-Malaysia-Thailand Regulatory Reliance Mechanism

Regulatory Info

Malaysia MDA Medical Device Registration: 24 Questions on AR, CAB and MeDC@St, Plus the Singapore-Malaysia-Thailand Regulatory Reliance Mechanism

Malaysia is the second largest medical device market in ASEAN, and a market that Chinese companies cannot bypass when expanding into Southeast Asia. O…

Thai FDA Recognises the Malaysian Medical Device Authority Malaysia Added as the Eighth Recognised Foreign Agency Under the Regulatory Reliance Programme

Regulatory Info

Thai FDA Recognises the Malaysian Medical Device Authority Malaysia Added as the Eighth Recognised Foreign Agency Under the Regulatory Reliance Programme

On 6 October 2026, the Thai Food and Drug Administration (Thai FDA) published "Announcement on the List of Foreign Agencies Recognised by the Thai FDA…

Singapore HSA Implements GN-15 Revision 15 and Issues Premarket Submission Checklist MD-01 R1

Regulatory Info

Singapore HSA Implements GN-15 Revision 15 and Issues Premarket Submission Checklist MD-01 R1

On 1 October 2026, the Health Sciences Authority (HSA) of Singapore implemented the "Guidance on Medical Device Product Registration" (GN-15, Revision…

Tanzania Medicines & Medical Devices Authority Joins MDSAP TMDA Accepted as an Affiliate Member of the Medical Device Single Audit Program

Regulatory Info

Tanzania Medicines & Medical Devices Authority Joins MDSAP TMDA Accepted as an Affiliate Member of the Medical Device Single Audit Program

On 16 September 2026, the MDSAP website published a notice that on 13 September 2026 the MDSAP Regulatory Authority Council (RAC) had unanimously agre…

Russia Approves New Administrative Regulation for State Registration of Medical Devices: Order No. 750

Regulatory Info

Russia Approves New Administrative Regulation for State Registration of Medical Devices: Order No. 750

The Federal Service for Supervision in Healthcare (Roszdravnadzor) has issued Order No. 750 approving a new Administrative Regulation of the Federal S…

Australia UDI Compliance Timeframes for Medical Devices: TGA Version 2.1 Sets Out Implementation Dates, Transition Arrangements and Responsibilities

Regulatory Info

Australia UDI Compliance Timeframes for Medical Devices: TGA Version 2.1 Sets Out Implementation Dates, Transition Arrangements and Responsibilities

The Therapeutic Goods Administration (TGA) has published Version 2.1 of "Complying with the Unique Device Identification timeframes for medical device…

Thai FDA Expands Listed Technical Documentation Reviewers: Three Additional Experts and One NSTDA Testing Institution

Regulatory Info

Thai FDA Expands Listed Technical Documentation Reviewers: Three Additional Experts and One NSTDA Testing Institution

On 17 September 2026, the Thai Food and Drug Administration (Thai FDA) published Announcement No. 23 (B.E. 2569), further expanding the list of expert…

Hong Kong Requires MDACS Listing for Injectable and Infusable Products Used in Licensed Private Healthcare Facilities

Regulatory Info

Hong Kong Requires MDACS Listing for Injectable and Infusable Products Used in Licensed Private Healthcare Facilities

On 9 September 2026, the Office of Regulation of Private Healthcare Facilities (ORPHF) of the Department of Health issued a letter updating the regula…

FDA Updates Small Business Determination Program: FY 2027 Application Windows, Fee Reductions and CDRH Portal Submission

Regulatory Info

FDA Updates Small Business Determination Program: FY 2027 Application Windows, Fee Reductions and CDRH Portal Submission

On 10 September 2026, the U.S. Food and Drug Administration (FDA) updated the Small Business Determination (SBD) program for medical devices. The upda…

Thailand Device Registration: When a Technical Review Fee Applies to Class 2–4 Devices

Regulatory Info

Thailand Device Registration: When a Technical Review Fee Applies to Class 2–4 Devices

During medical device registration in Thailand, whether a Class 2 to Class 4 device attracts a technical review fee depends on the technical documenta…

EU IVD Classification Guidance Rule 7 Updated: MDCG 2020-16 rev.5 Clarifies Criteria for Unassigned Quality Control Materials

Regulatory Info

EU IVD Classification Guidance Rule 7 Updated: MDCG 2020-16 rev.5 Clarifies Criteria for Unassigned Quality Control Materials

On 9 September 2026, the Medical Device Coordination Group (MDCG) published MDCG 2020-16 rev.5 — "Guidance on Classification Rules for in Vitro Diagno…

TGA Updates Classification Rules: Saline Flushes and Device Locking Solutions Explicitly Classified as Class IIa

Regulatory Info

TGA Updates Classification Rules: Saline Flushes and Device Locking Solutions Explicitly Classified as Class IIa

On 8 September 2026, the Australian Therapeutic Goods Administration (TGA) published updates to the classification rules for certain combination produ…

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