Pure Global Editorial Team

Brazil's ANVISA and the Hong Kong Department of Health signed a five-year Memorandum of Understanding on 23 September 2026 for cooperation and information exchange, including on medical devices. The MoU is expressly non-binding and does not change device registration in Brazil or listing in Hong Kong.

Indonesia's Minister of Health issued KMK 951/2026 on 7 September 2026, a marketing authorization guideline for software as a medical device, software in a medical device and AI-enabled devices. It sets AI/ML dossier content, local clinical validation for certain imported software, a new-authorization rule for changes affecting indication for use, main function or clinical performance, and annual routine inspections.

In a 17 September 2026 press release, Singapore's HSA reported MOUs with the Saudi Food and Drug Authority and the African Medicines Agency, a Malaysian NPRA pilot referencing HSA's medicine assessments, continued work with the UK MHRA and its IMDRF chair deliverables. The release announces no change to device registration requirements and no reliance route open to device manufacturers.

On 25 September 2026 WHO launched medical device prequalification assessments. Condom and IUD prequalification moves from UNFPA to WHO, CAD-TB screening software becomes eligible, and WHO may remove UNFPA-prequalified contraceptives from its acknowledgment list if their manufacturers have not applied by 30 September 2028.

NMPA’s final inspection principles set 200 graded items and distinguish licensing failure from post-market production suspension. From 1 November 2026, specific pending applications and uninspected Class I filings move to the revised GMP; existing specialised annexes also remain applicable.

FDA has finalised manufacturer guidance for blood collection, processing and storage systems used with the buffy coat method. The nonbinding recommendations address pathway selection, separation timing, materials and solutions, and the evidence supporting the proposed system.

HSA GN-15 Revision 14 requires an Annex 4 declaration across the listed Class B/C/D registration routes, including Full evaluation. The guidance also sets out current Priority Review focus areas and the safety criterion for Class C standalone medical mobile applications.

The COMBINE Project 2 guide explains safety reporting for studies spanning multiple EU regulatory frameworks. It recommends a 7-calendar-day device reporting timeline, while preserving statutory CTR notifications, national requirements and separate sponsor responsibilities.

Korea’s final MFDS Notice 2026-63 adds the overseas-use criteria and two evidence categories for certain post-market study exemption requests. It implements the existing eligibility framework, including orphan devices, while retaining committee review and other safety duties.

MDCG 2020-16 revision 5 clarifies the boundary between indicative values for standalone QC materials and manufacturer-assigned values. It also explains the IFU limitation for laboratory-monitoring materials. The guidance leaves the legal classification rules in place and sets no transition deadline.

Taiwan amended Articles 4 and 14 of its recall regulations for imported devices with specified domestic Chinese-labelling violations. Eligibility depends on Article 22 compliance, suitability for rework and authority supervision. Publication on 10 September leads to legal effect on 12 September under the statutory counting rule.

From 1 October 2026, Taiwan will trial retained originals for electronic submissions and electronic approved labelling. The scope differs between the two measures, and electronic amendment and extension approvals still require the original licence to be sent for endorsement.

ANVISA clarifies recognized-standard evidence, voluntary use, and manufacturer responsibility. Its current linked list covers orthopedic implant materials.

Australia’s F2026L01167 adds clause 2.2A for specified non-invasive, saline-only flush and patency devices from 8 September 2026. Kinds included because of earlier applications have a five-year transition. From 1 November 2026, the CDSS exemption has five statutory limbs. Compare the amended wording, application dates and unchanged exemption conditions.

NMPA Announcement No. 107 of 2025 replaces the 2014 medical device GMP on 1 November 2026. The revised text has 15 chapters and 132 articles, including three added chapters and separate production and market release responsibilities. The text does not specify any additional grace period after that date. Hubei and Hunan have preparation schedules.

Hong Kong revised GN-01, GN-04, GN-07, GN-08 and GN-09 and five Codes of Practice, effective 1 September 2026. The package addresses certificate verification, conditional approvals and local-manufacturer inspections. GN-08 states five-year listing validity, but COP-03 contains conflicting renewal wording that manufacturers should clarify with MDD.

MFDS Notice No. 2026-54 clarifies clinical-evidence exemptions and replacements for specified software functions without clinical-effectiveness claims. It also extends certified manufacturers’ special treatment to ungraded standalone software and allows real-world evaluation within a period of up to three years, subject to reporting and further review.

Circular 24/2026/TT-BYT, effective 1 July 2026, amends Circular 05/2022 and repeals Circular 59/2025. It moves the purchase-date cutoff for six device categories to 1 July 2027; devices purchased earlier must complete safety and technical-performance inspection before 1 January 2028. Classification remains under Decree 98/2021 and its implementing documents.