Pure Global Editorial Team

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.

Argentina's Disposición ANMAT Nº 5461/2026 adds an ARS 5,000,000 ceiling to the 1.25% medical-product import-intervention fee from 1 September 2026. The ARS 55,000,000 tier threshold, both percentage rates, and the fixed device and IVD fees in Anexo II are numerically unchanged from the May 2026 schedule.

The Medical Devices (Third Amendment) Rules, 2026 add “or European Union countries” to Rule 63(1) proviso (iv) for devices without a predicate. The two-year marketing, CLA, and post-marketing-investigation conditions are unchanged. Class A NSNM manufacturers and importers must now self-certify compliance with the Quality Management System as well as standards specified in the rules.

The Medical Devices (Second Amendment) Rules, 2026 add Rule 44(p): when sterilisation is outsourced to another licensed facility, that site’s licence number must appear on the device label. Compliance is mandatory six months from 14 August 2026 (14 February 2027). A Ninth Schedule of test fees applies from gazette publication.

Dated 28 July 2026, FDA Advisory No. 2026-1007 clarifies that a medical-device CPR remains valid after its expiry date if renewal was filed within 120 days of original expiry and applicable fees were paid, but only until FDA decides the application. It does not amend the IRR of RA 9711.