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Hong Kong MDD’s GN-02 and GN-06 2026 (Ed. 1.0) listing notes are effective 31 July 2026. Applications already in MDIS are unaffected. The in-force texts cover Novo Lane, the default Expedited Approval Scheme, Hospital Authority purchase-order fields, and translation evidence.

Hong Kong MDD issued GN-10:2026(E) Edition 3, effective 26 June 2026. The change-management notes add clause 5.3: eighteen listed-device changes that do not require reporting, unless they follow a safety alert or could affect safety, quality, or performance. Major Changes still need approval before implementation.

ANVISA now requires Class I and II foreign manufacturer record requests, including IVDs, to use Solicita subject 80326. The record generates the unique international-manufacturer code required in imported-product filings; Class III and IV remain CBPF-linked.

HSA’s GN-21 Revision 7, labelled Revision 6.1 and effective 1 August 2026, ends implement-on-acknowledgement for 6Aii and 6Aiii public SMDR listing changes. Those changes now need HSA approval before implementation in Singapore. Annex 2 also caps each listing at two active change-notification applications, with full rejection and no fee refund if a third is filed.

Pure Global has launched a flat-fee pricing model for medical device registration that simplifies global expansion across 13 key markets. With AI-assisted dossier preparation and in-country representation included, manufacturers can easily plan their market access budgets.

Pure Global has launched AI Builder, a proprietary automation platform that cuts medical device dossier preparation time by up to 75%. The launch introduces a new flat annual pricing model and marks a major step toward on-demand, AI-powered global medical device registration.

Pure Global's new CTO, Ran Chen, brings over a decade of experience in building and scaling machine learning products.

Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website.