Connect and stay on top of the MedTech regulatory landscape globally.

Mexico has published the COFEPRIS Medical Device Registration Guidance 2026, providing the first comprehensive instructions for preparing registration dossiers under the Equivalence Agreements and Abbreviated Regulatory Pathway. The guidance clarifies expectations for administrative, quality, technical, clinical, and post-market surveillance documentation, with a strong emphasis on document consistency, manufacturing traceability, Spanish-language compliance, and risk-based evidence.

MDA's MeDC@St 2.0+ Automated Re-Registration Route allows eligible medical device registration holders to renew registrations through an automated process. Applications must be submitted within one year before expiry, as expired registrations require a new registration under the Medical Device Act 2012 (Act 737).

Malaysia's MDA and China's NMPA have launched Pilot Phase 2 of the Malaysia-China Joint Evaluation Pilot Programme, open from 1 July to 30 September 2026. The programme enables simultaneous evaluation of eligible medical devices under the GHWP CERP framework to reduce duplicative review and support faster access to both markets.

The Philippine Department of Health has extended the suspension of higher medical device registration fees for another 120 working days from 2 June 2026, keeping CMDR applications under the current lower government fee schedule while Administrative Order No. 2024-0016 remains suspended.

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.