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

COFEPRIS electronic notifications 2026 allow regulated entities in Mexico to receive official communications via email, covering updates on procedures, administrative requirements, and final resolutions. Businesses must complete the official authorization form and maintain accurate email addresses. The system improves communication speed, traceability, and legal certainty, reducing administrative backlog and enhancing compliance reliability for industries such as pharmaceuticals, medical devices, food, and cosmetics.

COFEPRIS modifications guideline 2026 defines procedures, documentation, and responsibilities for medical device registration changes in Mexico. It covers administrative and technical modifications, including manufacturer, distributor, and product name updates. All documents must be valid, in Spanish or English, and compliant with GMP, Free Sale, and Analysis certificate standards. Certain changes affecting safety or intended use require a new registration.

Malaysia’s MDA has joined the WHO Collaborative Registration Procedure (CRP) for prequalified in vitro diagnostics, enabling accelerated national registration by leveraging WHO prequalification assessments. Applicants must submit products identical to the WHOprequalified version, provide manufacturer consent for report sharing, and comply with Malaysian regulatory requirements. MDA aims to complete reviews within 90 working days, reducing duplication and improving access to quality diagnostics.

Thailand’s FDA introduced a 2026 electronic change notification system for medical devices, enabling license holders to submit post-approval amendments digitally. The platform supports updates such as labeling changes, manufacturer details, and device item lists. The system aims to streamline submissions, reduce paperwork, and improve tracking of regulatory updates for companies managing Thailand medical device registrations.

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.