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

FDA’s 2025 user fee guidance updates small business fee waiver rules, detailing financial hardship criteria and replacing Forms 3602/3602A with Form 3602N. It supports small medical device companies by clarifying eligible documentation, including for entities in tax-exempt jurisdictions, to ease FDA registration costs and encourage market entry.

The EU Notified Bodies Survey 2025 highlights rising MDR and IVDR certification activities but also ongoing challenges with capacity and documentation. Manufacturers should proactively plan their certification strategies to ensure timely compliance and market access across the European Union.

Mexico’s COFEPRIS has introduced a new Abbreviated Regulatory Pathway, effective September 1, 2025, allowing medical device manufacturers to leverage prior approvals from IMDRF or MDSAP member authorities. This fast-track route reduces documentation requirements and mandates a 30-day decision timeline, aligning Mexico’s regulatory framework more closely with international standards.

Malaysia’s Medical Device Authority (MDA) and China’s NMPA have launched the Pilot Phase I of their 2025 Regulatory Reliance Programme, enabling expedited market access for in-vitro diagnostic (IVD) devices. Running from 30 July to 30 September 2025, this bilateral initiative allows qualified manufacturers in both countries to streamline approvals under mutual recognition.

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.

Unlock efficient market access with Pure Global & MEDIcept's collaboration. From registration to regulatory expertise, we offer comprehensive solutions worldwide. Drive growth & innovation in MedTech.

Malaysia, a key gateway to Southeast Asia, offers strategic access for businesses. Understanding medical device regulations is crucial for market entry.