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.

In 2026, Anvisa joined Brazil’s government mission to China to strengthen cooperation on health products, including medicines, medical devices, and blood products. The mission focuses on regulatory alignment, technology transfer, and sharing of technical knowledge. Director Daniela Marreco officially represents Anvisa, engaging with Chinese authorities, companies, and smart hospitals. This collaboration aims to streamline product registration while maintaining safety and quality, enabling faster access to advanced medical technologies in Brazil.

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.

Vietnam’s Decree 37/2026/ND-CP updates medical device labeling, effective from January 26, 2026, specifying circulation numbers, lot numbers, dates, warnings, instructions, and supplementary labels for foreign-language imports. Existing products manufactured or imported before this date do not need to comply.

Brazil’s 2026 Anvisa–MFDS Cosmetics MoU strengthens regulatory cooperation between Brazil and South Korea. The agreement focuses on cosmetics regulation, safety assessment, post-market surveillance, and regulatory alignment. By enhancing technical exchange and harmonization efforts, the partnership supports smoother market access and stronger public health oversight. The MoU updates a 2014 agreement and reflects growing global convergence in cosmetics regulatory frameworks.

Malaysia MDA’s 2026 revised labelling guidelines introduce e-labelling for home-use medical devices, allowing electronic delivery of instructions and safety information. E-labelling must include all required label content, be accessible via URL or QR code, and undergo a risk assessment to ensure safety. Printed labels may still be required for critical information. This update improves accessibility, reduces printing costs, and reflects Malaysia’s commitment to modern, patient-friendly medical device regulation.

Malaysia’s 2026 MDA–HSA Regulatory Reliance update formally recognizes Singapore’s HSA as a reference authority after a six-month pilot. Devices registered with HSA may qualify for conformity assessment in Malaysia via verification, benefiting from lower CAB fees and shorter review timelines. The programme strengthens ASEAN regulatory convergence and supports faster Malaysia medical device registration while maintaining compliance and safety standards.

ANVISA Normative Instruction 426/2026 defines how UDI data must be transmitted and managed in Brazil’s SIUD database under RDC 591/2021. It establishes initial transmission rules, correction timelines, third-party authorization, and discontinuation procedures. Normative Instruction 426/2026 goes into effect March 1, 2026.