This week in global device regulatory news, Malaysia’s MDA issued updated ASEAN guidance on borderline products and risk-based classifications, Mexico’s COFEPRIS proposed faster equivalency pathways that accept IMDRF- and MDSAP-member approvals, and Brazil’s Anvisa cancelled IVD devices that missed the RDC 830 reclassification cutoff.
The Medical Device Authority (MDA) of Malaysia issues an annually updated guidance (MDA/GD/0063) listing borderline products—items with characteristics that may classify them as either medical devices or non-medical products. Aligned with the ASEAN Medical Device Directive (AMDD), this document clarifies classifications based on manufacturer-intended use and supports consistent approval across ASEAN member states via the ASEAN Medical Device Committee (AMDC).
This guidance document (MDA/GD/0062) outlines the harmonised risk classification of medical devices—including in-vitro diagnostic (IVD) devices—across ASEAN member states under the ASEAN Medical Device Directive (AMDD). It aims to support manufacturers and authorized representatives in determining the appropriate class (A, B, C, or D) for their products based on intended use and associated risk. Aligned with Malaysia’s Medical Device Regulations 2012 and updated annually by the ASEAN Medical Device Committee (AMDC), this harmonised approach enhances regulatory consistency and facilitates smoother access to the ASEAN medical device market.
Learn more about MDA Malaysia Medical Device Classification.
Chapter IV of the Gazette introduces a proposed expansion of regulatory pathways for medical devices in Mexico. COFEPRIS aims to recognize approvals from IMDRF member countries and MDSAP authorities, creating potential new equivalency routes. Under this framework, applicants may demonstrate GMP compliance using internationally accepted certificates, including those issued by RRAs, MDSAP, ISO 13485, or CE markings. Specific homologation codes have been outlined for devices approved by the FDA, Health Canada, and Japan’s PMDA, with provisional codes under consideration for other RRAs. Additionally, COFEPRIS may be required to issue registration decisions for medical devices within 30 business days, signaling a move toward more efficient regulatory processing. Further guidance from COFEPRIS on these changes is expected.
Learn more about COFEPRIS Mexico Medical Device Regulations.
On Monday, June 9, 2025, Anvisa published the cancellation of in vitro diagnostic (IVD) medical devices that failed to comply with the health reclassification requirements set by RDC 830, issued on December 6, 2023. This resolution established updated criteria for the regularization of IVD products marketed in Brazil, including a revised risk classification system aligned with international regulatory practices. The new rules require manufacturers to submit reclassification petitions reflecting their products’ risk levels. With the deadline for this health reclassification now passed, Anvisa is cancelling notifications for all IVD devices that did not file the necessary petitions according to the updated classification framework, ensuring that only compliant and properly classified devices remain available in the Brazilian market.
Learn more about ANVISA Brazil Medical Device Classification.
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