As the second-largest country in Latin America, with a population exceeding 125 million and major urban centers in Mexico City, Monterrey, and Guadalajara, Mexico represents a significant market for medical devices, with approximately 80% of devices imported. This import reliance highlights the substantial opportunities for foreign medical device manufacturers seeking Mexico medical device registration.
Malaysia’s Medical Device (Amendment) Regulations 2025 [P.U.(A) 330] raise Class A medical device application fees from RM 100 to RM 500 and add a RM 750 registration fee effective 1 January 2026. Manufacturers must submit before 10 December 2025 to keep the current rate. The change supports MDA’s cost-recovery model and strengthens post-market surveillance in Malaysia’s device sector.
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