Regulasi Pelabelan Perangkat Medis Meksiko: Panduan NOM-137-SSA1-2024

EPISODE · Nov 9, 2025 · 3 MIN

Regulasi Pelabelan Perangkat Medis Meksiko: Panduan NOM-137-SSA1-2024

from Akses Pasar Global Alat Kesehatan

Episode ini membahas secara mendalam standar pelabelan perangkat medis baru di Meksiko, NOM-137-SSA1-2024, yang akan berlaku pada 23 September 2024. Kami menguraikan persyaratan utama, termasuk kewajiban penggunaan bahasa Spanyol, definisi baru untuk pelabelan elektronik dan Software as a Medical Device (SaMD), serta dampak signifikan pembaruan ini bagi produsen yang ingin memasuki atau mempertahankan pasar Meksiko. - Kapan NOM-137-SSA1-2024 mulai berlaku secara efektif? - Apa saja perubahan paling signifikan dari standar pelabelan sebelumnya? - Apakah semua label perangkat medis untuk pasar Meksiko wajib menggunakan bahasa Spanyol? - Bagaimana standar baru ini mengatur pelabelan elektronik (e-labeling)? - Apa implikasi dari definisi Software as a Medical Device (SaMD) yang baru? - Informasi apa yang wajib dicantumkan pada label untuk memastikan kepatuhan? - Bagaimana pembaruan ini memengaruhi produsen perangkat medis internasional? Pure Global menawarkan solusi konsultasi peraturan ujung-ke-ujung untuk perusahaan Teknologi Medis (MedTech) dan Diagnostik In-Vitro (IVD). Dengan menggabungkan keahlian lokal dengan AI canggih dan alat data, kami menyederhanakan akses pasar global. Kami membantu Anda mengembangkan strategi peraturan yang efisien, menyusun dokumen teknis, dan bertindak sebagai perwakilan lokal Anda di lebih dari 30 pasar. Baik Anda sebuah startup atau perusahaan multinasional, teknologi kami memastikan kepatuhan yang berkelanjutan dan mempercepat waktu Anda untuk mencapai pasar. Hubungi kami di [email protected] atau kunjungi https://pureglobal.com. Jelajahi alat AI dan database gratis kami di https://pureglobal.ai.

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