25/06/2026
Permenkes 5/2026 memperkuat pengawasan alat kesehatan di Indonesia.
Fokusnya bukan menambah dokumen, tetapi memastikan sistem ISO 13485 benar-benar berjalan di lapangan.
Banyak organisasi sudah memiliki sistem yang baik di atas kertas, namun tantangan muncul saat diterapkan dalam kondisi nyata: supplier, distribusi, keluhan, hingga kompetensi.
Area yang paling sering menjadi perhatian adalah supplier control, traceability, complaint handling, CAPA, dan competence.
ISO 13485 bukan hanya tentang memiliki sistem mutu, tetapi tentang memastikan mutu, keamanan, dan ketertelusuran tetap terjaga sampai produk digunakan di pasar.
Yang dinilai bukan dokumen, tetapi bukti bahwa sistem bekerja.
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Permenkes 5/2026 strengthens the regulatory oversight of medical devices in Indonesia.
The focus is no longer on producing more documentation, but on ensuring that the ISO 13485 system is effectively implemented in practice.
Many organizations already have well-documented systems in place, yet challenges often emerge in real-world execution—across suppliers, distribution, complaints, and personnel competence.
The most frequently scrutinized areas in audits and compliance assessments include supplier control, traceability, complaint handling, CAPA, and competence.
ISO 13485 is not merely about having a quality management system. It is about ensuring that quality, safety, and traceability are consistently maintained throughout the entire lifecycle of a medical device.
Ultimately, what is evaluated is not the documentation itself, but the evidence that the system is truly functioning in practice..