An update from the Ministry of Health of the Republic of Indonesia states that all medical device companies that hold a Good Distribution Practice for Medical Devices (GDMPD) certificate are required to submit their internal audit reports to the Ministry of Health once a year.

This requirement refers to the new regulation, Government Regulation (PP) No. 28 of 2025 concerning Risk-Based Business Licensing Implementation, specifically Article 238, Paragraph 3, which outlines the supervision and inspection of business operator reports.

This regulation will come into effect in September 2025. Internal audit reports can be submitted via email to audit.cdakb@gmail.com. Companies are only required to submit proof or a summary (resume) of the internal audit implementation to fulfill this obligation.

Companies that fail to submit their annual internal audit reports may face serious sanctions from the Ministry of Health, including:

• Revocation of Distribution Permit Number (NIE)
• Withdrawal of the CDAKB Certificate
• Closure of access to PB UMKU licensing applications via OSS RBA

With the introduction of this new regulation, it is expected that all medical device business operators will become more proactive and compliant in fulfilling their internal audit obligations, as part of a more transparent and accountable supervision system for medical device distribution.

Source :

Surat Pemberitahuan Penyampaian Laporan Hasil Audit Internal oleh Distributor Alkes