Permenkes 11/2025 is now fully in effect

After a transition period, Permenkes 11/2025 is now fully in effect for all medical device businesses in Indonesia. We are still finding long-time clients whose internal processes have not caught up, and this guide is meant to help close that gap.

What Permenkes 11/2025 covers

Broadly, this regulation strengthens several areas that were previously loosely enforced in practice, particularly around post-market surveillance and clarity of license holder responsibility.

Five key changes businesses need to know

1. Sharper post-market surveillance enforcement
   Post-market surveillance is now treated as an active obligation rather than an annual formality. Companies are expected to run ongoing monitoring, not assemble a report close to the deadline.
2. More detailed documentation requirements
   For certain risk classes, the documentation required at registration and renewal is more detailed than under the previous rules.
3. Adjusted authority for Local Authorized Representatives
   Some types of reporting previously fully delegable to a LAR now have clearer authority limits, affecting how foreign manufacturers coordinate with their local partners.
4. A clearer link between CDAKB and license holder obligations
   The regulation reaffirms that holding CDAKB certification and carrying Izin Edar holder responsibility are interconnected, especially for entities playing a dual role.
5. The transition period has ended
   Companies still operating under the old rules are now at risk of non-compliance, since the transition window has closed.

Who is most affected

The companies that most need to review their internal processes are manufacturers with Class C and D products, entities acting as both license holder and distributor, and companies whose post-market reporting systems are still manual or unscheduled.

Steps we recommend

1. Review your current post-market surveillance process end to end;
2. Check whether registration documentation meets the latest standard;
3. Re-clarify reporting authority with your LAR, if applicable;
4. Make sure CDAKB certification and Izin Edar status stay aligned, not treated as two separate processes;

Conclusion

Permenkes 11/2025 does not change the basic principles of Indonesian medical device regulation, but it sharpens and tightens how they are enforced. Companies that skip reviewing their internal processes risk discovering the gap during an audit or license renewal, a far more expensive moment to fix it.

If your company has not done this review yet, we can help. Reach us at info@derayglobalutama.com.