Indonesia simplifies registration for some Class A medical devices

Indonesia simplifies registration for some Class A medical devices

The Ministry of Health in Indonesia is simplifying the registration process for 34 Class A medical devices as well as some Class I and II Household Health supplies (Perbekalan Kesehatan Rumah Tangga or PKRT).

The new process will require SDAK (Sertifikat Distribusi Alat Kesehatan) or Medical Device Distribution Certificate (MDDC) holders to obtain Distribution Permit Notifications rather than registering these medical devices or household health supply products in full.

Certain class A medical devices are home-use medical devices that can be used independently without requiring special skills or a professionally trained health worker, they are not sterile medical devices and are not In Vitro Diagnostic medical devices.

List of Class A medical devices eligible for simplified Distribution Permit Notification route


  1. Arm sling
  2. Body waste receptacle
  3. Cane
  4. Cane, crutch and walker tips and pads
  5. Cold pack
  6. Crutch
  7. Dental floss
  8. Elastic bandage
  9. Flotation cushion
  10. Hernia support
  11. Hot or cold disposable pack
  12. Hot/cold water bottle
  13. Ice bag
  14. Limb orthosis
  15. Manual breast pump
  16. Manual toothbrush
  17. Mechanical wheelchair
  18. Mechanical walker
  19. Medical adhesive tape and adhesive bandage
  20. Medical disposable bedding
  21. Medical insole
  22. Moist heat pack
  23. Nipple shield
  24. Nonresorbable gauze/sponge for external use
  25. Ophthalmic eye shield
  26. OTC Denture cleanser
  27. Patient scale
  28. Protective garment for incontinence
  29. Scented or scented deodorized menstrual pad
  30. Stand-on patient scale
  31. Teething ring
  32. Therapeutic massager
  33. Truncal orthosis
  34. Unscented menstrual pad

At present the Online Registration platform, Kemenkes, is being updated to cater for this new Distribution Permit Notification. We will share an update once this route to market is available.

To learn more about registering medical devices in Indonesia click here.

We can register and import your medical device into Indonesia. Contact our sales team to find out more by clicking on the button below.

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