ILHAM HIDAYATTULAH

“The process is still new but the Notification process is expected to expand to additional product categories to simplify the process and increase market access.”

Ilham Hidayattulah
Principal Consultant
Asia Actual Indonesia

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Indonesia to Permit Some Class A Products to Register via Notification

Published on: January 17th, 2022

Creates a New Registration Path for Low Risk Medical Devices

On January 10, 2022, Indonesia’s Ministry of Health released Indonesia Class A Notification Announcement 01.05500242022 establishing a new registration route for some low risk medical devices effective immediately. These product categories are exempt from the AKL licensing process and requires license holders apply for Notifications through the online registration system found here. Approval time is expected to be between 6 and 14 working days and will need to be renewed every 2-5 years. From Asia Actual’s experience, Class A medical device AKL applications are reviewed in under 15 working days and sometimes as quickly as 8 days. To learn more about the registration process in Indonesia, please click here.

Documents Required for Notification

At this time, only a select number of low risk medical devices are eligible for the new Notification process. The new process reduces the number of documents required as part of the application but does require 1 document be translated and 1 document legalized.

Documents required:

  1. Letter of Authorization
  2. Free Sale Certificate or equivalent
  3. ISO 13485, CE cert.
  4. Declaration of Conformity
  5. Raw materials used
  6. Final product specification / brochure
  7. Labeling
  8. Instructions For Use
  9. List of accessories / variant sizes / variant volumes

Registration Timelines

Compared to other markets in the region, Indonesia has an efficient registration process with all classifications of products being reviewed in under 60 days. Asia Actual has been tracking our clients’ experience and have included our experienced ranges below as well as the official response time. Official review times do not include additional time needed should the MOH have questions. Low risk medical devices are typically approved within 2-3 weeks while Class C and D can require up to 7-8 weeks with questions.

ClassificationOfficial Review Time (Working Days)Asia Actual’s Experience (Working Days)Government Fee
Class A Medical Device or IVD Device15 days8-15 daysUS$115 (Indonesia Rupiah 1,500,000)
Class B Medical Device or IVD Device30 days15-30 daysUS$230 (Indonesian Rupiah 3,000,000)
Class C Medical Device or IVD Device30 days15-30 daysUS$230 (Indonesian Rupiah 3,000,000)
Class D Medical Device or IVD Device45 days17-40 daysUS$340 (Indonesian Rupiah 5,000,000)

Low Risk Medical Devices Permitted to be Registered by Notification

At this time, only a subset of Class A (low risk) medical devices are permitted to go through the Notification process.

  1. Arm slings
  2. Body waste receptacles
  3. Canes
  4. Cane, crutch, and walker tips and pads.
  5. Cold packs.
  6. Crutches
  7. Dental floss
  8. Elastic bandages
  9. Flotation cushions
  10. Hernia support
  11. Hot or cold disposable packs
  12. Hot/cold water bottles
  13. Ice bags
  14. Limb orthosis
  15. Manual breast pumps
  16. Manual toothbrushes
  17. Mechanical wheelchairs
  18. Mechanical walkers
  19. Medical adhesive tape and adhesive bandage (NON STERILE)
  20. Medical disposable bedding
  21. Medical insoles
  22. Moist heat packs.
  23. Nipple shields
  24. Non-resorbable gauze/sponge for external use (NON STERILE)
  25. Ophthalmic eye shields
  26. OTC Denture cleansers
  27. Patient scales
  28. Protective garments for incontinence
  29. Scented or scented deodorized menstrual pads
  30. Stand-on patient scales
  31. Teething rings
  32. Therapeutic massagers
  33. Truncal orthosis
  34. Unscented menstrual pads

Come Grow With Us

Asia Actual has offices staffed by experienced, bilingual regulatory and commercial professionals in the major capital cities of Asia including Jakarta.  Contact Asia Actual to see how these changes may impact your business in Indonesia and to stay abreast of this dynamic situation.

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