Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong
US: +1 512 898-9222
SG: +65 8800-3197
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.
- Letter of Authorization
- Free Sale Certificate or equivalent
- ISO 13485, CE cert.
- Declaration of Conformity
- Raw materials used
- Final product specification / brochure
- Instructions For Use
- List of accessories / variant sizes / variant volumes
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.
|Classification||Official Review Time (Working Days)||Asia Actual’s Experience (Working Days)||Government Fee|
|Class A Medical Device or IVD Device||15 days||8-15 days||US$115 (Indonesia Rupiah 1,500,000)|
|Class B Medical Device or IVD Device||30 days||15-30 days||US$230 (Indonesian Rupiah 3,000,000)|
|Class C Medical Device or IVD Device||30 days||15-30 days||US$230 (Indonesian Rupiah 3,000,000)|
|Class D Medical Device or IVD Device||45 days||17-40 days||US$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.
- Arm slings
- Body waste receptacles
- Cane, crutch, and walker tips and pads.
- Cold packs.
- Dental floss
- Elastic bandages
- Flotation cushions
- Hernia support
- Hot or cold disposable packs
- Hot/cold water bottles
- Ice bags
- Limb orthosis
- Manual breast pumps
- Manual toothbrushes
- Mechanical wheelchairs
- Mechanical walkers
- Medical adhesive tape and adhesive bandage (NON STERILE)
- Medical disposable bedding
- Medical insoles
- Moist heat packs.
- Nipple shields
- Non-resorbable gauze/sponge for external use (NON STERILE)
- Ophthalmic eye shields
- OTC Denture cleansers
- Patient scales
- Protective garments for incontinence
- Scented or scented deodorized menstrual pads
- Stand-on patient scales
- Teething rings
- Therapeutic massagers
- Truncal orthosis
- 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.