Indonesia’s Ministry of Health has announced that it has simplified registration for some Class A medical devices and Classes 1 & 2 of household health supplies (PKRT).
Medical Device Distribution Certificate (IDAK, previously called SDAK) holders can take advantage of this new simplified registration by applying for a Distribution Permit Notification (Izin Edar Notifikasi Alkes dan PKRT), rather than having to apply in full for a Marketing Authorization Number or NIE (Nomor Izin Edar).
The main advantages of this applying for a Distribution Permit Notification are a reduced list of documentation to be filed as well as a shorter turnaround time. Typically, full registrations for Class A medical devices in Indonesia can take up to 45 working days to be processed. Whereas the simplified route takes a maximum of 36 working days and if no additional supporting documentation is required, an application can be processed in just 16 days.
In terms of documentation, applications for a Distribution Permit do not need to submit test results of clinical trials, packaging specifications or validation testing results, amongst others, making it a simpler process overall.
However, please note that a Distribution Permit simplified notification is not open for all Class A medical devices. It is only applicable for the following products:
Class A medical devices:
- Arm sling
- Body waste receptacle
- Cane
- Cane, crutch and walker tips and pads
- Cold pack
- Crutch
- Dental floss
- Elastic bandage
- Flotation cushion
- Hernia support
- Hot or cold disposable pack
- Hot/cold water bottle
- Ice bag
- Limb orthosis
- Manual breast pump
- Manual toothbrush
- Mechanical wheelchair
- Mechanical walker
- Medical adhesive tape and adhesive bandage
- Medical disposable bedding
- Medical insole
- Moist heat pack
- Nipple shield
- Non-resorbable gauze/sponge for external use
- Ophthalmic eye shield
- OTC Denture cleanser
- Patient scale
- Protective garment for incontinence
- Scented or scented deodorized menstrual pad
- Stand-on patient scale
- Teething ring
- Therapeutic massager
- Truncal orthosis
- Unscented menstrual pad
Class 1 household health products:
- Tissue and cotton
Class 2 household health products:
- Laundry Preparation
- Cleaner
- Baby and mother care products
- Antiseptic and disinfectant
- Fragrance
Notification Permit validity duration and fees
Upon issue, the validity duration of the Distribution Permit will match the duration stated in the Letter of Authorization (LoA) provided by the manufacturer to the local authorized representative. The minimum period is two (2) years with a maximum set at five (5) years. The Letter of Authorization is just one of the documents which must be submitted in the Distribution Permit Notification application.
Any existing registrations for the above-listed Class A medical devices and Class 1 & 2 household health supplies remain valid until the validity expiration date. However, should there be any changes to the product that would require a change notification to be submitted, then a new registration using the simplified notification must be made. Likewise, any license renewals for these products must also apply for the new simplified Distribution Permit Notification going forward. The Indonesian Government’s fee for the Distribution Permit is the same as the full registration fee for Class A medical devices, which is IDR 1,500,000, or around USD 105.00. The fee for Household Health Products (PKRT) depends on the class: Class 1 PKRT is IDR 1,000,000 (US$70) where are Class 2 is IDR 2,000,000 (US$140).
To learn more about registering medical devices in Indonesia click here.
To learn more about the Indonesian medical device market click here.
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