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
- 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
- Nonresorbable 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
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.