Path of Registration
Register Medical or Household Equipments Products in Indonesia
Registration of medical equipments is strictly ruled in Indonesia. The manufacturer and distributor must propose license application of medical equipments before the products being imported, sold or used in Indonesia’s territory.
Medical equipments also ruled by Kemenkes. There are categories of medical equipment based on risk. These categories will affect the period registration. Class I medical equipments (low risk, 30 working days), Class IIa and IIb (middle risk, 60 working days), Class III (high risk, 90 working days).
License for medical and household equipments valid for 5 years and can be renewed. If there is modification on size of the label or packaging then the license must be adjusted. The company must have an office or local distributor in Indonesia which already registered in Kemenkes. Those who are valid as applicants:
- Main manufacturer in Indonesia
- Local representatives or local distributor