On 9 January 2018, Minister of Health of the Republic of Indonesia has enacted the Regulation of Minister of Health No. 60 Year 2017 regarding supervision of import order of imported medical devices, in vitro medical devices and household health supplies (“RMH No.60/2017”). This regulation was enacted in order to ensure the certainty of its implementation and to improve the effectiveness of supervision on imported medical devices, in vitro diagnostic health equipment and household health supplies.
Distributors of medical devices and importers who import medical devices, in vitro diagnostic medical devices and household health supplies ("HHS") submit the notification of import customs which research is conducted by Indonesia National Single Window ("INSW") portal and/or Customs and Excise Officials. The result of the research is notified to the General Director by the Manager of INSW Portal and/or Customs and Excise Officer.
Medical Devices, in vitro diagnostic medical devices and imported HHS are supervised by the Minister inside customs area and outside customs area which are stipulated by the Minister. The Minister may grant delegation of authority to the General Director.
The supervision of medical devices, in vitro diagnostic medical devices and imported HHS by the General Director shall be based on risk management, through
the analysis and evaluation:
- notification from INSW portal or Customs Officer
- compliance with licensing
or, through inspection:
- Inspection of distribution facilities and products; and
- Special inspection of means on distribution and products.
For distribution license of medical devices, in vitro diagnostic medical devices and HHS are stipulated under Regulation of Minister of Health No. 62 Year 2017 (“RMH No.62/2017”).
The procedure of applying a new distribution license of medical devices, in vitro diagnostic medical devices and HHS can be made through INSW portal or through regalkes.kemkes.go.id and completed by the administrative requirements as described in annex which serves as an integral part of this ministerial regulation.
The General Director will assess and verify the administrative requirements regarding each of the applications of distribution license of medical devices, in vitro diagnostic medical devices and HHS.
The validity period of distribution license is five years. If the distribution license’s holder would like to do an extension of the license, then the holder must submit the application no later than nine months before the expiry date.
The destruction of medical devices, in vitro diagnostic medical devices and HHS can be performed, if:
- It does not fulfill the safety and quality requirements to be use
- It is expired
- Its distribution license is revoked;
- It is manufactured and/or imported not according to the applicable law; or
- related to the criminal
Violation of the provision under RMH No.62/2017 may be subject to an administrative sanction which are a written notice, temporary suspension of the activities, and revocation of the distribution license.