ANNOUNCEMENT

Based on Permenkes 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector and with the issuance of a notification letter numbered UM.01.05/5/0024/2022 regarding the Enforcement of the Circular Permit of Notification of Medical Devices and PKRT which has been in effect since 10 January 2022. So we inform you of several things that need to be considered in fulfilling the requirements for the distribution permit for notifications:

• Currently submitting a new application for a distribution permit for class 1 and 2 PKRT notifications is carried out through the OSS RBA application (using the OSS RBA user ID and password via the link: http://oss.go.idwhile for the application for extension, change, extension with changes through the Regalkes application (using the regalkes user ID and password, via the link: http://regalkes.kemkes.go.id/

• he pre-market requirements for the distribution permit of class 1 and 2 HouseHold notifications are in the form of administrative documents and formulas, while technical documents must be completed in the Product Conformity Document (DKP) electronically and also stored and mandatory

• Changes that must be registered as a new application for a notification distribution permit, namely:
  a. Product name change
  b. Importer change
  c. Change of factory/manufacturer
  d. Change factory/manufacturer address
  e. Specification changes
  f. Change of raw material/formula
  g. Changes in company ownership, such as mergers or acquisitions[/list]

• In the event that the changes that can be submitted to the notification distribution permit are not related to DKP, namely:
  a. Changing the factory name does not change the address
  b. Principal name change
  c. Changes in packaging size
  d. Changes in packaging containers In addition to the changes above, there is no need to apply for notification changes.

• With the validity of the distribution permit for class 1 and 2 HouseHold notifications, the following certificate does not need to be submitted for a certificate related to marking, namely:
  a. Change notification letter
  b. Certificate of inclusion of halal logo
  c. Promotion certificate
  (unless combining several products that have different NIE in the form of bundling)

• Each statement on the Regalkes website must include a valid Rp. 10,000,- which does not violate CHAPTER IX of the criminal provisions of Law no. 10 of 2020 concerning Stamp Duty.

• Thus this notification is conveyed, please pay attention to all parties. Thank you

Source :http://regalkes.kemkes.go.id/index.php