ANNOUNCEMENT

In accordance with Permenkes 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector, and following the issuance of notification letter number UM.01.05/5/0024/2022 regarding the enforcement of the Circular Permit of Notification for Medical Devices and Household Chemical Substances (PKRT), which has been in effect since January 10, 2022, we would like to inform you about several important considerations for fulfilling the requirements for the distribution permit for notifications.

Currently, new applications for a distribution permit for Class 1 and Class 2 PKRT notifications must be submitted through the OSS RBA application. This can be done using your OSS RBA user ID and password at the following link: http://oss.go.id. For applications concerning extensions, changes, or extensions with changes, please use the Regalkes application with your Regalkes user ID and password at http://regalkes.kemkes.go.id.

The pre-market requirements for distribution permits for Class 1 and Class 2 Household notifications include both administrative documents and product formulas. Additionally, technical documents must be completed in the Product Conformity Document (DKP) electronically and must be stored as required.

Changes that necessitate the registration of a new application for a notification distribution permit include:

• Change of product name
• Change of importer
• Change of factory/manufacturer
• Change of factory/manufacturer address
• Specification changes
• Change of raw material/formula
• Changes in company ownership, such as mergers or acquisitions

Certain changes do not require a new application for the notification distribution permit, including:

• Change of factory name (without changing the address)
• Change of principal name
• Changes in packaging size
• Changes in packaging containers

For the validity of distribution permits for Class 1 and Class 2 Household notifications, the following certificates do not need to be submitted regarding marking:

• Change notification letter
• Certificate of inclusion of halal logo
• Promotion certificate (unless combining several products with different NIEs in the form of bundling)

Each statement submitted on the Regalkes website must include a valid payment of Rp. 10,000, in compliance with Chapter IX of the criminal provisions of Law No. 10 of 2020 concerning Stamp Duty.

We hope this notification is clear and informative. Please pay attention to all parties involved. Thank you.

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