Towards Safety and Quality: CPAKB Certificate Mandatory From January 1, 2024

In an effort to ensure the safety, quality, and efficacy of domestic medical devices, the Government of Indonesia has enacted Minister of Health Regulation No. 20 of 2017. This regulation mandates that companies producing medical devices or household health supplies implement Good Manufacturing Practices for Medical Devices (CPAKB) or Good Manufacturing Practices for Household Health Supplies (CPPKRTB).

According to Article 2 of this regulation, the implementation of CPAKB or CPPKRTB must be validated with an audit certificate issued in accordance with the stipulated guidelines. All industries involved in medical devices and household health supplies are required to comply with this regulation within four years of its promulgation, with a deadline set for January 1, 2024.

It is important to note that, starting from this date, the CPAKB certificate will be a mandatory requirement for applications for distribution licenses for domestic medical devices. As a transitional measure, applications for distribution licenses that are still undergoing the CPAKB certification process as of December 31, 2023, will be granted a one-year validity period. When renewing distribution licenses, companies must attach the CPAKB certificate corresponding to the registered product scope.

We recognize the significance of compliance with these regulations. For further information regarding the implementation of Minister of Health Regulation No. 20 of 2017 concerning CPAKB certification requirements, as well as Minister of Health Regulation No. 4 of 2014 concerning Good Distribution Practices for Medical Devices (CDAKB) and Minister of Health Regulation No. 14 of 2021 regarding Standards for Business Activities and Products in the Risk-Based Health Licensing Sector, please contact us.

Kami siap membantu dan memberikan panduan agar perusahaan Anda dapat memenuhi persyaratan ini tepat waktu, menjaga standar kualitas, serta meraih kepercayaan pelanggan. Memastikan keamanan dan kualitas alat kesehatan adalah investasi jangka panjang bagi kesejahteraan masyarakat.

Source : ANNOUNCEMENT NUMBER: FR.03.01/E/992/2023 Regarding the Implementation of CPAKB Certification as a Requirement for Distribution Licenses.