Law Number 36 Year 2009 on Health mandates that all medical devices circulating in Indonesia must have a distribution license and must meet the safety, quality and benefit requirements that must be met by manufacturers and distributors of medical devices and PKRT.

Ensuring the safety, quality, and efficacy of medical devices is done by keeping every cycle of medical devices running well, one of which is strengthening the supervision of medical devices and PKRT as well as standardizing production and distribution facilities through CPAKB, CPPKRTB and CDAKB certification for production and distribution facilities of medical devices and PKRT.

Following up on the mandate of Government Regulation No.5 of 2021 concerning the Implementation of Risk-Based Business Licensing and Permenkes No. 14 of 2021 concerning Business Activity and Product Standards in the Implementation of Risk-Based Business Licensing in the Health Sector which requires business actors to have CPAKB, CPPKRTB and CDAKB certificates, it is necessary to accelerate the certification process.

As an effort to accelerate CDAKB certification, the Directorate General of Pharmaceuticals and Health Equipment through the Directorate of Medical Device Supervision held a Coaching Clinic meeting for Medical Device Distributors in the context of CDAKB Implementation on 04 to 05 July 2022 at the Grand Kemang Hotel Jakarta.

In his report, Acting. Director of Medical Device Control, Heru Sunaryo said that CDAKB is a quality management system that must be owned by medical device distributors in carrying out distribution activities in their respective companies so that medical device products distributed are maintained in quality, efficacy and safety to customers.

The meeting, which was held offline, was officially opened by the Director General of Pharmaceuticals and Medical Devices, L. Rizka Andalucia by inviting 80 business actors of medical equipment distribution facilities.

“The purpose of this activity is to provide intensive assistance so that medical device distributors immediately apply for CDAKB certification with an accelerated mechanism through the OSS RBA system,” said the Director General.

The acceleration of CDAKB certification for business actors will include the stages of document evaluation, remote audit, on-site audit, and/or post-certification inspection adjusted to the type of distributor.

It is hoped that through the acceleration of CDAKB certification, quality assurance, safety and benefits of medical devices in circulation can be realized.