The Directorate General of Pharmaceutical and Medical Devices through the Directorate of Medical Device Control held a Post-Certification Inspection Training on Good Medical Device Distribution Practices (CDAKB) on 19-21 June 2024 in Jakarta.

This activity was attended by representatives of the Medical Devices and Health Facilities Safety Center (BPAFK) and the Medical Devices and Health Facilities Safety Workshop (LPAFK).

The training aims to train inspectors in carrying out inspections to medical device distribution facilities that have obtained CDAKB certificates. CDAKB certificates are awarded to distributors or distributor branches that have been audited and fulfill the CDAKB principles.

To ensure consistent implementation of CDAKB principles. Post-certification inspections are an important step in ensuring that medical device distributors continue to comply with the standards applied in accordance with the certificate granted.

Eka Purnamasari, Director of Medical Device Control, when opening the training conveyed the importance of in-depth understanding of CDAKB regulations. “As units that take part in supervising health distribution facilities, BPAFK and LPAFK need to be given an understanding of the CDAKB regulation. This is important so that business actors continue to implement a quality management system so that medical devices circulating in the community are guaranteed quality, safety and benefits,” Eka said.

Furthermore, Eka explained that the safety, quality, and benefits of medical devices are greatly influenced by the distribution process, starting from manufacturers, distributors to delivery to patients or the public. “Through a good distribution process, we can ensure that medical devices reach the hands of users in good condition and in accordance with established standards,” she added.

Eka hopes that this training can strengthen the understanding of BPAFK and LPAFK regarding the aspects of CDAKB. Thus, when carrying out inspections, the inspectors have a good understanding of what to check in the medical equipment distribution facilities.

In addition to providing theoretical training and workshops, this activity also includes simulations of medical device supervision inspections conducted at health offices and hospitals. This simulation aims to provide participants with practical experience in applying the knowledge learned during the training, as well as preparing them to conduct effective and standardized inspections.