The Ministry of Health continues to strive to realize more quality public services in the field of medical device distribution in order to support the growth of medical device distributors who can guarantee the quality, safety and benefits of medical devices distributed.
The Directorate General of Pharmaceuticals and Medical Devices through the Directorate of Medical Device Supervision held a Socialization on Good Medical Device Distribution Methods (CDAKB) and launched Seralkes V.3 as an effort to improve compliance and increase the ease of medical device distributors in applying for CDAKB certification.
The socialization and launching of Seralkes V.3 was held on November 5, 2024 in a hybrid manner at the Aceh Provincial Health Office and was attended by Medical Device Distributors, Provincial Health Offices and Medical Device and Facility Safety Centers throughout Indonesia.
The socialization and launching of Seralkes V.3 was held on November 5, 2024 in a hybrid manner at the Aceh Provincial Health Office and was attended by Medical Device Distributors, Provincial Health Offices and Medical Device and Facility Safety Centers throughout Indonesia.
The stipulation of CDAKB as a requirement in managing/changing distributor licenses and medical device distribution permits as well as procuring medical devices through e-catalogs, shows the commitment that must be fulfilled by medical device distributors in protecting the public from products that do not meet the requirements and pose a risk to health and safety.
The launch of Seralkes V.3 is part of the effort to modernize the application with a more attractive appearance and the development of application modules to provide convenience and transparency for businesses and officers, namely adjusting the flow of the application process based on the type of audit (onsite audit and document evaluation), CAPA process features, limiting the number and time of document corrections, and displaying service promises for more transparent public services. Seralkes V.3 will be implemented starting in 2025, for companies that are still in the process of applying for CDAKB will be migrated during the closing of the Seralkes system in 2024.
The launching of Seralkes V.3 received a positive response from stakeholders and users. Alam Cahya Diningrat, one of the participants as well as a business actor, stated that the improvement of the Seralkes system can make it easier for distributors who will make CDAKB. “There is an improved solution from the Seralkes system and makes it easier for us business actors who will make CDAKB,” concluded Alam. CDAKB certificate is not the end goal but a continuous process and continuous improvement. By continuously updating the licensing system, it is hoped that public services in the field of medical device distribution can be of higher quality and support the growth of the medical device industry overall.
