E-SUKA: Streamlining Certification for Medical Devices and Health Products

The era of globalization has led to ease in and out of the goods including medical devices and household-health products. Rapidly growing technology of medical devices causes people frequently need either information for personal needs, company, or public facility. Product information, such as from E-SUKA, is also required in doing export-import of medical devices and household-health products to perform the registration process. 

To meet the public’s information needs, the Directorate of Medical Devices and Household Health Products offers a streamlined certification service via the ESUKA platform. Available at http://esuka.binfar.kemkes.go.id, ESUKA (e-System for Medical Device and Health Product Certificates) simplifies and manages the certification process effectively. ESUKA aims to enhance efficiency by facilitating access to information through a well-managed certification service, ensuring that the process runs effectively and efficiently.

Type of Certificate

The Directorate General of Pharmaceutical and Medical Devices, through its Directorate of Medical Devices and Household Health Products, issues various certificates, including E-SUKA-related documents:

1. Certificate of Free Sale (CFS)
2. Certificate of Exportation
3. Health Certificate
4. Special Access Scheme (SAS)
5. Certificate of Sample Importation for Marketing Authorization
6. Certificate of Importation of Raw Materials
7. Certificate of Importation of Spare Parts
8. Certificate of Product Information for Companies/Individuals
9. Certificate of Importation (Customs)
10. Certificate of Importation Authorization
11. Certificate of Advertisement Approval
12. Certificate of Promotional
13. Certificate of Recommendation for Importation Approval
14. Other Information Certificates

Cost of Certificate Service Process

The process of certificate service is divided into two stages: initial evaluation and final evaluation. After completion of the initial evaluation, the applicant will receive payment instruction of Nontax state revenue according to applicable regulations, as found on E-SUKA.

Related Links:

• Key Components of CDAKB
• BPOM and Jordan FDA Enhance Cooperation in Drug and Food Supervision
• Understanding the CDAKB Certification Process
• Certificate of Production for Medical Devices and PKRT
• Understanding the Certificate of Free Sale (CFS)