Approval Letter for the Import of Medical Devices and In Vitro Diagnostic Medical Devices via the Special Access Scheme (SAS)
-
Micro, Small, and Medium Enterprises (UMKU) Details
Parameter: All
Authority: Minister/Head of the Agency
Requirements:- Proof of Payment of Non-Tax State Revenue (PNBP) Duration: -
- Administrative Requirements Duration: -
- Technical Requirements Duration: -
-
Obligations:
- Reporting on Product Utilization within 1 (one) month Duration: -
- Reporting on Product Re-Export for Exhibitions, no later than 14 (fourteen) days after the exhibition Duration: -
- Reporting on Adverse Events or suspected adverse effects of the use of Medical Devices entering through the Single Access System (SAS), no later than 7 (seven) days after the event Duration: -
Sector: Health
Status: Not available
Belongs to:
32503
Need advice on setting up a company in Indonesia?
KBLI.co.id is a subsidiary of Emerhub, the largest independet corporate advisory firm in Indonesia.
Schedule a free consultation
Share your plans for Indonesia with us, and our advisors will recommend the most appropriate type and classification of legal entity for your needs.
No commitment required
We recognize that you might be in the exploratory phase of deciding whether and how to expand into Indonesia. Allow us to simplify this process for you.
Always credible information
Due to frequent changes in regulations and government policies, there is a prevalence of misleading and outdated advice. As we handle company registrations daily, we are well-informed about the most current information.