After all the documents are prepared, these are the procedures of registration:
These are the documents required in order to register medical devices in Indonesia:
Business Identity Number (NIB), Company’s Tax ID (NPWP), Medical Device Distribution License (IDAK)
Free Sales Certificate, ISO 13485 certificate (for imported products)
Dossier from manufacturer, in accordance to the ASEAN Common Submission Dossier Template (CSDT) which includes:
Medical device registration in Indonesia requires the preparation of multiple documents. Double M strives to help our clients throughout the whole process and submit the application successfully. Should you have any inquiries, please contact us.