ASEAN CSDT
The ASEAN Common Submission Dossier Template (CSDT) used for Indonesian medical device registration — structure, modules, and how it differs from EU MDR or FDA formats.
Administrative Documents
Administrative documents required for Indonesia medical device registration — LoA, Free Sale Certificate, GMP certificate, ISO 13485, IDAK, and consistency rules.
Technical Documents
Technical documentation requirements for Indonesian medical device registration — device description, biocompatibility, sterility, electrical safety, and performance testing.
Risk Management
ISO 14971-based risk management requirements for Indonesian device registration — risk analysis, risk control, residual risk, and the risk–benefit analysis for Class C/D devices.
Clinical Evidence
Clinical evidence requirements for Indonesian medical device registration by class — literature review, clinical evaluation reports, and local clinical investigation data.