Mutual Recognition Arrangements (MRA) & Foreign Approval Recognition
ASEAN Mutual Recognitionβ
Indonesia participates in ASEAN-level discussions on mutual recognition for medical device regulation, aligned with the broader ASEAN Economic Community goals. However, formal, binding mutual recognition of individual device approvals between ASEAN member states β where Device X approved in Singapore is automatically valid in Indonesia without separate registration β does not currently exist as a general rule.
ASEAN harmonisation means mutual recognition of frameworks and standards (the CSDT format, classification system, ISO 13485 as the QMS standard), not automatic product approval transfer.
How Foreign Approvals Are Used in Indonesiaβ
While foreign approvals do not replace Indonesian registration, they can meaningfully support the review process:
| Foreign Approval | Practical Value for Indonesia NIE |
|---|---|
| US FDA 510(k) or PMA | Strong supporting evidence; FDA clearance letter and summary submitted as part of CSDT clinical/technical evidence |
| EU CE Mark (MDR) | Accepted supporting evidence; Declaration of Conformity and Notified Body certificate can be included |
| Australia TGA (ARTG) | Supporting evidence |
| Singapore HSA | ASEAN alignment means HSA approval is particularly useful; CSDT from HSA requires minimal adaptation |
| Japan PMDA | Supporting evidence |
| MDSAP certificate | See below |
MDSAP in Indonesiaβ
The Medical Device Single Audit Program (MDSAP) is a global programme that conducts a single regulatory audit of a manufacturer's quality management system, recognised by multiple regulatory authorities (Canada, USA, Brazil, Australia, Japan).
Indonesia is not a formal MDSAP participating authority. An MDSAP certificate is therefore not equivalent to an Indonesian GMP inspection and cannot replace the GMP certificate requirement in the Regalkes dossier.
However, an MDSAP certificate:
- Demonstrates a high standard of QMS compliance
- Is accepted as supporting quality evidence alongside the primary GMP/ISO 13485 documentation
- May reduce Kemenkes evaluator concerns about manufacturing quality, potentially reducing the risk of queries
Country-by-Country: What to Include in Your Dossierβ
If you hold approvals in one or more of the following markets, include the relevant approval documents in your CSDT dossier:
| Market | Document to Include |
|---|---|
| USA | FDA clearance letter + device listing number |
| EU | CE Declaration of Conformity + Notified Body certificate (MDR/IVDR) |
| Singapore | HSA device listing certificate |
| Australia | ARTG entry confirmation |
| Japan | Approval certificate (NinshΕ) or certification (Ninsho) |
| Malaysia | MDA device registration certificate |
These documents go in the administrative section of the CSDT as "overseas regulatory approvals" and in the clinical/technical evidence section as supporting material for the safety and performance claims.