Administrative Documents
Overview
The administrative module of the CSDT dossier contains the identity, legal, and quality system documents that establish the legitimacy of the manufacturer, the LAR, and the device's regulatory standing in its home market. These documents are checked during the administrative review phase of the Regalkes process.
Required Administrative Documents
| Document | Description | Legalisation Required? |
|---|---|---|
| Letter of Authorization (LoA) | Manufacturer appoints Indonesian LAR | Yes — apostille or embassy legalisation |
| Free Sale Certificate (CFS/FSC) | Confirms the device is freely sold in the country of origin | Yes — apostille or embassy legalisation |
| GMP Certificate | Confirms the manufacturing facility operates to GMP standards | Yes (for imports) |
| ISO 13485 Certificate | QMS certification for the manufacturer | Yes — certified copy |
| IDAK Certificate | LAR's distribution licence | Provided by LAR |
| CDAKB Certificate | LAR's GDP certificate | Provided by LAR |
| Device Labels | All labels in Bahasa Indonesia (draft at submission, approved version before distribution) | No |
| IFU | Instructions for Use in Bahasa Indonesia | No |
The Critical Name/Address Consistency Rule
One of the most common causes of administrative rejection is name or address inconsistency across documents. The manufacturer's legal name and address must appear identically on:
- The Letter of Authorization
- The ISO 13485 certificate
- The Free Sale Certificate (CFS/FSC)
- The GMP Certificate
- The device label
Even minor differences — "GmbH" vs "GmbH & Co. KG", abbreviated addresses, or trading name vs registered name — will trigger a clarification query or outright rejection.
Prepare a consistency matrix listing the exact legal name and address as it appears on each document before you begin the dossier assembly. Resolve any discrepancies before submission.
Free Sale Certificate (CFS/FSC)
The CFS confirms that the device is approved and commercially available in the manufacturer's home country. Requirements:
- Issued by the relevant national competent authority (e.g. FDA for US, MHRA for UK, TGA for Australia) or a designated government body
- Must cover the specific device model being registered in Indonesia
- Must be apostilled/embassy legalised
- Validity: confirm current requirements with your LAR, as Kemenkes may specify a maximum age
GMP Certificate
For imported devices, a GMP certificate confirming that the manufacturing facility meets Good Manufacturing Practice standards is required. This may be:
- An ISO 13485 certificate (if the scope covers the device and manufacturing activities)
- A country-of-origin GMP inspection certificate issued by the competent authority
- An MDSAP certificate (for relevant manufacturing countries)
Lead Times — Plan Ahead
The legalisation chain for administrative documents is the most time-consuming part of dossier preparation. Indicative timelines:
Notarisation/authentication of LoA in home country: 1–3 weeks (varies by country and whether a notary, attorney, or government agency must perform it)
Start document preparation at least 6 months before your target submission date.
Issued by the relevant national competent authority (e.g. FDA for US, MHRA for UK, TGA for Australia) or a designated government body
Note: For devices not yet approved or commercially available in the home country, an alternative declaration of compliance or letter from the manufacturer's home authority may be accepted in some cases — confirm with your LAR whether your specific device qualifies for an alternative approach.
Revise the Free Sale Certificate (CFS/FSC) subsection to add:
Validity: As a general guideline, Kemenkes typically accepts CFS documents issued within the last 2–3 years. Confirm current maximum age requirements with your LAR, as this may evolve. Some authorities may request renewal of older certificates.