Certificate of Free Sale for Indonesian Registration: Sources, Common Defects and Legalisation

1. Key takeaways

The Certificate of Free Sale is mandatory for imported products and cannot be waived. For imports, Kemenkes requires a Certificate of Free Sale issued by the appropriate authority in the country of origin. Together with the LoA and the ISO 13485 certificate, it forms the administrative document set — a trio that is not exemptible. A submission that is complete except for the CFS is not nearly complete; it is incomplete in a way that no other document can compensate for.

The CFS is also a living document rather than a one-time attachment. It carries a validity period, commonly around 2 years, and it must remain valid across an Indonesian registration cycle that routinely takes months. Planning its issuance and renewal as part of the project calendar, rather than as a checkbox before submission, is what keeps the administrative set intact through the review.

• Who issues it for Chinese manufacturers: the drug regulatory authority issues an export sales certificate for products already registered in China; for products not registered domestically, the local drug regulatory authority issues the corresponding certificate.
• Four common defects: incomplete model coverage, intended-use wording inconsistent with the submission, expiry, and an issuing body that is not recognised.
• Legalisation: required — apostille route or traditional embassy legalisation.
• Do not confuse: Kemenkes itself also issues a CFS, but that one serves Indonesian products exported abroad, not import submissions.
• Timing discipline: work back from the submission date plus a 12-month margin, and manage expiry in the standing ledger.

2. Legal basis

The administrative requirement for a CFS appears in Permenkes No. 62/2017, Annex II A (administrative requirements, item 4), now carried forward under Permenkes 5/2026, and in Permenkes No. 11/2025, Appendix 3. Legalisation follows the Hague Apostille route — Indonesia has been a Convention party since 4 June 2022 — or the traditional embassy route. The references below were verified on 26 October 2026.

The confusion point is worth stating plainly: Kemenkes also issues a CFS — at a PNBP fee of Rp500,000, processed in 3 working days and valid for 2 years — but that document is for Indonesian products being exported, not the one required for an import submission. The two share a name and point in opposite directions. Mixing them up wastes an application fee and a scheduling window, so the direction of the certificate should be confirmed on every file.

3. Expert insights

Insight 1: the four recurring defects are all avoidable at the request stage. The failures seen in practice are: ① incomplete model coverage — the CFS names only the main model while the submission includes accessories and specifications that are not listed; ② intended-use wording inconsistent with the submission; ③ expiry — a CFS generally carries a validity period, commonly 2 years, and must be renewed before it lapses; and ④ an issuing body that is not recognised — certificates from non-official bodies or industry associations are usually not accepted. Each defect traces back to how the certificate was requested from the issuing authority, not to anything that happens later.

Insight 2: for products not registered in China, confirm local practice early. Where a product has no domestic registration, the corresponding certificate must come from the local drug regulatory authority, and local approaches vary. The practical question to resolve in advance is whether the local authority’s certificate can cover the models and intended uses of the Indonesian submission. Asking that question after the dossier is assembled means discovering, with everything else ready, that the anchor administrative document does not fit.

Insight 3: choose the legalisation route once, at project start, with the licence holder. The apostille path is available since Indonesia joined the Convention on 4 June 2022, and the traditional embassy path remains open. Which one to use depends on the nature of the issuing body and the licence holder’s operating experience. The recommendation is to confirm the route with the licence holder once at project launch — the avoidable failure is having the complete document set, only to find the legalisation path chosen does not match what the reviewer expects.

4. Practical recommendations

• Request the CFS with the full submission scope in view. Ensure every model, accessory and specification to be registered appears on the certificate, not only the main model.
• Align intended-use wording. Check the certificate’s description of the product against the submission before it issues, while wording changes are still cheap.
• Use an official issuer. Obtain the certificate from the drug regulatory authority or another body recognised for this purpose; industry association documents are usually not accepted.
• Plan issuance backwards from submission plus 12 months. The Indonesian registration cycle runs to months, so the certificate should hold validity well beyond the filing date.
• Enter the CFS into the standing expiry ledger (see article 18) and manage renewal as a tracked item rather than a memory task.
• Confirm the legalisation route with the licence holder at project start — apostille or embassy — and obtain the stamp accordingly.

The underlying discipline is calendar-based: a CFS is a document with a validity period, and Indonesian registration is a process with a duration measured in months. Treating the two as an integrated schedule — issuance timed to the submission date plus a 12-month margin, expiry tracked in the ledger — removes one of the simplest ways an otherwise sound submission goes deficient.

5. Verification checklist

• □ CFS obtained from a recognised official authority in the country of origin
• □ All submitted models, accessories and specifications listed on the certificate
• □ Intended-use wording on the certificate consistent with the submission
• □ Validity confirmed and renewal date entered in the expiry ledger
• □ Legalisation route chosen with the licence holder: apostille or embassy legalisation
• □ Export-use and import-use CFS distinguished; the Kemenkes-issued export CFS not substituted
• □ Requirement confirmed against Permenkes No. 62/2017 Annex II A item 4 and Permenkes No. 11/2025 Appendix 3

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Indonesia. Our team prepares dossiers to ASEAN CSDT structure, manages AKL/AKL-I submissions with Kemenkes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com