SERVICE — 01
Regulatory Advisory
Getting a medical device, IVD or medical software legally on the Indonesian market — from working out which class it falls in, to holding a valid Izin Edar and knowing what happens after approval.
The problem this solves
Most entry projects do not fail on the science. They fail on sequence.
- The licence is issued to your Indonesian distributor, not to you — so choosing that partner badly is expensive and slow to undo.
- An intended-use statement written for the EU or US market is frequently broader than Indonesia will accept, and that is discovered after submission rather than before.
- Review clocks only run while the dossier is with the ministry. Time spent fixing a returned dossier is your time, not theirs.
What we do
Four blocks. Most engagements use all four; some start mid-way.
- Classification and pathway assessmentWhere the product sits in the A–D risk classification, whether it is treated as a device at all, and what that implies for evidence, timeline and cost. Delivered before you commit budget.
- Distributor identification and qualificationShortlisting candidate distributors and checking what actually matters: a valid Distributor Alat Kesehatan licence (IDAK), a current Sertifikat Cara Distribusi yang Baik (CDB), the product categories they are permitted to handle, and their track record.
- Dossier preparation and gap analysisMapping your existing technical file against what Indonesia requires, naming the gaps in writing, and preparing the submission package — Certificate of Free Sale, declaration of conformity, quality-system evidence, labelling and instructions for use.
- Submission and post-approvalManaging the interaction with the Ministry of Health through OSS, handling correction rounds, and setting up the post-market obligations that renewal will later depend on.
Where the current rules come from
So you can check the basis of anything we tell you.
- Permenkes No. 11 Tahun 2025 — business-activity and product/service standards under risk-based business licensing in the health subsector, issued 3 October 2025. This is where Izin Edar now sits, as a PB UMKU processed through OSS.
- Peraturan Pemerintah No. 28 Tahun 2025 — the risk-based business licensing framework the above implements.
- ASEAN Medical Device Directive — the basis for the A–D risk classification and the CSDT dossier structure.
A terminology check worth running on any document you have been given.
Permenkes 11/2025 refers throughout to a Sertifikat Cara Distribusi yang Baik — CDB. The older abbreviation CDAKB does not appear in it at all. Material still using CDAKB was written against an earlier framework, and the rest of it may be equally out of date.
Not sure whether your product even needs this?
That is the most common opening question, and it is answerable in one call. A 30-minute conversation is usually enough to tell you whether your pathway is straightforward or complicated — which is useful either way.
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