Register your medical devices
& cosmetics in Indonesia
From the document checklist and dossier review to submission through our local entity (PT KMP) and receipt of the licence — K-MBSS handles the entire Indonesian product registration process with you.
AKL / BPOM NA
Import licence from the Ministry of Health (Kemenkes). Devices are classed A–D by risk, and required documents differ by class.
See classes & review times →BPOM · NotifikasiCosmeticsNotification to BPOM, after which an NA number is issued. Two stages: manufacturer registration → product notification (DIP).
See notification steps →Licences held by PT KMP
K-MBSS is not a broker. Applications are filed directly by our Indonesian company, PT Korea Medibiz Platform, which holds the licences below.
Qualifies us to file AKL import registrations directly
- No.
- 13062400818690005
- Issued · valid
- 2025-03-10 – 2029-09-27
Issued after a full facility audit · Scope: non-radiation electromedical, sterile and non-sterile non-electromedical devices, in-vitro diagnostics
- No.
- PB-UMKU 130624008186900050001
- Issued · valid
- 2025-07-28 – 2030-07-28
Qualifies us to file BPOM cosmetic notifications (NA numbers) directly
- No.
- PB-UMKU 130624008186900060005
- Issued · valid
- 2025-06-26
PT Korea Medibiz Platform · 8 KBLI incl. wholesale of pharmaceuticals, cosmetics and medical devices
- No.
- 1306240081869
- Issued · valid
- PMA · API-U
Registration track record
All numbers can be checked on Indonesia's OSS system (oss.go.id). Copies of the licences are provided during contract consultation.
Who does what
A foreign manufacturer cannot apply in Indonesia directly. A locally registered entity applies on the manufacturer's behalf under a Letter of Authorization (LoA).
Device classes & review times
Bar height shows risk; the number is the statutory review period for imported devices (working days).
- Filed via regalkes (OSS) by a local IDAK holder
- Valid up to 5 years, tied to the LoA term (2–5 years)
- Class lists are the rule; extra documents may be requested per product
※ 15 · 30 · 30 · 45 days are working days and may be extended without notice depending on the authority's workload.
Cosmetic notification in 2 stages
Ingredients follow the ASEAN Cosmetic Directive (ACD).
LoA · CFS · GMP/ISO 22716 are submitted apostilled
Valid 3 years · import within 6 months · English sticker on Korean packaging
※ Working days; may be extended without notice depending on BPOM's workload.
11-step process
We keep you updated at every step, from first enquiry to receiving the licence.
- 01EnquiryCompany · K-MBSS
- 02Document checklistK-MBSS
- 03Pre-reviewCompany → K-MBSS
- 04Quote · contractCompany · K-MBSS
- 05Upload full dossierCompany
- 06Review · feedbackK-MBSS
- 07Corrected documentsCompany
- 08Handover to RA · filingPT KMP
- 09Authority queriesAuthority → Company
- 10ResubmissionCompany → PT KMP
- 11Licence issuedAuthority → Company
Required documents
All documents in English. Product name, manufacturer name and address must match across documents — down to spacing.
Medical device AKL
Pre-review: home-country approval · ISO 13485 · catalogue · IFU · HS Code
- AAdministrative
- LoA (English, apostilled), CFS, ISO/CE, Executive Summary, DoC, trademark proof, home-country approval (English)
- BProduct information
- Description & features, intended use, indications, directions, contraindications · warnings · precautions, MSDS, manufacturing process
- CQuality & specifications
- Performance specs, design verification · sterilisation, packaging specs, test reports · extra data for Class C/D
- DLabelling
- Artwork (importer · AKL no. field), symbol glossary, Indonesian IFU, lot system
- EPost-market
- Complaint, adverse event and recall procedures
Cosmetics BPOM
Pre-review: full ingredient list (INCI · %) · CGMP/ISO 22716 · label images · product brochure · HS Code
- MManufacturer registration
- LoA · CFS · GMP/ISO 22716 (apostilled), brand proof, OEM agreement
- IAdministrative
- Room-temperature storage statement, manufacturer data, ingredient · function · concentration table
- IIRaw materials
- Raw material specs & methods (fragrance IFRA), raw material CoA · MSDS
- IIIQuality
- Formula, manufacturing process, batch coding, finished product CoA, microbial · heavy metal tests, stability
- IVSafety & labelling
- Safety assessment (MoS), adverse effect records, efficacy evidence, label text · sticker
Request a quote
Registration fees depend on class or type, number of products and document readiness. Send us the details below and we will quote within one business day.
Fee components
- ① PNBP — Indonesian government fee
- ② Registration service — review, localisation, filing and responses
- ③ Annual maintenance — authority liaison and periodic reports after registration
What we need for a quote
- Product names and number of items
- Type (medical device / general, functional or professional cosmetic)
- Korean class (MFDS) and HS code
- Certificates held (MFDS, CE, FDA, ISO 13485)
Can your product be registered in Indonesia?
Send us the product name, registration type (device/cosmetic), home-country class and HS Code — we will tell you whether it can be registered and the expected cost.
[email protected] · +82 2-2224-0977 · Mon–Fri 09:00–17:00 KST