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KOREA → INDONESIA · KEMENKES AKL · BPOM

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.

Ask about registrationRequest a quote
KOREALoA · CFSINDONESIAKEMENKES RI
AKL / BPOM NA
15–45 daysAKL review · working days
2 wks + 2 wksBPOM facility · product notification
5 yrs · 3 yrsLicence validity · AKL / BPOM
2026.10.17Cosmetics halal transition deadline
AKL · KemenkesMedical devices

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 · NotifikasiCosmetics

Notification to BPOM, after which an NA number is issued. Two stages: manufacturer registration → product notification (DIP).

See notification steps →
01

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).

ManufacturerYour companyLoA · CFS · ISO/GMP · technical file
Dossier reviewNK Global HoldingsReview · correction guidance
Local registrantPT KMPIDAK holder · BPOM notifier
AuthorityKemenkes · BPOMAKL licence / NA number
DistributionSell with labellingRegistration no. on label
02

Device classes & review times

Bar height shows risk; the number is the statutory review period for imported devices (working days).

15 days
Class ALow riskCommon documents
30 days
Class BLow–moderateCommon documents
30 days
Class CModerate–high+ raw material specs
45 days
Class DHigh risk+ pre-clinical · clinical · risk analysis
  • 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.

03

Cosmetic notification in 2 stages

Ingredients follow the ASEAN Cosmetic Directive (ACD).

STEP 1 · Manufacturer (facility) registration · 2 working weeks
LoACFSGMP / ISO 22716BrandOEM

LoA · CFS · GMP/ISO 22716 are submitted apostilled

STEP 2 · Product notification (DIP) · 2 working weeks
I AdministrativeII Raw materialsIII QualityIV Safety · efficacy · labellingNA number issued

Valid 3 years · import within 6 months · English sticker on Korean packaging

※ Working days; may be extended without notice depending on BPOM's workload.

04

11-step process

We keep you updated at every step, from first enquiry to receiving the licence.

  1. 01EnquiryCompany · K-MBSS
  2. 02Document checklistK-MBSS
  3. 03Pre-reviewCompany → K-MBSS
  4. 04Quote · contractCompany · K-MBSS
  5. 05Upload full dossierCompany
  6. 06Review · feedbackK-MBSS
  7. 07Corrected documentsCompany
  8. 08Handover to RA · filingPT KMP
  9. 09Authority queriesAuthority → Company
  10. 10ResubmissionCompany → PT KMP
  11. 11Licence issuedAuthority → Company
05

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
06

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)
Request a quote KakaoTalkRequest by email · solution@k-mbss.com

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.

solution@k-mbss.com · +82 2-2224-0977 · Mon–Fri 09:00–17:00 KST

Email usRegistration Q&A