Registration Q&A

No. Medical devices (AKL) must be filed by a local entity holding an IDAK, and cosmetics (BPOM) by a locally registered notifier. The manufacturer issues a Letter of Authorization (LoA) to that entity; K-MBSS files through its local entity, PT Korea Medibiz Platform (PT KMP).

Enquiry → document checklist → pre-review (feasibility and expected class) → quote & contract → full dossier → review & corrections → final check and filing by the local RA team → responses to authority queries → licence issued.

Statutory review for imported devices is 15 working days for Class A, 30 for B and C, and 45 for D. Cosmetics take 2 working weeks for manufacturer registration and 2 for product notification. Authorities may extend these without notice. Document preparation — especially apostilles for the LoA and CFS — can add 4–8 weeks.

Before contracting, we check feasibility, the expected class and any extra documents using your home-country approval, ISO/GMP certificates, product information and HS Code. For cosmetics we also screen for prohibited and restricted ingredients at this stage.

For devices, replies are due within 10 days (Class A–C) or 15 days (Class D) of the query. K-MBSS translates the query, tells you what is needed and resubmits through the local RA team. Missing the deadline can lead to rejection.

Your account manager emails you whenever the stage changes, and sends review results and correction requests itemised.

English. Korean documents (e.g. MFDS approvals) are submitted with an English translation. The device IFU and key label text must be translated into Indonesian; K-MBSS supports the translation review.

In Korea, at the Ministry of Foreign Affairs consular service or online via e-Apostille. Private documents such as a company-issued LoA must be notarised first, then apostilled.

Filing is done by uploading scans to the online system. Keep the apostilled LoA and CFS originals, as the authority may ask to verify them.

Organise them as PDFs according to the checklist and email them to [email protected]. Including the document and product name in each file name speeds up the review.

Product/model names, manufacturer name and address must be identical across all documents — including spacing and capitalisation. It is the most common reason for queries, so we cross-check item by item.

Indonesia classes devices A (low risk) to D (high risk). It is broadly similar to Korean classes but can differ by intended use and principle, so we confirm it in the pre-review.

Yes. The class lists are the rule; additional data may be requested depending on principle, materials, sterilisation, software, body contact and claims. Class C products, for example, are sometimes asked for pre-clinical or clinical data.

Models with the same principle, intended use and materials can sometimes be grouped in one application. Whether grouping is possible depends on the configuration and is checked in the pre-review.

The ISO 13485 certificate must have at least one year of validity remaining. A CE certificate is submitted with a letter confirming it is valid.

Exact names and addresses of the manufacturer and the local registrant, the products (models) covered, the term (2–5 years), and the representative's signature and seal — written in English and apostilled. The licence validity follows the LoA term.

Show product name, licence number (KEMENKES RI AKL), names and addresses of the manufacturer and importer (PT KMP), lot/serial number and expiry date; intended use, directions, contraindications, precautions and warnings must be in Indonesian. Superlatives and definitive efficacy claims are not allowed.

Product name, manufacturer or address differing between documents; test reports showing another product name; self-made documents without manufacturer letterhead; DoCs missing the applied standards; approvals in Korean only; and missing Indonesian IFUs.

It must be applied to external parts of the body (skin, hair, nails, lips, external genitalia, teeth, oral mucosa) for cleansing, fragrance, changing appearance, correcting body odour or protection. Oral, injectable or internal products, or products claiming to treat or prevent disease, are not cosmetics.

Not necessarily. Indonesia follows the ASEAN Cosmetic Directive (ACD), with restricted ingredients in Annex I and prohibited ones in Annex V. A product sold in Korea cannot be registered if it contains a prohibited ingredient.

Claims that could be mistaken for medicines — treating, regenerating, relieving inflammation — and unsupported superlatives. Any efficacy claim must be backed by evidence.

Either, submitted apostilled. Using the CFS of the same company named in the LoA reduces additional requests.

Yes. Submit a valid ISO 22716 certificate from an accredited body, apostilled.

Either may apply, but a trademark licence agreement between the two must be submitted. The OEM agreement must state the brand, product names and expiry date, and the manufacturer name must match the GMP certificate exactly.

An English sticker must be added, showing product name, ingredients, manufacturer and Indonesian importer/distributor (PT KMP), directions and a space for the BPOM number.

Product testing is not generally required at notification, but post-market sampling can occur, so keep finished-product CoA and microbial/heavy metal test data ready.

Devices: up to 5 years following the LoA term; OEM-manufactured products up to 3 years. Renewal can be filed from 9 months before expiry. Cosmetics: 3 years, renewed before expiry.

Cosmetics must be imported and distributed within 6 months of notification. Device renewals also check distribution records, so renewal may be difficult without sales.

Changes to the product name, manufacturer address, labelling/packaging or (for cosmetics) ingredients require a variation. Some changes require a new registration, so please consult us before changing anything.

The licence is issued in the name of the filing entity. Other companies can sell under a distribution agreement with the licence holder. Changing the licence holder itself normally means re-registering under a new LoA.

Work to keep the licence active — liaison with the authority, periodic reports and licence status management. Paid once a year after registration.

Three items per product: government fee (PNBP), registration fee and annual maintenance. Fees depend on class or type, number of products and document readiness — send us your product details for a tailored quote.

Within 7 days of contract: PNBP 100% and 60% of the registration fee. Within 7 days of licence issue: the 40% balance and 100% of the annual maintenance fee. Same for devices and cosmetics.

Registration fees are negotiable when two or more products are registered together.

After the quote, we sign our standard contract. Download, sign and seal it, then send us the scan.

If a licence cannot be obtained due to errors or omissions in submitted documents, or uncontrollable causes such as Indonesian policy changes, fees already paid are not refunded (Standard Contract, Article 5). That is why we put so much into the pre-review and dossier review.