Sector permit (PB UMKU)

Import permit for medical devices

Izin edar alat kesehatan impor

OSS code024000000058

SectorHealth & Medical Devices

IssuerMinistry of Health (Kemenkes / BPOM)

§ 01

What is Import permit for medical devices?

Plain-English explanation of this sector permit and when a business needs it.

Import permit for medical devices is a Perizinan Berusaha Untuk Menunjang Kegiatan Usaha (PB UMKU) — a sector-specific business permit issued by Ministry of Health under Indonesia's Health regulatory regime. PB UMKU sit on top of the foundational NIB (Nomor Induk Berusaha): the NIB lets you exist as a business and operate a KBLI activity at its risk-based scale, while a PB UMKU authorises a specific regulated function, output, or facility within that activity.

Whether your business needs this permit depends on the specific KBLI activity you operate, the products or services you produce, and the scale of operations. The issuing ministry sets eligibility, application requirements, and validity terms — review the official OSS portal (oss.go.id) for the current procedure, or engage a licensed business-services provider to handle the filing end-to-end.

§ 02

What you need to file

6 application requirements the regulator wants to see at submission. Emerhub assembles and files the bundle on your behalf.

Application requirements

Source: OSS — kbli.co.id surfaces them here so you know what we'll need to gather from you. The actual filing is handled by Emerhub.

01
Administrative Requirements
02
Technical Requirements and
03
Proof of PNBP payment
04
Administrative requirements include:
1. Business licensing for the distribution of medical devices
2. For imported medical devices that perform primary packaging, attach business licensing UMKU certification of good manufacturing practices for medical devices (CPB for alkes)
3. Letter of agency appointment from the manufacturer/principal certified by the representative of the Republic of Indonesia in the country of origin, valid for a maximum of 5 (five) years from the date of agency appointment
4. Certificate of Free Sales (CFS) that is still valid and issued by the competent authority in the country of origin
5. Letter of statement willing to relinquish agency, stamped
6. Valid brand certificate for imported OEM medical devices
7. Letter of statement of document authenticity, stamped
8. Integrity pact for the prevention of corruption, collusion, and nepotism, stamped
9. Standard Operating Procedure (SOP) and recording system regarding customer complaint handling, adverse events, product recalls, and other product information related to post-market (*for new applications)
05
Technical requirements include:
1. Quality management system documents such as Good Distribution Practice (GDP) certificates for Medical Devices, ISO, and CE certificates
2. Declaration of conformity from the manufacturer
3. Product information
4. Specifications and quality assurance
5. Labeling requirements
06
Proof of payment for Non-Tax State Revenue (PNBP)

§ 03

Ongoing obligations once issued

5 obligations that continue throughout the life of the permit — periodic reports, recordkeeping, technical compliance.

Recurring compliance

Lapsed obligations can trigger NIB suspension. Emerhub manages the filing calendar end-to-end as part of monthly compliance.

01
Periodic reports twice a year.
02
Incident Report (KTD), if there is an undesirable event.
03
Periodic reports twice a year.
04
Incident Report (KTD), if there is an undesirable event.
05
Periodic reports twice a year
1. Report on Unwanted Events (KTD), if there are any unwanted events

§ 04

Issuing authority

OSS records 2 authority routing rules for this permit, depending on the applicant's situation.

Ministry of Health

Sector regulator for Health in Indonesia.

Issuing authority	Applies when
—	All applicants
—	All applicants

§ 05

Where this permit fits in the OSS licensing flow

Indonesia's risk-based OSS licensing process — and where this PB UMKU sits within it.

01
Set up the legal entity
Foreign investors incorporate a PT PMA (Perseroan Terbatas Penanaman Modal Asing); domestic investors use a PT lokal or PT Perorangan. The Articles of Association are drafted before a notary and registered with Kemenkumham (Ministry of Law & Human Rights).
02
Obtain the NIB via OSS
File the OSS application with your KBLI codes and risk-based scale. The system issues an NIB (Nomor Induk Berusaha) — your foundational business identifier. For low-risk activities, the NIB alone is sufficient to begin operations.
03
Apply for {permit}
Submit the PB UMKU application through OSS, addressed to Ministry of Health. Required supporting documents and processing time are set by the ministry; expect technical review, possible site inspection, and clarification rounds before issuance.
04

Need help with this permit?

Emerhub is a licensed corporate-services provider in Indonesia. We handle PT PMA and PT lokal incorporation, OSS NIB application, and sector-specific PB UMKU filings — including Import permit for medical devices via Ministry of Health. Get an exact quote and timeline scoped to your specific business.

Request a quote

Issuing authority

Applies when

—

All applicants

—

All applicants

Need help with this permit?

What is Import permit for medical devices?

What you need to file

Application requirements

Ongoing obligations once issued

Recurring compliance

Issuing authority

Ministry of Health

Where this permit fits in the OSS licensing flow

Set up the legal entity

Obtain the NIB via OSS

Apply for {permit}

Which businesses need this permit?

3 KBLI codes declare this permit applicable

Common KBLI codes in Health

Need help with this permit?

What is Import permit for medical devices?

What you need to file

Application requirements

Ongoing obligations once issued

Recurring compliance

Issuing authority

Ministry of Health

Where this permit fits in the OSS licensing flow

Set up the legal entity

Obtain the NIB via OSS

Apply for {permit}

Which businesses need this permit?

3 KBLI codes declare this permit applicable

Common KBLI codes in Health

Need help with this permit?

Operate + maintain compliance