🇮🇩 Indonesia medical device regulatory data

If the extension application is filed after the validity has expired, it follows the rules for a new izin edar application; once validity has expired without an approved extension, the device is prohibited from circulation. Products whose izin edar has expired and was not extended must be withdrawn from distribution (recall ground) and are subject to destruction.

The authorization holder must file the extension application at the earliest 9 months before the validity expires (paling cepat 9 bulan sebelum masa berlaku habis). Device izin edar is explicitly excluded from the general 6-months-before-expiry OSS extension rule of PMK 26/2018 Pasal 87(1) (exemption letter a). Before applying, the holder must have submitted electronic production/distribution reports (e-Report); a renewal cannot be processed if reporting was nil for the 2 years preceding expiry.

The device/PKRT izin edar is valid for at most 5 years; where held through a sole/exclusive agency appointment the validity follows the appointment (which must run at least 2 and at most 5 years; if unlimited or over 5 years, the izin edar runs 5 years from the appointment); OEM-product izin edar is valid at most 3 years. Validity may be extended if requirements are met.

Under the electronic integrated licensing regime (PMK 26/2018, in force 12 July 2018), the business licence (Izin Usaha) is valid for as long as the business operator runs its business, while commercial/operational licences are valid 5 years and extendable; branch device-distribution licences follow the head-office certificate.

An izin edar change (perubahan) is available for changes of: size; packaging; labelling; accessories/annexes to the authorization; and name/address of the representative empowered by the manufacturer - processed without changing the izin edar number. OSS standards additionally provide variation services for changes of technical responsible person, product type and premises layout.

Any change other than size, packaging, labelling, accessories/annexes or the authorized representative's name/address requires a new izin edar application (e.g. product, manufacturer or functional specification changes).

Termination of the producer's appointment of the distributor/importer is an explicit ground for revocation of the device izin edar (PMK 5/2026 Pasal 51(1)(d)), and the izin edar lapses when the appointment as sole/exclusive agent or power of attorney expires or is not extended (PMK 62/2017 Pasal 25(d)). A new appointed importer must therefore register the product anew (one importer per brand, Pasal 13).

Import izin edar applications are filed by: (a) the Sole Agent/Sole Distributor/Exclusive Distributor; (b) a licensed importer (PAK) appointed and empowered by the manufacturer/principal; (c) a PAK owning the product with a cooperation agreement with the manufacturer; (d) a PAK performing assembly; or (e) a PAK performing repackaging. Domestic applications are filed by the producer, toll manufacturer, assembler, product-owner PAK with cooperation agreement, or OEM producer.

Each type of imported device/PKRT with one trade name/brand from one manufacturer or principal may be agency-held by only one PAK (licensed importer) or PKRT importer.

The Minister of Health (Menteri Kesehatan) of the Republic of Indonesia is the authority for medical devices and household health supplies (PKRT); the responsible unit is the Director General for pharmaceutical and medical device affairs (Direktur Jenderal Kefarmasian dan Alat Kesehatan).

Under PMK 5/2026, safety/quality control of devices (Alat Kesehatan) and PKRT is performed by the Minister of Health, while control of Sediaan Farmasi and PKMK is performed according to regulations of the head of the non-ministerial government agency for food and drug supervision (BPOM).

Framework chain: Law 17/2023 on Health (Pasal 138, 143) as primary law; Permenkes 5/2026 on Perbekalan Kesehatan (in force 4 May 2026) as the operative device framework, revoking PMK 62/2017 (izin edar) and PMK 60/2017 (import surveillance); PMK 14/2021 (OSS risk-based business/product standards) remains in force; PMK 62/2017 implementing rules continue to apply insofar as not contradictory (PMK 5/2026 Pasal 124).

Implementing arrangements for health-supply regulation must be adjusted to PMK 5/2026 within at most 1 year from its promulgation (i.e. by 4 May 2027); until then pre-existing implementing rules continue unless contradictory.

PMK 5/2026 revoked several device regulations but preserved parts: PMK 4/2014 (CDAKB/GDPMD) survives except Pasal 2 and its Annex; PMK 20/2017 (CPKB/device GMP) survives except Pasal 2 and Annexes I-II; PMK 63/2017 (device clinical-trial GCP) survives except Pasal 8, 9, 11, 12, 18, 19, 20 and Annexes I-II.

Alat Kesehatan (medical device) is defined as any instrument, apparatus, machine, equipment, implant, in-vitro reagent and calibrator, software, or similar material used on humans for medical purposes whose principal action is not achieved by pharmacological, immunological or metabolic means. IVDs (in-vitro reagents and calibrators) and software are inside this single definition; the former separate 'Alat Kesehatan Diagnostik In Vitro' category of PMK 62/2017 no longer appears as a distinct licence category in PMK 5/2026. PKRT (household health supplies) is a separate defined category.

Health supplies (including all medical devices and PKRT) may only be placed on the market after obtaining the business licence in the form of an izin edar (marketing authorization); the licensed product must meet safety, efficacy/benefit and quality criteria.

Certain home-use class A devices qualify for an 'izin edar notifikasi' (notification marketing authorization) with simplified requirements. 'Certain class A' means home-use devices usable independently without special skill/health personnel, that are not sterile and not IVDs. PKRT classes 1 and 2 have an analogous notification route.

The local licence holder (imported products: appointed Indonesian distributor/PAK; domestic: producer) applies for izin edar by class-based evaluation through the Kemenkes e-Regalkes portal (regalkes.kemkes.go.id), after OSS-RBA business licensing; izin edar certificates and rejection letters are issued digitally.

Import izin edar applications must be accompanied by a Certificate of Free Sale (CFS) issued by the health authority of the country of manufacture; if that authority does not issue CFS, it may be issued by the health authority of another country regulating devices, or (if the product is not registered in the origin country) by another institution in the origin country. The CFS must state at least trade name/brand, product type, manufacturer name and address, and validity.

Indonesia does not operate a reliance route that recognizes a foreign marketing authorization in place of local review: import of devices may only take place after an Indonesian izin edar from the Minister (PMK 5/2026 Pasal 58(4)), and all classes A-D are evaluated under the PMK 14/2021 dossier standards. Foreign evidence is accepted as dossier elements only (ISO 13485/ISO 9001 certificate, CE certificate where CE-marked, Declaration of Conformity, CFS).

Distribution of medical devices may only be performed by pharmaceutical-management facilities, device producers, and device distributors holding a business licence (perizinan berusaha); distribution must follow Cara Distribusi yang Baik (CDB), and the CDB for devices is set by the Minister.

A device distributor (Distributor Alat Kesehatan) must be a limited company (PT) or cooperative and holds an Izin Distribusi Alat Kesehatan (Izin DAK/IDAK) under KBLI 46691. The business licence is valid 5 years and must be extended; the extension requires holding a CDAKB (GDPMD) certificate, and a full-time technical responsible person (PJT) with CDAKB training certificate is required.

A branch distributor licence requires: non-individual business (PT/cooperative), PNBP payment, the head office's Izin DAK, the head office's CDAKB certificate, technical responsible person data, a statement to comply with CDAKB, with 1 year from OSS approval to fulfil the requirements; the branch licence validity follows the head-office certificates.

Import of devices/PKRT may proceed only after obtaining an izin edar from the Minister; imports are processed through an electronic system integrated with the Indonesia National Single Window (INSW). In special circumstances the Minister may issue an import certificate (surat keterangan impor) for devices/PKRT, and used (non-new) devices may be imported for certain purposes subject to safety, benefit and quality requirements.

For new, extension, variation and extension-with-variation import applications: valid Izin DAK covering the product group; agency appointment letter (surat penunjukan keagenan) from the manufacturer/principal legalized by the Indonesian government representative in the origin country, valid max 5 years; valid CFS from the origin country authority; stamped declaration of willingness to relinquish the agency; trademark certificate for OEM imports; stamped statement of document authenticity; integrity pact; PNBP payment (non-refundable). New applications must additionally submit SOPs for complaint handling, adverse events, product recall and other post-market product information.

Technical dossier for import classes A-D must include an ISO 13485 certificate (latest edition) from an accredited certification body naming the manufacturer as on the CFS, with scope covering the device type; where devices are not regulated in the manufacturer's country, ISO 9001 is accepted; a CE certificate must be included if a numbered CE mark is on the labelling; plus the manufacturer's Declaration of Conformity against the standards used (SNI, ISO, pharmacopoeia etc.). Domestic applications accept SNI ISO 9001/ISO 9001 and/or SNI ISO 13485/ISO 13485, CE certificate if CE-marked, and a CPAKB (device GMP) certificate where already held.

Product registration runs on e-Regalkes (regalkes.kemkes.go.id, User-ID login) integrated with OSS-RBA; import documentation runs through INSW; the e-SUKA portal (esuka.kemkes.go.id, Directorate of Production and Distribution of Medical Devices) unifies 10 certificate types including CFS, Certificate of Export, Health Certificate and Research-Use-Only certificates, with PNBP e-payment. Related systems: SIKLARA, e-Watch, e-Report, infoalkes, e-Iklan.

Device/IVD labels and information must state at least: trade name/brand; izin edar number; product type; manufacturer name and address; name and address of the authorization-holder PAK; batch/production code/serial number; the word 'steril' and sterilization method for sterile products; product specifications; intended use and instructions for use; expiry date where applicable; and for certain devices that must be used by competent professionals the warning 'Hanya Boleh Digunakan oleh Tenaga Profesional' or the letter 'P' in white on black background.

Intended use/purpose, instructions for use, contraindications, cautions and warnings on device labelling and information must be in Bahasa Indonesia; languages other than Indonesian are permitted only where no Indonesian equivalent exists or can be created, or for goods traded abroad.

Production of health supplies must comply with Cara Pembuatan yang Baik (CPB), evidenced by a certificate issued under the applicable rules; the CPB for devices and PKRT is set by the Minister. Production facilities need full-time competent responsible persons with CPB training certificates, and contract/licence manufacturing must likewise hold a CPB certificate for the product type produced.

Every izin edar application is subject to a non-tax state revenue (PNBP) charge payable by e-payment (manual only in force majeure); fees already paid cannot be refunded, including for expired or rejected applications.

When additional documentation is requested, the applicant must complete it within at most 10 days of the notification for classes A, B and C, and 15 days for class D; if the deadline is missed the application expires and the PNBP fee is forfeited.

After generating the billing code, the applicant must pay the PNBP and upload the payment receipt within at most 7 days; the application is then routed to the PNBP admin for verification before evaluation.

Registered devices and PKRT (domestic and imported), licensed distributors (IDAK) and producers are listed in the official public registry e-Info Alkes dan PKRT (infoalkes.kemkes.go.id), which provides a permit-check (Cek Izin) search; the izin edar number (NIE) must appear on the product label.

Clinical evidence is required for class C and D devices and for new devices impacting human safety and health; it may take the form of a systematic literature study, clinical evidence on similar devices, or a clinical investigation. A clinical investigation is required where the manufacturer has no clinical evidence. Preclinical results (biocompatibility/biological evaluation) are required only for class C and D devices.

Clinical investigations of health supplies must comply with Cara Uji Klinik yang Baik (CUKB, device GCP) and obtain a clinical trial approval letter (surat persetujuan pelaksanaan uji klinik); trial organisers must register the trial. The CUKB for devices is set by the Minister.

In defined circumstances devices and PKRT may be imported without an izin edar through the special-route (jalur khusus) mechanism with the Minister's approval, for purposes of: healthcare services; research needs; government programmes; social service (bakti sosial); exhibitions; personal use; and other needs determined by the Minister. Personal-use and certain other imports (temporary import, re-import of exports, foreign-representative needs) may proceed without the Minister's approval via courier/postal services, passenger baggage etc.

In emergencies, disasters, extraordinary events (KLB), epidemics or health crises, health supplies may be circulated under an emergency use authorization (EUA) issued by the Minister (for devices) or the food-and-drug authority head (for drugs) within their respective mandates.

The izin edar holder of devices and PKRT must perform sampling and testing at least once during the validity period of the authorization; testing of samples is carried out by accredited laboratories, and sampling/testing activities are reported through the health information system integrated with the national health information system.

The izin edar holder must report potential shortages of health supplies to the Minister at the latest 6 months before the shortage occurs; the Ministry responds through accelerated izin edar and the special-route mechanism.

The izin edar holder must operate device vigilance ('vigilans': detection, assessment, understanding, communication, control and prevention of adverse effects or other problems related to device use) and report it to the Minister, through the health information system integrated with the national health information system, within deadlines set by the Minister. Health professionals and health facilities may report device adverse events (kejadian tidak diinginkan/KTD) to the Minister; the national reporting channel is the e-Watch Alat Kesehatan system, which also covers field safety corrective actions (FSCA).

Health supplies not meeting safety/benefit/quality standards or labelling requirements must be withdrawn from circulation by the izin edar holder and/or business operators, either on the order of the Minister (for devices) or on the operator's own initiative. Recall triggers include sampling/testing results, complaint verification, inspections, the rapid-alert system, an izin edar that expired without extension, and revoked izin edar or EUA. The recalling operator must document the recall and report it to the Minister through the integrated health information system; recall procedure (tata cara) for devices is set by the Minister.

Devices whose use requires the assistance of medical or health personnel may only be promoted and advertised in scientific media for medical and health personnel (media ilmiah untuk tenaga medis dan tenaga kesehatan). Promotion and advertising of any health supply must give objective, complete and non-misleading information on benefits, contraindications, side effects and usage precautions, and comply with advertising ethics; the promotion/advertising procedure for devices and PKRT is set by the Minister.

Applicants receive notification of the izin edar issuance or the digitally signed rejection letter by e-mail and SMS to the registered company contact, and download the license or rejection letter electronically via regalkes.kemkes.go.id. Applications failing safety/quality/benefit requirements receive a rejection letter; the paid PNBP fee is not refunded for rejected applications.