Medical device importation to Indonesia
Only registered medical devices may be imported into Indonesia, which means only products that have been issued with a Distribution Approval Number or NIE (Nomor Izin Edar) otherwise known as the Product Approval License from the Ministry of Health via the Online Medical Device Registration platform (hereafter called the Kemenkes system) unless exempted from registration (see below). All medical devices and household health supplies (PKRT) that are in circulation in Indonesia as well as those that are exported are listed in the Medical Device & PKRT E-Report system.
What are the requirements for importing medical devices into Indonesia?
- Any company wishing to import products into Indonesia must first register through the Online Single Submission (OSS) system to obtain a Business Identification Number (NIB) which serves as a basic Import License. The NIB replaces the previously issued API or importer identification number as well as the TDP or company registration certificate.
- However, to import medical devices, only a product license holder (NIE) may do so according to Article 3 of the Ministry of Health Regulation no. 60 of 2017 entitled “Supervision of Trade in Imported Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies”
- The NIE is issued only once the medical device has been registered via the Kemenkes platform
- Any company wishing to import medical devices and in-vitro diagnostics (IVDs) into Indonesia must have a valid SDAK (Sertifikat Distribusi Alat Kesehatan) or Medical Device Distribution Certificate (MDDC),nowadays more well known as IDAK (Izin Distribusi Alat Kesehatan) or Medical Device Distribution License (MDDL) otherwise known as a distributor license. This is also a requirement in order to register the product in the first place.
- Please note that only local Indonesian companies can apply for the NIB and the IDAK (via the OSS) and hence register and import medical devices
- A medical device can only registered by one IDAK/SDAK (distributor license holder) at a time. Multiple registrations of medical devices with different companies or distributor license holders are not allowed in Indonesia. It is vital to choose the correct partner as they are responsible for registering, importing and distributing your medical device to your customers or channel partners.
Are there any exemptions or exclusions?
- Certain products may be imported using Special Access Routes (see below).
- Products that are temporarily imported for testing purposes in order to obtain registration licenses and are then re-exported do not require an import license.
- However, any products that are imported for export trade purposes must still obtain an import license
- Certificates of Free Sale will not be issued for medical devices imported from (or exported to) countries which do not have diplomatic ties with Indonesia such as Israel.
Special Access Routes for importing medical devices into Indonesia
Two Special Access Routes exist in Indonesia for importing medical devices which are exempt from registration with the Ministry of Health, however the SAS permit must be obtained from the MoH before importing:
1. SAS Donations only for the needs of:
- health services
- government health programs
- research and development and/or
- prevention of outbreaks, epidemics, or disasters (e.g., COVID19)
2. SAS Non-Donations only for the needs of:
- special use at the request of a doctor
- government health programs
- research and development
- education and training and/or
- national scale health exhibition.
- NB: You must re-export any unused products at the end of the research and development, education or training, or exhibition
Importers duties and obligations
It is mandatory for importers of medical devices and IVDs to Indonesia to:
- maintain a valid Importer's License and implement GDPMD standards
- maintain a Quality Management System (QMS) – periodically the MoH will audit production and distribution facilities’ compliance to the Quality Management System
- maintain a record of all imports (and exports) and submit distribution records through the Medical Device E-Report system to ensure full traceability of the whereabouts of a medical device in case of recall
- maintain records of and report any Unexpected Events (UE), Field Safety Corrective Actions (FSCA) and Complaints through the Medical Device E-Watch system to the Ministry of Health.
How Andaman Medical can help with importing medical devices to Indonesia:
We are a fully licensed Local Authorized Representative, Importer and Distributor of medical devices, in-vitro diagnostics, medical equipment, software as a medical device (SaMD) and household health supplies (PKRT) in Indonesia. We remain independent from any final distribution channel partner you choose to appoint ensuring you freedom in your distribution strategy, you may even appoint multiple distributors. Our regulatory affairs specialists will help you to:
- register and import your medical device
- enroll your medical device for direct supply to public healthcare establishments via the e-Catalogue system, if desired
- ensure your product is correctly labelled / relabelling
- facilitate customs clearance
- provide storage and warehousing for your products
- maintain post-market surveillance of your registered product
- liaise with your appointed distributors concerning the mandatory reporting of Unexpected Events and Field Safety Corrective Actions.
We also offer additional support services such as:
- Online regulatory training
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market.