Medical device distribution in Indonesia
Only registered medical devices may be distributed in Indonesia, which means that the product has 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 Kemenkes Online Medical Device Registration platform unless exempted from registration. All medical devices and household health supplies (PKRT) that are in circulation (i.e., registered) in Indonesia as well as those that are exported are listed in the Medical Device & PKRT E-Report system. Registered medical devices can only be distributed by companies who have a medical device distributor license in Indonesia, known locally as a IDAK/SDAK.
Who can distribute medical devices in Indonesia?
- Only Indonesian companies that hold a valid IDAK (Izin Distribusi Alat Kesehatan) or Medical Device Distribution License (MDDL) or SDAK (Sertifikat Distribusi Alat Kesehatan) or Medical Device Distribution Certificate (MDDC) otherwise known as a Distributor License may distribute medical devices, in-vitro diagnostics (IVDs) and household health supplies (PKRT) in Indonesia.
- In Indonesia, it is important to remember that a medical device can only be 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. Only one Product License will be issued by the Ministry of Health to one IDAK/SDAK.
- Even though a company must have a valid IDAK/SDAK to distribute, this same company does not necessarily have to be the Product License Holder. In fact, it may be judicious to appoint an independent Local Authorized Representative (LAR) to register and import your medical device. This LAR will then act as your master distributor who will work alongside your final distribution channel partners to get your product to the end-user.
- What’s more, the LAR can also register your product for potential supply to the public healthcare system via the E-Catalogue (see below). This means you can maximize your distribution channels by having various channel partners available to you at any one time.
- Choosing to work with an LAR rather than directly with a distributor gives you real flexibility in your distribution strategy; you can adapt quickly to changes in the market by adding new distributors, increase transfer pricing as well as ensuring rigorous quality and compliance controls continue post-market.
- 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.
What are the requirements for distributing medical devices in Indonesia?
- Any company wishing to distribute medical devices, in-vitro diagnostics (IVDs) and household health supplies (PKRT) in Indonesia must have a valid valid IDAK (Izin Distribusi Alat Kesehatan) or Medical Device Distribution License (MDDL) or SDAK (Sertifikat Distribusi Alat Kesehatan) or Medical Device Distribution Certificate (MDDC) otherwise known as a distributor license. This also applies to any sub-distributors that are appointed.
Advertising rules
Advertising, communication and promotion of medical devices is a common part of a distribution contract, either falling to the manufacturer or the local distributor to undertake. In Indonesia, advertisements of medical devices require prior approval by the Ministry of Health. The advertisement must meet the rules in accordance with Health Law No. 36 of 2009, namely objective, honest or true, complete, not misleading, not excessive and clear.
Distributor’s duties and obligations
It is mandatory for distributors of medical devices and IVDs in Indonesia to:
- report Unexpected Events (UE), Field Safety Corrective Actions (FSCA) and Complaints through the Medical Device E-Watch system
- 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 a valid IDAK/SDAK distributor license
- distribute products in accordance with GDPMD standards.
How Andaman Medical can help with distributing medical devices in 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 sub-distributors. Our regulatory affairs specialists will help you to:
- register and import your medical device
- authorize your sub-distributors
- enroll your medical device for direct supply to public healthcare establishments via the e-Catalogue system, if desired
- ensure your product is correctly labelled
- facilitate customs clearance
- provide storage and warehousing for your products
- maintain post-market surveillance of your registered product
- liaise with your appointed sub-distributors concerning the mandatory reporting of Unexpected Events and Field Safety Corrective Actions.