In order to distribute medical devices and adhere to the regulations set forth by the Ministry of Health (MoH) in Indonesia, medical device distributors must possess a valid distribution license. Previously this distribution license was known as IPAK (Izin Penyalur Alat Kesehatan). However, in accordance with the latest regulations, namely PP No. 5/2021 and Ministry of Health Number 14/2021 on Medical Device Distributors concerning risk-based business licensing, Indonesia’s MoH has since updated the distributor license to IDAK (Izin Distributor Alat Kesehatan). On January 23, 2024, Indonesia’s MoH published an announcement emphasizing the compliance of medical device distributors in transitioning from the previous medical device distributor license, IPAK, to the updated IDAK license, as IPAK will soon be deemed invalid for use.
IDAK vs. IPAK
The IPAK, or Izin Penyalur Alat Kesehatan, was the previous license for Medical Device Distributors in Indonesia. It functioned as a regulatory measure to ensure distributors complied with quality and safety standards for the medical devices they supplied.
The key differences between IDAK and IPAK lies in the following:
- Validity periods: Unlike IPAK licenses, which did not have a specified validity period as indicated in the previously repealed 1191/MENKES/PER/VIII/2010, IDAK licenses are valid for five years and require renewal upon expiration.
- Application process: IDAK licenses are streamlined through an online platform. Applicants now make submissions electronically on the Online Single Submission (OSS) website that is integrated with Indonesian Ministry of Health's website. The procedures can be seen at IDAK Application User Guide.
This updated regulation in IDAK aims to ensure better control over the medical device supply chain within Indonesia and a improve upon the licensing process compared to the previous system. Materials related to fulfilling IDAK requirements can be accessed at IDAK COMPLIANCE MATERIALS.
Impact on Medical Device Distributors
The Announcement on Medical Device Distributor License Update (IDAK) - FR.03.06/E.V/0373/2024 from MoH encourages the distributors to comply transition to IDAK, with the following outlined:
- Existing IPAK holders are required to assess their transition unto IDAK license, which is also done through the OSS website;
- Medical Device Distributors must have their Business License Number registered under KBLI 46691 (Wholesale of Laboratory Equipment, Pharmaceutical and Medical Equipment for Humans);
- Distributors should possess a Good Distribution Practice of Medical Devices (GDPMD/CDAKB) Certificate according to regulation of the Ministry of Health Number 14/2021 on Medical Device Distributors to ensure compliance with GDPMD standards.
Solutions for Foreign Medical Device Manufacturers
Since having an IDAK is essential for distributing medical devices, foreign manufacturers or distributors seeking to distribute their medical devices in Indonesia's market, may consider the following option:
- Establishing a local subsidiary: This option allows foreign manufacturers to have direct control over distribution in Indonesia. However, it requires a significant investment to set up, maintain, and requires registering IDAK for the local legal entity.
- Appointing a local distributor with an IDAK: Foreign manufacturers can partner with a qualified local distributor holding an IDAK license. This option eliminates the need for a local subsidiary but necessitates a strong partnership agreement with the distributor.
- Utilizing an independent third-party registration service provider: Foreign manufacturers can engage a qualified service provider to handle the registration process and partner with a local IDAK-registered distributor on their behalf. This option offers convenience but requires careful selection of a reputable service provider.
Conclusion
The transition from IPAK to IDAK signifies changes in Indonesia's medical device distribution regulations. Key points to remember include:
- IPAK will no longer be valid to use, in which IDAK stands in its place as the accepted Medical Device Distributor License in Indonesia.
- Existing IPAK holders must assess the transition to IDAK license, where registration is done through OSS website.
- Medical Device Distributors must have their Business License Number for KBLI 46691, along with a GDPMD/CDAKB Certificate.
- Foreign medical device manufacturers have options to establish a local subsidiary, partner with a local IDAK distributor, or utilize a third-party service provider.
Complying with Indonesian medical device regulations is crucial for ensuring the safety and efficacy of medical devices available to patients. As an IDAK-registered and GDPMD/CDAKB Certified company, Qualtech Consulting Corporation possesses extensive expertise in navigating the regulatory landscape and assisting medical device distributors with IDAK compliance.
Start your Regulatory Compliance Journey with us!
Medical device distributors and manufacturers seeking guidance on IDAK compliance are encouraged to contact Qualtech Consulting Corporation. Our team of specialists can provide comprehensive support throughout the process, ensuring a smooth transition under the new regulations.
Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.
Contact us today and unlock your business potential in Indonesia’s market!
References:
Announcement on Medical Device Distributor License Update (IDAK) - FR.03.06/E.V/0373/2024