Government Streamlines Medical Device Bureaucracy, Businesses Required to Update Data

The Ministry of Health has officially established regulatory transformation through the implementation of an indefinite validity period for Medical Device Distribution Certificates (IDAK). This step is a concrete implementation of Government Regulation (PP) Number 28 of 2024, which aims to reduce bureaucracy and repetitive administrative burdens for medical device distributors throughout Indonesia. This policy is taken to eliminate obstacles in the medical supply chain, which has often been hampered by routine permit extension processes every five years. With the now permanent permit status, the stability of the availability of medical devices in medical facilities is expected to be more guaranteed and efficient. Although administration is simplified, the government emphasizes that this ‘lifetime’ status is not absolute without supervision. Businesses are required to remain proactive in independently updating data through the Ministry of Health’s integrated system. Jihan Luthfiyah, Quality Site Management at Naramedic, stated that this ease brings new responsibilities for industry players in maintaining operational standards. “The implementation of a lifetime IDAK is a breath of fresh air for industrial efficiency. However, the company’s responsibility now shifts to the consistency of maintaining standards. Independent data updates in the Ministry of Health’s system become a mandatory step so that the company’s legality remains well integrated,” said Jihan in a statement on Friday (May 15, 2026). She also emphasized that this lifetime status does not mean that businesses can neglect changes in the company’s internal structure. “It is important to understand that a lifetime IDAK does not mean that the reporting process is completely finished. If there are fundamental changes such as the addition or reduction of medical device groups, changes in the Technical Responsible Person (PJT), to changes in the office or warehouse address, businesses are required to submit a change of IDAK. The government must still receive the latest information because the validity of the permit depends on the suitability of the data on the ground with the data recorded in the system,” added Jihan. To ensure that the permit status remains valid and avoid sanctions for revocation, medical device companies must pay attention to the following three crucial points: The government warns that the simplification of regulations is balanced with stricter sanctions. Permanent permits can be revoked at any time if violations of technical standards, deviations in distribution, or if the company no longer carries out actual business activities are found. This transition is expected to not only reduce company operational costs but also accelerate public access to quality technology and medical devices throughout the country. (H-2)