Indonesia’s Government Issued a New Regulation Pertaining to Health
Indonesia’s government has officially issued Law No. 17 of 2023 concerning Health which comes into effect on 8 August 2023. At the time this new regulation came into force, the previous Law No. 36 of 2009 concerning Health was revoked and declared invalid.
In general, Law No. 17 of 2023 covers the rights, obligations and responsibilities of the central and local government, health administration, health service facilities, and other health related sectors including the provision of health supplies, handling of outbreaks and other extraordinary events, synchronization of health system, community participation to achieve the highest degree of health up to the surveillance, investigation, and criminal provisions of any misconduct.
Compared to the previous regulation, there are a few revisions pertaining to the medical devices’ definition, general criteria, and sanction as follows:
- Medical device definition:
In this regulation, the medical device is described as an instrument, apparatus, machine, equipment, implant, in vitro reagent and calibrator, software, as well as materials that are used in humans for medical purposes and do not achieve primary work through pharmacological, immunological, or metabolic processes. According to Part 22 Article 138 of this regulation, pharmaceutical preparations, medical devices, and household supplies must be safe, beneficial, have good quality, affordable and able to meet the provisions of halal product assurance in accordance with the provisions of laws and regulations.
- General criteria:
Any entities who produce and/or distributes pharmaceutical preparations, medical devices, and household supplies must comply with the business license of the Central Government or Regional Government in accordance with their authority based on norms, standards, procedures, and criteria of laws and regulations. Those who have obtained a business license and proven not to meet the requirements for safety, efficacy/usefulness, and quality are subjected to administrative sanctions in accordance with the provisions of laws and regulations in the field of business licensing.
Any entities who produce or distributes Pharmaceutical Preparations and/or Medical Devices that do not meet the standards and/or requirements for safety, efficacy/usefulness, and quality will be punished with a maximum imprisonment of 12 (twelve) years or a maximum fine of Rp5,000,000,000 (five billion rupiah).
The newly issued regulation can be accessed here (in Bahasa Indonesia).
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