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Indonesia: Draft of Government Regulations concerning the Implementation of Law No. 17 of 2023 concerning Health in Indonesia

A draft of Government Regulations pertaining to the Implementation of Law No. 17 of 2023 concerning Health was uploaded on the Ministry of Health of Indonesia official website. This regulation was derived from Law No. 17 of 2023, in which one of the clauses mentioned that the further implementation of the law will be regulated under the Government Regulations or Peraturan Pemerintah (PP). This draft consists of 13 Chapters with total of 1166 articles, as follows:

  1. CHAPTER I: General Provisions
  2. CHAPTER II: Health Efforts
  3. CHAPTER III: Management of Medical and Health Personnel
  4. CHAPTER IV: Health Service Facilities
  5. CHAPTER V: Pharmaceuticals, Medical Devices and Health Supplies
  6. CHAPTER VI: Health Information System
  7. CHAPTER VII: Implementation of Health Technology
  8. CHAPTER VIII: Management of Extraordinary Events and Outbreaks
  9. CHAPTER IX: Health Funding
  10. CHAPTER X: Society Participation
  11. CHAPTER XI: Guidance and Supervision
  12. CHAPTER XII: Transitional Provisions
  13. CHAPTER XII: Closure Provisions

Some of the highlighted articles that could potentially affect the medical devices manufacturers, are as follows:

  • In Article 414 point (1), the regulation stated that in fulfilling standards and requirements, business actors in the fields of pharmaceutical preparations, medical devices, and household supply shall carry out efforts to ensure product quality since production activities to distribution.


Quality assurance activity shall be carried out to guarantee that quality of production and distribution of the products meet the requirements safety, efficacy/benefits, and quality.

  • Article 931

In order to enhance independence related with the provisions of pharmaceutical preparations and medical devices, the Central Government, Regional Government, and Health Service Facilities are obliged to carry out procurement of domestic pharmaceutical preparations and medical devices.

  • Article 933

In order to support the production of domestic pharmaceutical preparations and medical devices, the Central and Regional Governments shall provide incentives to local pharmaceutical and medical devices industries and business actors that seeks to carry out the implementation of resiliency in the pharmaceutical preparations and medical devices provision.

  • Article 902

Under point (1), based on Article 900, the Central and Regional Government will be responsible for the planning, provision, and distribution of health supplies. Therefore, during the planning of the health supplies, selection process will be applicable for the provision of pharmaceutical preparation, medical devices, and other household products.

Under point (2), it is regulated that the Minister shall prepare a formulary and list of Medical Devices essential for quality and cost control of health services.

Under point (3), the selection as intended in point (1) refers to the formulary and list of essential Medical Devices determined by the Minister.

Under point (4), the formulary and list of essential Medical Devices as intended in paragraph (2) is reviewed and revised no later than every 2 (two) years in accordance with the development in public needs and technology.

Explanation: The development shall be carried out in accordance with the development in science and technology, shall provide room for improvement to the Formulary National, and shall increase the speed of access within use and delivery of drugs to patients adapted to the competence of health workers and level of existing health facilities.

The draft government regulation (in Bahasa Indonesia) can be accessed here.

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