Indonesia Medical Device Regulations: The Four-Tier Legal Framework

1. Key takeaways

Indonesian device regulation is currently organised in four layers. Knowing which layer answers which question, and which instrument has repealed which, is the foundation for every registration argument a manufacturer or licence holder will need to make.

• Layer one, the law: UU 17/2023, the Health Law. Layer two, the government regulation: PP 28/2024, issued and effective on 26 July 2024, which replaced approximately 31 government regulations and presidential regulations that preceded it.
• Layer three, the ministry regulations: Permenkes 5/2026 on Medical Supplies, signed on 17 April 2026 and effective on 4 May 2026, together with Permenkes 11/2025 (dated 3 October 2025, containing 40 articles plus 1 appendix).
• Layer four: circulars (Surat Edaran) and technical guidance issued by Ditjen Farmalkes.
• Permenkes 5/2026, in its Article 125, expressly repeals Permenkes 62/2017. A large body of Indonesian registration articles still circulating on the Chinese-language internet continues to cite 62/2017, including its Article 24 validity period and Article 26 renewal window. Those provisions are now historical, and following them will create problems.
• Permenkes 5/2026 simultaneously consolidated and replaced a cumulative total of 40 Ministry of Health regulations accumulated since 1972.
• Permenkes 11/2025 defines the business activity standards and the product or service standards under the risk-based business licensing regime (OSS-RBA). Its Appendix 3 is the service standard for marketing authorisation of imported devices, specifying item by item the required documents, the A to D classification, the notification list, the evaluation time limits and the renewal timing. In practical terms, Permenkes 11/2025 functions as the process and the clock, while Permenkes 5/2026 functions as the substantive law; both must be read together, because neither answers every question alone.
• The four layers answer different kinds of questions. The law establishes that licensing is required, the government regulation consolidates the licensing regime, the ministry regulations carry the technical substance, and the circulars adjust operational detail. Arguments that skip a layer, for example citing a circular without its statutory anchor, are fragile when challenged.

2. Legal basis

The hierarchy runs from the law to the implementing instruments. UU 17/2023 is the statute. PP 28/2024, promulgated and effective on 26 July 2024, is the government regulation layer. At the ministry level, Permenkes 5/2026 on Medical Supplies was signed on 17 April 2026 and entered into force on 4 May 2026, while Permenkes 11/2025, dated 3 October 2025, contains 40 articles plus 1 appendix. Below the ministry regulations sit the circulars and technical guidance of Ditjen Farmalkes. The practical mapping is that Permenkes 5/2026 supplies the substantive rules and Permenkes 11/2025 supplies the process and the clock: substantive obligations should be argued from Permenkes 5/2026, and procedural time limits and document standards should be argued from Appendix 3 of Permenkes 11/2025, with circulars consulted thereafter. When citing any requirement in a dossier, a response to a deficiency letter, or an internal standard operating procedure, the citation should land on a specific article number in the correct instrument rather than on a summary of what the rule is understood to say. This discipline matters most at moments of dispute, such as responding to a deficiency letter or defending a filing position in an audit, where a generalised paraphrase carries no weight against a documented article citation.

3. Expert insights

The transition period is where most practical risk now sits. Permenkes 62/2017 cannot be cited as a current basis, because Article 125 of Permenkes 5/2026 expressly repeals it. Yet a substantial share of Indonesian registration content still in circulation treats the old instrument as the governing text, including its provisions on the validity period of the licence and the window for renewal. Any dossier, contract clause or compliance manual that still relies on those provisions is relying on historical text. At the same time, Article 37 of Permenkes 11/2025 leaves room for system transition arrangements, which means that the way the Regalkes system actually executes a requirement may differ from the written provision for a period of time. Before any submission, the operative guidance should be taken from the current prompts in the system and from official circulars, not from either the old repealed regulation or a literal reading of the new text alone. Companies that document the source of each filing requirement, with the instrument, the article and the access date, resolve transition-period discrepancies far faster than companies that reconstruct their reasoning from memory when a reviewer questions a choice.

4. Practical recommendations

• Maintain a regulation register and review it quarterly. Focus on three variables: whether the technical guidance under Permenkes 5/2026 has been issued, how Permenkes 11/2025 is actually being implemented in Regalkes, and whether Kemenkes circulars have added or removed items from the document lists.
• Anchor every regulatory position to a specific article number: substantive obligations from Permenkes 5/2026, process time limits from Appendix 3 of Permenkes 11/2025, and only then the circulars.
• Keep the register in a single controlled location so that one update propagates across the company, avoiding divergent versions of the rules held separately by sales, regulatory and logistics teams that act on inconsistent assumptions.
• During the transition period, verify each submission against the current system prompts in Regalkes and the latest official circulars before filing, and record the date of that verification in the dossier.
• Audit all existing templates, training materials and customer-facing documents for references to Permenkes 62/2017 and replace them, since citations to a repealed instrument undermine the credibility of any regulatory position.

5. Verification checklist

• □ UU No. 17/2023.
• □ PP No. 28/2024 (26 July 2024).
• □ Permenkes No. 5/2026 (signed 17 April 2026, effective 4 May 2026), Articles 41-42, 50-51, 55, 58, 89-90, 96, 101, 104, 117 and 125.
• □ Permenkes No. 11/2025 (3 October 2025), Article 37 and Appendix 3.
• □ Permenkes No. 4/2014 (CDAKB), Article 2.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Indonesia. Our team prepares dossiers to ASEAN CSDT structure, manages AKL/AKL-I submissions with Kemenkes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com