Refurbished Medical Devices in Indonesia: What the New Import Rule Actually Permits

This guide is for importers and distributors considering refurbished medical devices for the Indonesian market, foreign remanufacturers assessing whether Indonesia has reopened to them, and hospital procurement teams evaluating pre-owned equipment. After reading it, you will know exactly what Indonesia’s current regulation permits, what it leaves undecided, and what medical device registration in Indonesia now requires before you commit capital to a shipment.

The regulatory position on refurbished medical devices in Indonesia changed on 4 May 2026. Peraturan Menteri Kesehatan Nomor 5 Tahun 2026 revoked the instruments that previously governed medical device import trade supervision and marketing authorization, and at Pasal 58 ayat (6) it introduced an express, standalone provision permitting import of medical devices in a non-new condition. In our experience handling import files at the port, this is where most non-new shipments actually run into trouble: not at the ministry’s policy desk, but at the customs gate, when the harmonised system code and business identification number on the declaration do not line up exactly with the equipment’s registration particulars. Pasal 58 ayat (6) does nothing to protect against that mismatch, and no summary of the regulation we have seen mentions it.

Can Refurbished Medical Devices Be Legally Imported Into Indonesia?

Short answer: Yes, in principle, but only for “certain purposes” (tujuan tertentu) that Permenkes 5/2026 does not define, and only after the device separately obtains an izin edar (marketing authorization), which Pasal 58 ayat (6) does not waive. The provision replaces an earlier position where the framework had no clear route at all for non-new equipment. It does not replace the need to obtain the Ministry’s written position on your specific purpose before shipping.

What Changed, and Why the Old “Flat Ban” Description No Longer Holds

Indonesia’s medical device import framework was, until 4 May 2026, built around new product placed on the market by an authorised representative. Used equipment did not fit that pathway cleanly, and enquiries about refurbished medical devices were routinely met with a general prohibition.

Permenkes 5/2026, signed 17 April 2026 and promulgated 4 May 2026, changed that starting point. Pasal 58 ayat (6) states that import of medical devices in a non-new condition may be carried out for certain purposes after fulfilment of safety, benefit, and quality requirements in accordance with statutory provisions. That is a real change of position. It is also, on close reading, considerably less than an operating pathway.

What Pasal 58 Ayat (6) Says, and What It Deliberately Does Not Say

Three features of the text matter for anyone building a commercial plan around it.

• The permission is general as to device class. Pasal 55 divides devices into risk classes A through D, and ayat (6) does not restrict itself to low-risk classes, even though commercial interest in the secondary market concentrates in high-value class C and D imaging and therapeutic equipment.
• The condition is the ordinary standard, not a special one. “Safety, benefit, and quality” is the same three-part formula the regulation applies throughout, at Pasal 2, Pasal 14, Pasal 50, and Pasal 57. It is not a heightened test, and it does not require a specific safety test. That is a claim we have seen repeated in market summaries, and the text itself does not support it.
• The permission defers to other legislation it does not name. The closing words point to “statutory provisions” generally, and the substance sits outside Pasal 58 ayat (6) itself.

That deferral is the crux of the problem, because the two Permenkes instruments that most directly governed this ground, Permenkes No. 60/2017 on import trade supervision and Permenkes No. 62/2017 on marketing authorization, are both revoked by Permenkes 5/2026 at Pasal 125. Pasal 124 preserves existing implementing provisions so far as they do not conflict with the new regulation, but it does not revive instruments that are expressly revoked.

The Four Gaps an Importer Has to Resolve Before Committing Capital

1. “Certain purposes” is undefined

Ayat (6) permits non-new import for tujuan tertentu without listing what qualifies. Contrast this with Pasal 62 ayat (5), the special access scheme, which enumerates its permitted purposes explicitly: health services, research, government programmes, social work, exhibitions, personal use, and other needs the Minister determines. Ayat (6) contains no equivalent list, which means ordinary commercial resale is neither confirmed nor excluded by the text.

2. No implementing guidance is delegated

Pasal 58 ayat (7) delegates procedure to the Minister, but only for the import certificate referred to in ayat (5). There is no matching delegation for ayat (6). The instrument that would explain how to actually use the provision is not identified on the face of the regulation.

3. The legislation it defers to is mid-replacement

The obvious candidates for the “statutory provisions” ayat (6) references, Permenkes 60/2017 and Permenkes 62/2017, are the same two instruments Permenkes 5/2026 revokes. The framework a non-new import is supposed to comply with is, for the moment, in transition.

4. The izin edar requirement is not displaced

This carries the largest commercial consequence. Pasal 58 ayat (4) requires an izin edar for any imported medical device, new or non-new. Ayat (6) adds a condition for non-new devices; it does not state an exemption from ayat (4). Reading ayat (6) as a substitute for the izin edar requirement would mean used equipment enters more easily than new equipment, which runs against the coherent purpose of the regulation. Two further provisions make the cost of guessing wrong concrete. Pasal 89 ayat (1) huruf b requires destruction of health supplies circulating without an izin edar. Pasal 51 ayat (1) huruf b permits revocation of an izin edar where the circulating product’s specification does not match the approved specification, a real risk for refurbished equipment whose post-refurbishment configuration may differ from what was originally approved.

Where the Special Access Scheme (Pasal 62) Fits Instead

If your purpose is not commercial resale, Pasal 62 may be the more certain route, because it has defined purposes where Pasal 58 ayat (6) does not.

Pasal 62 ayat (6) exempts personal use and “other needs” from the approval requirement, and ayat (8) identifies those other needs as temporary import, re-import of exported goods, and requirements of foreign missions.

Import License Indonesia: The Procedural Layer Around Ayat (6)

Whichever route applies, the procedural architecture around it is unforgiving on detail. Import under Permenkes 5/2026 runs through an electronic system integrated with Indonesia’s National Single Window (Pasal 58 ayat 1). Pasal 60 provides that the import certificate, import approval, and izin edar function either as customs complementary documents checked inside the customs area, or as import requirement documents checked outside it, with verification run against the taxpayer or business identification number, the izin edar number and date, and the harmonised system code. Pasal 61 lets the Ministry or the food and drug authority decide which health supplies get checked at the border versus post-border.

This is a document-reconciliation exercise, not a policy question, and it is exactly where a valid import license Indonesia application can still stall at the port if the harmonised system code or business identification number on the customs declaration does not match the underlying authorisation data.

Radiation-Emitting Equipment: BAPETEN Still Applies in Full

Nothing in Permenkes 5/2026 touches the separate regime for ionising-radiation equipment. Any refurbished CT scanner, C-arm, or radiotherapy unit still needs a BAPETEN radiation safety inspection before clinical use, and the receiving facility still needs its own BAPETEN facility license and certified shielding, regardless of the equipment’s history or purpose of import. Treat this as a separate, parallel project rather than a step inside the Pasal 58 ayat (6) process. Our team handles it through our radiation medical device registration service precisely because the two tracks run on different timelines and different regulators.

Timing: The Transition Window Closes 4 May 2027

Permenkes 5/2026 took effect on promulgation, 4 May 2026. Pasal 122 gives arrangements for the conduct of health supplies one year from promulgation to come into conformity, meaning 4 May 2027. The permission at ayat (6) is available now, but the framework around it, including the legislation it defers to, is still being replaced. A Ministry position obtained today may be superseded before that date, so plan to revisit any approval you secure during this window.

What to Confirm Before You Ship

• Get the Ministry’s written position on whether your intended purpose falls within tujuan tertentu under Pasal 58 ayat (6). This is the threshold question, and the regulation does not answer it for you.
• Plan on needing an izin edar unless the Ministry states otherwise in writing, given the destruction consequence at Pasal 89.
• Check whether the refurbished configuration differs from the specification the device is or would be authorised against, and resolve any divergence before import, not after, given the revocation risk at Pasal 51.
• Confirm which legislation the Ministry currently treats as supplying the safety, benefit, and quality requirement for a non-new device, in writing, while Permenkes 60/2017 and 62/2017 are being replaced.
• If the equipment emits ionising radiation, run the BAPETEN process as a separate, parallel workstream.
• If your purpose is donation, research, exhibition, temporary entry, or return after repair, look to Pasal 62 before Pasal 58 ayat (6); it is the more clearly defined route.

How Medical Device Registration Services in Indonesia Reduce This Exposure

A regulation with an undefined key term and a citation to legislation mid-replacement is not something to navigate from the text alone. Our layanan registrasi alat kesehatan di Indonesia are built for exactly this kind of transition period: we hold the Ministry’s written position on file, track which instrument currently governs your device class as Permenkes 5/2026’s one-year window plays out, run your medical device product registration alongside the ayat (6) purpose determination, and reconcile your import documentation against Pasal 60’s data-matching requirements before your shipment reaches the port. For background on how distribution licensing sits alongside registration under the current framework, see our related article on IDAK and CDAKB compliance for medical device distribution in Indonesia.

Moving Forward on Refurbished Medical Devices

The good news is that Indonesia’s door to refurbished medical devices is open in a way it simply wasn’t before 4 May 2026. That’s a meaningful shift, and importers who move early, with the right documentation and a written Ministry position in hand, are in a strong position to build a durable presence in this market before the transition window closes. The uncertainty in Pasal 58 ayat (6) is a gap to manage, not a wall to wait out.

If you’re weighing a refurbished equipment shipment, talk to our Medical Device and IVD Registration team first. We’ll help you get the Ministry’s purpose determination in writing and confirm your import route under Pasal 58(6) before anything ships.