Withdrawal, Destruction and Administrative Sanctions for Non-Compliant Medical Devices

1. Key takeaways

Indonesian law treats a non-conforming device as a product that must leave the market, and in defined cases be physically destroyed. The key rules are: withdrawal is mandatory whenever the marketing authorisation holder and/or operators involved in production or distribution fail to meet the standards and/or requirements for safety, efficacy/benefit, quality and labelling (PP 28/2024); and six categories of devices must be destroyed.

• The six destruction categories. Devices must be destroyed when they are: ① non-conforming with standards and/or requirements; ② without a marketing authorisation; ③ subject to a revoked marketing authorisation; ④ under an expired marketing authorisation with no extension processed; ⑤ expired; or ⑥ involved in health-sector crimes. Destruction must weigh both the impact on human health and environmental protection.
• Administrative sanctions escalate in three steps. The sequence runs: ① written warning (peringatan tertulis); ② suspension of activities (penghentian sementara kegiatan); ③ revocation of the marketing authorisation (pencabutan izin edar). Triggering situations include failure to fulfil quality and safety assurance obligations from production through distribution, failure to conduct vigilance and pharmacovigilance, and failure to withdraw non-conforming products as required.
• Permenkes 5/2026 closes the loop. The new regulation restates the principle that products may not circulate without a marketing authorisation: goods sold without a licence must be withdrawn, under Articles 89-90 and Article 117. Companies should therefore secure the certificate before the goods arrive at port; otherwise the shipment itself can become an object of destruction.
• Certificates also die for non-technical reasons. Four administrative paths invalidate a certificate independently of product quality: expiry of the certificate itself, expiry of the production licence, expiry of the IDAK, and expiry or non-renewal of the letter of authorisation (LoA), plus revocation of the certificate. These invalidation circumstances were established by Permenkes 62/2017, Article 25, and are now carried forward by Permenkes 5/2026.

2. Legal basis

The withdrawal, destruction and sanction regime sits primarily in PP 28/2024, which defines when a device must be pulled from circulation, enumerates the six destruction categories and sets the three-step administrative sanction ladder. Permenkes No. 5/2026, Articles 89-90 and Article 117, carries the no-circulation-without-licence principle into the current medical supplies regulation and requires unlicensed products on the market to be withdrawn. Permenkes No. 62/2017, Article 25, historically fixed the invalidation circumstances for registration certificates, and those circumstances now continue under Permenkes 5/2026. Read together, the three instruments create a single logic chain: a product that loses conformity, loses its licence, or never had one must be withdrawn; defined products must then be destroyed; and the responsible entity faces sanctions that escalate from a written warning to suspension of activities to revocation of the marketing authorisation.

3. Expert insights

Conformity is a moving target, and labelling is where companies most often lose it. The withdrawal trigger in PP 28/2024 covers failures against safety, efficacy/benefit, quality and labelling standards and/or requirements. Of these, safety and quality failures usually announce themselves through complaints or testing, but labelling drifts silently: after registration, a company that redesigns its label on its own authority, for example by reverting to foreign-language artwork or adding claims that were never approved, falls straight into the non-conformity with labelling requirements and thereby triggers the withdrawal obligation. The product may be technically identical and perfectly safe, yet still be a product that must leave the market.

The destruction list is broader than companies assume. Most firms expect destruction to attach only to defective goods, but the six categories also cover products that are simply unlicensed, products whose licence was revoked, products whose licence expired without extension, and products that have passed their expiry date. This is why the timing rule in Permenkes 5/2026 matters commercially: obtaining the certificate before the goods arrive at port is not paperwork caution, it is asset protection, because a shipment without a marketing authorisation at the wrong moment is itself one of the six destruction categories.

The sanction ladder punishes process failures, not only product failures. The listed triggers include failing to assure quality and safety across production and distribution, failing to conduct vigilance and pharmacovigilance, and failing to withdraw non-conforming products. A company can hold a flawless product record and still climb the ladder if its post-market processes collapse. The escalation from written warning to suspension to revocation also means that revocation is rarely a first response: it is the end state of ignoring earlier steps, which gives diligent companies a real chance to correct course at the warning stage.

4. Practical recommendations

• Manage safety, quality and labelling conformity as dynamic items, not one-off checks. Assign ownership for each of the four conformity dimensions across the life of the certificate, so that drift is caught before it becomes a withdrawal trigger.
• Freeze label changes behind an internal approval gate. No artwork, language or claim change should ship without confirming it stays within the approved registration content, since unapproved relabelling directly constitutes non-conformity with labelling requirements.
• Secure the marketing authorisation before goods arrive at port. Sequence shipments against the certificate timeline, because goods without a licence at arrival can become destruction objects under the six-category regime.
• Run a calendar on the four non-technical certificate killers. Track certificate expiry, production licence expiry, IDAK expiry and LoA expiry or renewal dates together, since any single lapse invalidates the certificate independently of product performance.
• Map your processes against the sanction triggers annually. Confirm that quality and safety assurance from production to distribution, vigilance and pharmacovigilance, and withdrawal procedures are all demonstrably operating, so the escalation ladder never finds an opening.

5. Verification checklist

• □ PP No. 28/2024 confirmed: withdrawal trigger, six destruction categories, three-step administrative sanctions (verified 26 October 2026)
• □ Permenkes No. 5/2026, Articles 89-90 and Article 117 confirmed: no circulation without marketing authorisation; unlicensed products withdrawn
• □ Permenkes No. 62/2017, Article 25 confirmed: certificate invalidation circumstances, now carried by Permenkes 5/2026
• □ Six destruction categories mapped against current product portfolio
• □ Four non-technical invalidation paths (certificate, production licence, IDAK, LoA) entered in the compliance calendar
• □ Labelling change-control gate in place to prevent unapproved relabelling

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