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February 16, 2025

Approximately 5 minutes

Medical Device License Amendment in Indonesia: Changes, Renewal, and Halal Compliance

Medical Device License Amendment in Indonesia: Changes, Renewal, and Halal Compliance

Maintaining market access for medical devices in Indonesia requires adherence to the Ministry of Health (MoH) regulations regarding license maintenance. This includes mandatory renewal every five years, obtaining approval for product changes via amendments, and ensuring compliance with evolving Halal requirements.

Acceptable License Amendments

Changes to an approved medical device require an amendment to the existing license (NIE) only if they are classified as minor administrative or design adjustments. All other significant changes necessitate submitting a new registration application.

Changes permitted under the Decree of Ministry of Health's No. 62 /2017 (article no. 30) include:

  • Packaging: Dimension and size changes.
  • Labeling: Content modifications.
  • Product Specifications: Changes to product codes, product numbers, and some product sizes.
  • Stability: Adjustments to product stability (temperature and expiry).
  • Administrative: Changes to distributor(s) or Tax ID number.

The fee for a license amendment is IDR 1,000,000 (approx. US$65-70), and the typical approval timeline is within 3 months.

License Renewal Process

Product licenses are generally valid for up to 5 years and must be renewed to maintain legal distribution.

  • Submission Deadline: Renewal applications should be submitted at least 9 months before the expiration date.
  • Distribution Reporting: As part of the renewal process, distribution activity data must be submitted through the E-Report system.
  • Fees: The renewal fee is IDR 1,000,000 (approx. US$65-70) per product.
  • Combined Application: A license renewal can be combined with a license amendment in a single application for a government fee of IDR 1,500,000. Combined processes are typically approved faster, often within 10-15 working days.

Evolving Halal Requirements

Manufacturers must monitor and comply with Indonesia's evolving Halal product requirements, which are crucial for market access.

  • General Principle: Products containing animal, plant, microbe, or process material must undergo Halal certification and bear the “HALAL” logo.
  • Non-Halal Products: Products that do not meet Halal standards must be appropriately labeled as “Non-Halal Product.”
  • Current Guidance: For many common medical devices that do not contain and have not been contaminated by animal materials, Halal certification may not be required immediately, but manufacturers must stay informed to adjust labeling when official regulations are fully implemented. Specific products, like porcine heart valves, are obviously Non-Halal and must be labeled as such.

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Questions & Answers (5)

T
Guest

Our Class C device is currently listed in E-Katalog Version 6. We are initiating a license amendment to add a new manufacturing site (OBL/OEM site change). In the 2026 procurement cycle, will our E-Katalog listing be 'frozen' or hidden the moment we hit the 'Submit' button for the amendment in Regalkes? We are worried about missing a 5-billion IDR tender during the 3-month evaluation period.

ElendiLabs

In 2026, the synchronization between Regalkes and LKPP (E-Katalog) is automatic. Crucially, as long as your current NIE has not expired, the existing listing remains active during the amendment review.The Switch-over: The E-Katalog entry will trigger an update notification once the new (amended) NIE certificate is issued. At that point, your local representative could update the certificate in the LKPP portal to avoid a mismatch. Therefore, your tender participation will likely not be interrupted by the ongoing amendment process.

A
Guest

我们目前的 NIE 由一家本地经销商持有。由于其业绩未达标，我们计划在 2026 年将执照转给另一家公司作为独立代理人。如果该经销商拒绝签署释放函 (Letter of Release)，我们能否利用 Permenkes 11/2025 中的‘行政干预’条款？系统中的‘6 个月冷却期’是否会自动触发？

ElendiLabs

自动处理机制： 在 2026 年的 Regalkes 系统中，如果您能提供经过公证的《终止合作通知书》，您可以向卫生部 (MoH) 提出申诉。冷却期逻辑： 卫生部会给予原经销商一个申辩期。如果经销商无法提供法律依据，系统将进入 6 个月的行政锁定/冷却期。在此之后，卫生部有权直接注销原 NIE，允许您（通过新公司）重新申请。注意： 这种方式属于“新注册”，不能走简单的变更流程，因此建议尽早启动。

D
Guest

As the October 17, 2026 deadline for mandatory Halal labeling for Class A devices approaches, we need to amend over 50 individual NIEs to include the BPJPH Halal Logo on our packaging. Does the MoH offer a 'Bulk Amendment' pathway for administrative labeling changes to avoid 50 separate submissions? And can we use the 'Sticker' method for products currently sitting in our Jakarta bonded warehouse without re-applying for a full technical variation?

ElendiLabs

Bulk Processing: The MoH has introduced an 'Product Grouping' feature for labeling updates. You can link multiple related products in one administrative session based on their similarity in intended use and product category. Sticker Compliance: Yes, for existing stock (pre-import or in bonded zones), the MoH allows over-labeling (stickers). However, you must submit a Change Notification specifically for the "Labeling Layout." Once the "Label Change" is approved in the system, the stickered products are considered fully compliant for distribution.

R
Guest

我们的影像类医疗器械软件 (SaMD) 计划进行版本升级。如果升级仅涉及 UI 界面优化和已获批算法的补丁修复，我们可以走变更流程吗？如果新版本增加了‘AI 辅助评估’功能，但硬件参数未变，卫生部会要求我们申请全新的 NIE 还是允许通过‘重大变更 (Major Amendment)’完成？

ElendiLabs

判定标准： 2026 年的监管准则是“预期用途是否发生实质改变”。变更 vs. 新注册： 仅 UI 优化和 Bug 修复属于 Minor Amendment，流程极快。但若增加了“AI 辅助评估”，这被视为增加了临床预期用途。根据 2025 年新规，这通常不被视为变更，而是有机会被要求进行 “New Registration (新注册)”。这意味着您将获得一个全新的 NIE 编号，且必须提交完整的临床评价报告 (CER)。

A
Guest

我们有一款已获得 NIE 的 II 类耗材，计划将外包装箱尺寸缩小以优化物流成本，并基于新的实时稳定性数据将有效期从 24 个月延长至 36 个月。在 Permenkes 11/2025 框架下，这两项变更是否可以合并为一个‘变更通知 (Change Notification)’提交？申请期间，旧包装和旧有效期的产品是否可以继续清关？

ElendiLabs

合并申请： 在印度尼西亚，医疗器械包装尺寸的变更通常被视为对现有许可证（NIE）的修订，但稳定性或保质期的重大变更通常需要重新提交注册申请。如果保质期变更被认为较为重大，则不太可能将这两项变更合并。清关连续性： 在变更审批期间（通常为 10-15 个工作日，若涉及技术审查有机会需 3 个月或更长），您仍可使用原有的 NIE 证书清关旧版产品。一旦新证书签发，您必须确保进入印尼市场的货物标签与新获批的规格完全一致。

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