For foreign medical device manufacturers, expanding into Indonesia often begins with one key question: “How much will medical device registration cost in Indonesia?” While regulatory hurdles such as documentation and classification are expected, the financial side of registration often creates confusion.
Some companies underestimate the budget, assuming it will be similar to CE Marking in Europe or FDA clearance in the US. Others rely on local distributors who promise “free” registration but later tie the brand’s market access to restrictive contracts. Both paths can lead to costly mistakes.
This article explains the real structure of Indonesia’s medical device registration fee, why it varies, what hidden costs to expect, and how to plan your budget strategically.
Types of Costs in Medical Device Registration
Unlike some markets where fees are straightforward, Indonesia’s medical device registration involves multiple categories of expenses:
- Non-tax government evaluation fees (PNBP)
- Paid directly to the Ministry of Health during dossier evaluation.
- Amount depends on risk class (A–D) and type of device.
- These fees are non-refundable, even if registration is delayed or rejected.
As of 2025, Class A devices incur around IDR 1.5 million in government fees, while Class D high-risk devices can cost up to IDR 5 million in PNBP fees. MoH also provides tariff simulation.
- Consultant Fees
- Costs for professional support in preparing dossiers, submitting through Regalkes, and handling clarifications.
- While optional, using consultants reduces the risk of rejections that could double your expenses.
Consultant fees can vary based on the scope of support, but investing in experienced local consultants often prevents costly resubmissions
- Document Legalization & Translation
- Certificates such as Certificate of Free Sale (CFS) and GMP must be legalized or apostilled. Indonesia joined the Hague Apostille Convention in 2022, meaning an apostilled document is now accepted in lieu of consular legalization in many cases
- Technical dossier documents can be submitted in English, but all user-facing content like IFUs, labels, and packaging must be in Indonesian.
- License Holding Fees
- If you don’t have a local entity, you must appoint either a distributor or a neutral license holder.
- A neutral license holder charges an annual license holding cost (custodianship fee) per product.
- Renewal & Post-Market Costs
- Registration (NIE) is valid for 5 years. Renewal involves both government and consultant fees. Renewal government fees are reduced – roughly IDR 500k for Class A and IDR 1,000k for Classes B–D as of 2025 – but you should still budget for consultant assistance during renewal.)
- Post-market obligations such as adverse event reporting or audits may also incur costs. Also, note that as of late 2023, the MoH encourages independent post-market testing of devices every two years. While currently voluntary, complying could become important for market access (e.g. e-catalog listing priority) – which means additional periodic costs for laboratory tests that weren’t part of your initial registration expenses.
Why Costs Vary by Risk Class and Product Portfolio
The cost of registration is not uniform—it depends on both risk classification and the size of your portfolio.
- Risk Class (A–D):
- Low-risk Class A products are cheaper and faster to register.
- High-risk Class D devices require more technical documentation, clinical evaluation, and higher evaluation fees.
- Product Portfolio Size:
- Registering a single product is relatively straightforward.
- Companies with multiple SKUs can benefit from bundling strategies—grouping similar devices to save on fees.
Indonesia’s MOH allows grouping of similar devices into one registration when they share the same intended use or product family. Planning your registrations to leverage these grouping rules can significantly cut down the total number of submissions – manufacturers who bundle eligible devices under one application often save tens of thousands in fees.
???? Business insight: Manufacturers that plan product bundling from the start often save tens of thousands of dollars in registration costs.
Hidden Costs Foreign Manufacturers Often Miss
Many companies, especially first-time entrants, fail to account for indirect or “hidden” costs.
- Translation Costs
Every document and label must be in Bahasa Indonesia. For companies with extensive manuals or packaging, this becomes a significant expense. Note that translations must be done by certified/sworn translators, and costs are typically calculated per word or page. A large 100-page technical manual or extensive packaging artwork can incur thousands of dollars in translation expenses – a commonly underestimated cost. Plan for this by budgeting for professional Bahasa Indonesia translation of all user-facing materials. - Local Testing (if required)
The Ministry of Health may request local testing for certain devices, especially in high-risk categories. These tests must be conducted in accredited Indonesian labs. For example, if you have a Class D device without prior recognized approvals (or certain IVD diagnostic kits), the MoH might request performance testing in an accredited Indonesian lab. Such local testing can cost several thousand dollars and add a few months to your timeline. Manufacturers should account for potential lab fees and delays if their product falls into a category likely to trigger local testing. - Opportunity Cost of Delays
Delays in document legalization, Regalkes clarifications, or distributor issues translate into lost market opportunities. In fast-moving segments like diagnostics or hospital consumables, every month of delay can cost millions in sales. - Distributor Dependence
Some distributors offer to cover registration costs. However, this often locks the manufacturer into long-term exclusive agreements. The “hidden cost” is losing control of your product licenses. In practice, if you ever want to change distributors, you’ll need to re-register your product under a new license holder from scratch. That means paying all government fees again and enduring another approval process. This costly do-over is the hidden price of ‘free registration’ by a distributor.
Cost vs Control: The License Holding Dilemma
Foreign manufacturers typically face two options when registering in Indonesia:
- Distributor as License Holder
- Usually marketed as “free” registration.
- But the distributor owns the license, meaning you cannot switch partners without re-registering products.
- Risk: Losing market control if the distributor underperforms.
- Neutral License Holder (e.g., PRI)
- Involves annual license-holding fees.
- But the manufacturer retains ownership and can appoint or change distributors freely.
- This approach secures long-term control and flexibility, which is often more valuable than short-term savings.
???? Business insight: For high-value or high-volume devices, paying license-holding fees is a strategic investment to maintain independence in the market.
Best Practices for Budgeting Your Registration
To avoid surprises, foreign manufacturers should approach cost planning as part of their market entry strategy, not as an afterthought.
- Plan for Both Registration & Renewal
- Budget not only for initial registration but also for renewal every 5 years.
- Consider post-market surveillance and compliance costs upfront.
- Allocate a Buffer for Compliance Gaps
- If MoH requests additional documents or audits, unexpected expenses can arise.
- A buffer of 10–20% above initial estimates is recommended.
- Negotiate Distributor Arrangements Carefully
- Do not let “free registration” offers lock you into unfavorable contracts.
- Clarify upfront who pays for renewals and surveillance reporting.
- Work with Consultants for Realistic Estimates
- Consultants with local experience can forecast costs more accurately.
- They also prevent errors that can lead to resubmissions and doubled expenses.
How PRI Helps Optimize Medical Device Registration Cost?
At Product Registration Indonesia (PRI), we help manufacturers manage both the regulatory and financial aspects of entering Indonesia.
- Transparent Cost Breakdown: No hidden fees—clear estimates for government, consultant, and custodianship costs.
- Bundling Strategies: Group products efficiently to reduce registration expenses.
- Neutral License Holding: Maintain control of product licenses while still complying with MoH requirements.
- Risk Reduction: Minimize rejections and clarifications that lead to additional fees.
With PRI, manufacturers can approach Indonesia’s regulatory environment with confidence, knowing that their budget is planned, optimized, and under control.
Conclusion
The cost of medical device registration in Indonesia is more than just a line item – it’s a critical part of market entry planning. From government fees and consultant fees to hidden costs like translation and distributor dependence, every expense has strategic implications.
Manufacturers that plan ahead, invest in license holding, and work with experienced consultants will not only reduce costs but also gain control, speed, and flexibility in the Indonesian market.
Contact Product Registration Indonesia today for a clear cost breakdown and tailored budgeting strategy. With our support, you can enter Indonesia with confidence—on time and on budget.
