Most foreign manufacturers who approach Indonesia for the first time come with a plan that has already worked somewhere else. That is usually the first problem.
In a recent episode of The Elendi Files, Teddy, General Manager of ElendiLabs, sat down with Hussein H. Mashhour 博士，医学博士, Co-founder and COO of 印度尼西亚产品注册, to talk through what it really takes to get a medical product registered and distributed in Indonesia.
ElendiLabs is a global platform that connects manufacturers with verified regulatory consultants across markets worldwide, and the conversation was exactly the kind of frank, practical exchange that does not usually make it into official guidance documents.
Listen to the full episode on The Elendi Files.
About Dr. Hussein H. Mashhour
Dr. Hussein H. Mashhour is a licensed medical doctor and healthcare executive with over a decade of experience in pharmaceuticals, medical devices, and digital health. He has worked with multinational corporations and has mentored early-stage health companies through the Austrade Landing Pad program. His expertise covers market access, stakeholder mapping, and healthcare compliance, with a focus on helping international companies enter and grow in Southeast Asian markets.
As Co-founder and COO of Product Registration Indonesia, Hussein leads a team with more than three decades of combined regulatory experience across medical devices, supplements, quasi-medicine, herbal standardized medicine, and halal products.
The Biggest Misconception Foreign Manufacturers Have About Indonesia
When Teddy asked Hussein what international manufacturers most commonly get wrong, his answer was direct.
Many international manufacturers think that the business model that works everywhere else will work in Indonesia. That’s the biggest misconception.
Indonesia is an archipelago of over 17,000 islands with thousands of local languages and a distribution infrastructure that varies considerably from one region to the next. A market entry approach built for a more centralised, single-channel market is unlikely to translate well here.
Hussein also points out something that many manufacturers overlook: product registration is not the end goal. Securing a marketing authorisation is just the first step. Turning that authorisation into actual sales requires a solid understanding of how distribution, reimbursement channels, and government procurement work in Indonesia specifically.
Companies that treat registration as the finish line often find themselves with a registered product and very little commercial traction to show for it.
Local Authorised Representative in Indonesia: What You Need to Know?
The local authorised representative requirement is one of the most important aspects of entering the Indonesian medical device market, and one that many foreign manufacturers do not fully understand until they are already in the middle of the process.
The Basic Rule
Foreign manufacturers must appoint a local entity to serve as the registered license holder for their products. This entity holds the marketing authorisation. Indonesia follows an exclusive distributorship model for product registration, which means one SKU can only be registered under one distributor. There is no flexibility on this point.
The Risk of Distributor Lock-in
That exclusivity comes with a real downside that is easy to miss during the initial planning stage.
We’ve seen many bad stories where a manufacturer gets locked in with a distributor that doesn’t perform, Hussein says.
Because the product license sits with the distributor, a manufacturer dealing with an underperforming partner has very little room to move. Replacing the distributor or changing the commercial strategy can become a slow and expensive process, and in some cases, products end up stuck with no clear path forward.
How the Independent License Holder Model Works
This is the problem that our independent license holder model was built to solve.
Instead of registering products under a commercial distributor, we serve as the local authorised representative and license holder without taking on any commercial role itself.
The manufacturer keeps full control over how their products are sold and distributed. They can appoint multiple sub-distributors for different regions, for example, one for Java and one for Sumatra, or split by channel, such as private hospitals versus the national reimbursement scheme. If a sub-distributor is not performing, they can be replaced without putting the product license at risk.
It is a practical way to keep the regulatory side of market entry separate from the commercial side, and it gives manufacturers a level of flexibility that the traditional distributor model does not offer.
Want to learn more about the independent license holder model? Explore our License Holder Service
What the Official SLA Says and What Actually Happens?
For a Class A medical device, the Ministry of Health (MoH) service level agreement is structured as follows:
| Process Step | Official SLA (Working Days) | Realistic Timeline |
|---|---|---|
| Initial MoH Submission | 15个工作日 | |
| Supplemental Review (if requested) | 10 + 10 working days | |
| Total Class A Process | ~45 working days | 2.5 to 3 months |
The fastest turnaround PRI has achieved for a Class A registration is around two and a half to three months. The gap between working days and actual calendar months generally comes down to two recurring issues.
Document readiness. The most common source of delay is the manufacturer’s own document preparation, particularly the Letter of Authorization (LOA). Indonesia accepts apostilled documents, but Hussein recommends routing documentation through the Indonesian embassy for manufacturers in countries where language differences could create problems at the review stage.
System limitations on the government side. Indonesia has fully moved to digital submissions and no longer accepts paper applications. The government’s online system, however, has not always kept up with the volume of submissions coming through. We manage this by working directly with designated contacts at the Ministry of Health, which helps keep applications moving when the system creates delays.
Compliance Requirements That Directly Affect Your Ability to Register and Sell
Beyond the core registration process, there are several compliance requirements that have a direct impact on whether a foreign manufacturer can register new products, participate in government procurement, or avoid problems at customs.
CDAKB: Good Distribution Practice Certification
CDAKB has been mandatory for medical device distribution in Indonesia since July 2024. Without a valid CDAKB certification, a company cannot register new products and cannot take part in government tenders. Products that are already registered are not affected, but any new registration or tender submission requires the certification to be uploaded as part of the process.
TKDN: Local Content and Government Procurement
TKDN refers to Indonesia’s local content requirements, which apply to government procurement. Hussein describes the policy as “obligatory favoritism”: when a product has more than 40% Indonesian local content, government hospitals are required to choose it over competing products with lower local content when both are available.
For manufacturers with novel products that have no domestic equivalent, a 0% TKDN figure is acceptable. In remote regions like Papua, lower local content thresholds are also permitted, though Hussein notes that hospitals in those areas tend to face more government audits. Some procurement teams choose to avoid purchasing products below the 40% threshold simply to reduce the risk of that scrutiny.
清真认证
Halal is not yet a hard regulatory requirement for medical devices in Indonesia, but it is already having a practical impact. The halal classification is now tied to HS codes, which means certain products can encounter issues at customs before they even reach the registration stage.
Given that between 80 and 90 percent of Indonesia’s population is Muslim, the direction of regulation is clear. The government is moving toward requiring non-halal product labelling that visibly identifies products that do not meet halal requirements.
Manufacturers who hold halal assessments from recognised bodies in countries like the United States or United Kingdom can use mutual recognition agreements to speed up the local process, but this does not automatically give their products halal status in Indonesia.
CE Mark and US FDA Approval
CE marking and US FDA clearance are useful but not sufficient on their own. The Certificate of Free Sale from the country of manufacture is still the primary mandatory document. Having a CE mark or FDA approval can reduce the amount of supporting data the Ministry of Health asks for during the review process, which speeds things up, but it does not replace any of the mandatory requirements.
IDAK: The New Distributor License
IDAK replaced the older IPAK distributor license and is now the standard license for medical device distribution rights in Indonesia. The key difference is that IDAK has a five-year validity period, whereas IPAK was indefinite. The migration process is straightforward and typically takes around 15 working days.
Product Registration Indonesia and ElendiLabs: Connecting Global Reach with Local Expertise
The interview between Hussein and Teddy was also the starting point of a formal working relationship between PRI and ElendiLabs.
ElendiLabs runs a global regulatory consultancy network where manufacturers can post questions, request quotations, and connect directly with vetted regulatory specialists across markets in Asia Pacific, Europe, and beyond.
Following the interview, Product Registration Indonesia has been listed as a verified specialist firm on the ElendiLabs platform for the Indonesian market. For manufacturers already using ElendiLabs to find regulatory support in other markets, this means they now have a direct line to PRI’s expertise when Indonesia comes into their plans.
Before You Sign Any Distribution Agreement
Indonesia’s medical device market has real commercial potential, but it also has a regulatory and commercial structure that is genuinely different from most other markets in the region. Getting the structure right before committing to a distributor matters more here than in most places.
Distributor lock-in, a missing CDAKB certification, or a misread of the TKDN requirements can cause serious delays and add high cost to a market entry that should have been straightforward.
侯赛因·H·马什豪尔博士 and the team at Product Registration Indonesia work specifically on these challenges for international manufacturers. If you are assessing Indonesia as a target market, it is worth understanding the independent license holder model before any agreements are in place.
