How to Get Chinese Medical Devices Approved in Indonesia Successfully

Indonesia offers strong market opportunities for Chinese medical device companies, but entering the market requires more than appointing a distributor. 

Every imported device needs an Izin Edar (NIE) from the Ministry of Health, and an eligible Indonesian company must hold that approval. Businesses must therefore secure the necessary licences, obtain product approval, and establish a compliant local structure. 

Choosing the right licence holder matters, as it directly affects registration, distributor flexibility, and long-term market access. 

Key Takeaways

• Chinese companies need an eligible Indonesian legal entity to hold the product registration and manage local regulatory obligations. 
• Under Permenkes 5/2026, Medical device approval requires a company-level distribution licence (IDAK), CDAKB compliance, and a product-level Izin Edar (NIE). 
• Device classification, technical documentation, CSDT requirements, and halal obligations should be assessed before submitting an application. 
• Selecting a distributor as the licence holder may create difficulties when changing commercial partners or expanding distribution networks. 
• Under Government Regulation No. 40/2026, the halal deadline for Class A medical devices is now October 17, 2028. 
• Ascentium Indonesia (formerly InCorp Indonesia) supports Chinese medical device companies with product registration, local licence-holder arrangements, and ongoing regulatory compliance.

Medical Device Registration in Indonesia at a Glance 

Compliance Area	What Chinese Companies Need to Know
Regulatory authority	Ministry of Health (Kemenkes)
Local legal entity	Eligible Indonesian company to hold the product registration
Distribution licence	Izin Distribusi Alat Kesehatan (IDAK)
Product approval	Izin Edar (NIE), generally AKL for imported medical devices
Device classification	Classes A, B, C, and D, based on risk level
Technical documentation	CSDT and applicable supporting documents
Distribution standard	Cara Distribusi Alat Kesehatan yang Baik (CDAKB)
Halal requirements	Based on device classification and applicable deadlines
Registration validity	Generally, up to five years, subject to approval conditions
Post-approval obligations	Product monitoring, regulatory reporting, updates, and NIE renewal

Why Indonesia is an Attractive Market for Chinese Medical Device Companies 

Indonesia’s healthcare investment and reliance on imported medical devices create significant opportunities for Chinese companies. 

Key market indicators include: 

• 2026 Healthcare Spending: Indonesia allocated IDR 244 trillion to healthcare, including hospital revitalisation and improved medical facilities. 
• Healthcare Budget Growth: The 2026 allocation represents a 15.8% increase compared with the 2025 budget outlook of IDR 210.6 trillion. 
• Medical Device Imports: Indonesia imported USD 738.66 million in medical devices in 2025, with China as its largest supplier, contributing USD 198.05 million. 
• Chinese Products in Indonesia: Ministry of Health data cited in September 2026 identified 24,021 active imported medical device products originating from China. 

These market conditions create opportunities for companies in diagnostic equipment, patient monitoring devices, hospital equipment, medical consumables, and other healthcare technologies. 

However, strong market demand doesn’t automatically mean a product is ready for distribution. Before distribution, you must secure the appropriate product approvals, local licences, and licence-holder arrangements. 

Where Chinese Medical Device Companies Run into Problems 

Chinese medical device companies often face registration delays and distribution challenges because of gaps in local licensing, documentation, and market-entry planning. 

Dependence on a Local Distributor 

When distributors also hold product registrations, companies may face: 

• Limited flexibility to appoint new distributors. 
• Complications when changing distribution partners. 
• Potential disruption to product registration and market access. 

Incomplete Registration Documents 

International certifications such as CE marking or NMPA approval do not automatically qualify medical devices for approval in Indonesia. Common gaps include: 

• Incomplete CSDT (ASEAN Common Submission Dossier Template) and technical documentation. 
• Inconsistent product specifications and certificates. 
• Missing manufacturer authorisations or required labelling. 

Distributor Licensing Gaps 

An established distributor may not have the required licences to handle specific medical devices. Common issues include: 

• Missing or unsuitable IDAK (Izin Distribusi Alat Kesehatan), the medical device distribution licence. 
• Failure to meet CDAKB (Good Distribution Practice for medical devices) requirements. 
• Licences that do not cover the intended product categories. 

Registration That Does Not Support Expansion 

Existing registration arrangements may create challenges when companies expand their product portfolios or distribution networks, including: 

• Additional registrations for new products. 
• Restrictions under existing manufacturer authorisations. 
• Delays when changing licence holders or distributors. 

To avoid these challenges, you should assess local licence-holder arrangements, verify distributor eligibility, and align registration requirements with long-term market-entry plans before submitting applications. 

READ MORE:

• Indonesia Business Setup Guide for Chinese Manufacturers
• How Consulting Firms Help Chinese Investors Enter Indonesia
• Why Relocating to Indonesia is a Smart Strategy for Chinese Companies

What Chinese Medical Device Companies Need to Get Right Before Applying 

Before applying for medical device registration in Indonesia, you must verify the following requirements to avoid delays and compliance issues. Since May 4, 2026, these requirements sit under Permenkes 5/2026 on Health Supplies, which consolidated 40 earlier health regulations and repealed Permenkes 62/2017. 

Medical Device Classification 

Indonesia classifies medical devices into four risk categories that determine registration requirements. 

Class	Risk Level	Example Devices	What It Means for Registration
A	Low	Non-sterile examination gloves, bandages, wheelchairs	Lightest dossier and fastest review
B	Low to moderate	Blood pressure monitors, hypodermic needles, steam sterilisers	Fuller technical documentation
C	Moderate to high	Ventilators, infusion pumps, bone fixation implants	Detailed safety and performance evidence
D	High	Heart valves, implantable pacemakers	Most extensive evidence, including clinical data

Chinese medical device companies need an eligible Indonesian entity to hold the product registration. Key requirements include: 

• IDAK: Relevant medical device distribution authorisation. 
• CDAKB: Compliance with Good Distribution Practice requirements. 
• Local Licence Holder: An authorised Indonesian entity (Pemegang Izin Edar) responsible for product registration. 

Product Registration Documents 

Required documentation varies by product classification but commonly includes: 

• Letter of Authorisation (LoA) from the legal manufacturer. 
• Certificate of Free Sale (CFS), where applicable. 
• ISO 13485 and relevant quality management documentation. 
• CSDT, technical specifications, and test reports. 
• Product labels and instructions for use, including applicable Bahasa Indonesia requirements. 

Medical Device Approval (NIE) 

Medical devices generally require an Izin Edar (NIE) before commercial distribution in Indonesia. 

• AKL: Imported medical devices, including products from China. 
• AKD: Locally manufactured medical devices. 
• Validity: Generally, up to five years, subject to approved authorisation. 

Submit applications through the Ministry of Health’s Regalkes system. 

Halal and Post-Market Compliance 

You must assess applicable halal obligations and maintain compliance after product approval. 

Government Regulation No. 40/2026, enacted on October 14, 2026, amends PP 42/2024 and extends the mandatory halal certification transition for Class A medical devices to October 17, 2028, replacing the earlier 2026 deadline. The deadlines for Classes B, C, and D remain unchanged. 

The current phased deadlines are: 

• Class A: October 17, 2028 
• Class B: October 17, 2029 
• Class C: October 17, 2034 
• Class D: October 17, 2039 

Halal requirements depend on the device’s materials, manufacturing processes, and classification. Devices containing animal-derived materials need particular attention.  

You must also maintain post-market compliance, including product traceability, safety reporting, and regulatory updates. Software-based devices now follow Kepmenkes 951/2026, the Ministry of Health’s dedicated guideline for registering software medical devices. 

What Happens After Medical Device Approval in Indonesia? 

Obtaining an NIE does not end a company’s regulatory obligations. To maintain market access, you must: 

• Maintain Valid Registrations: Renew the NIE before expiry. 
• Report Regulatory Changes: Update relevant product, manufacturer, or distributor information. 
• Maintain CDAKB Compliance: Meet applicable storage, handling, and distribution standards. 
• Monitor Product Safety: Manage complaints, adverse events, and recalls. 
• Fulfil Reporting Requirements: Maintain product records and submit required regulatory reports. 
• Monitor Halal Compliance: Meet applicable certification and labelling deadlines. 

Maintaining post-approval compliance helps you avoid regulatory sanctions, registration issues, and distribution disruptions. 

Risks If Chinese Medical Devices Are Not Properly Registered 

Without the required medical device approval (NIE), Chinese medical devices cannot be legally imported, distributed, or sold in Indonesia for commercial distribution. 

Non-compliance can also lead to: 

• Import Delays: Products may be held at customs or denied clearance. 
• Regulatory Sanctions: Fines, product recalls, or revocation of relevant licences, where applicable. 
• Distribution Disruptions: Invalid or expired registrations can interrupt product supply. 
• Licence-Holder Lock-In: Registrations held by a distributor can prevent you from switching partners without re-registering. 
• Additional Costs: Corrective actions, documentation revisions, and repeated applications. 
• Lost Business Opportunities: Delayed market entry, missed sales, and disrupted hospital supply agreements. 

Proper medical device registration helps companies avoid regulatory penalties, protect market access, and maintain uninterrupted distribution in Indonesia.

How Ascentium Supports Chinese Medical Device Companies in Indonesia 

Registering medical devices in Indonesia requires the right licences, documentation, and local representation. 

Ascentium Indonesia (formerly InCorp Indonesia) can help you secure product approval and maintain regulatory compliance. Our services include: 

• Medical Device Registration: Product classification, documentation preparation, and support for NIE applications. 
• Local Licence-Holder Services: Local representation and registration arrangements to support distribution flexibility. 
• IDAK and CDAKB Compliance: Support for medical device distribution licensing and regulatory requirements. 
• Post-Approval Support: NIE renewals, regulatory updates, and ongoing compliance. 

Our experience also includes supporting an international company in registering 37 products through an independent licence-holder arrangement, enabling greater distribution flexibility. 

READ MORE:

• Indonesia Product License Holder: Case Study on F&B Brand

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