A Simple Guide to Medical Device Registration in Indonesia

Indonesia’s healthcare sector has great potential for growth. The government is encouraging local medical device production, but there are limitations due to a lack of raw materials and technological advancements.

Foreign manufacturers should exploit this moment to explore new, profitable markets. However, trading in the medical industry requires awareness of regulations. Importing is essential for high-value-added products and intricate devices, as domestic production focuses on disposable items.

Regulatory Bodies Regarding Indonesia Medical Device Registration

The Ministry of Health of the Republic of Indonesia defines medical devices and products as instruments, apparatuses, machines, and/or implants. These items are used to prevent, diagnose, cure, and relieve diseases, treat sick people, recover the health of human beings, and/or form the structure and correct the body function, and they do not contain drugs.

This broad definition can be found in Article 1 of MoH Regulation No. 62 Year 2017, which deals with the Distribution License of Medical Devices, In Vitro Diagnostic, and Household Health Supplies. This regulation is issued by the Director General of Pharmacy and Medical Devices at the Indonesian Ministry of Health.

Document Requirements for Registering Medical Devices in Indonesia

To complete the registration of a medical device in Indonesia, adhere to the ASEAN Common Submission Dossier Template (CSDT) by providing the following documentation:

1. Executive Summary
2. Relevant Essential Principles and Methods Used to Demonstrate
   • Essential Principles and Evidence of Conformity
3. Device Description
   • Device Description and Features
   • Intended Use
   • Indications
   • Instructions of Use
   • Contraindications
   • Warnings
   • Precautions
   • Potential Adverse Effects
   • Alternative Therapy
   • Materials
   • Other Relevant Specifications
   • Other Descriptive Information
4. Summary of Design Verification and Validation Documents
   • Pre-clinical Studies
   • Software Verification and Validation Studies (if applicable)
   • Devices Containing Biological Material
   • Clinical Evidence
   • Use of Existing Bibliography
5. Device Labelling
   • Samples of Labels on the Device and its Packaging
   • Instructions for Use
6. Risk Analysis
   • Results of Risk Analysis
7. Manufacturer Information
   • Manufacturing Process

Ensuring the submission of these documents is crucial for a successful medical device registration process in Indonesia.

Requirements for Medical Device Registration in Indonesia

Before registering medical devices in Indonesia, entrepreneurs aspiring to trade them must prove that they own several licenses from the Ministry of Health. The crucial documents include:

Permanent Business License (Izin Usaha)

Foreign companies can only distribute medical products in Indonesia if they establish a limited company with direct foreign investment (PT PMA) or find a local distributor. Your company also needs a permanent Business License from the Ministry of Investment (BKPM) as one of the prerequisites to starting a PT PMA.

Furthermore, entrepreneurs should know about the Positive Investment List to enter the healthcare sector. The list has regulations on the company’s maximum percentage of foreign shares.  In the healthcare sector (Pharmaceutical industry and Hospital), regulatory amendments have allowed foreigners to possess full ownership—up to 100%—of shares.

Registration License (ASEAN Common Submission Dossier Template) 

Indonesia participates in the ASEAN Conformity Committee for Standard and Quality Medical Devices Product Working Group (ACCSQ-MDPWG). With that, Indonesia actively contributes to harmonizing medical device regulations within ASEAN. This collaboration involves the development of guidelines for medical devices based on the ASEAN Medical Device Directive.

The ASEAN Medical Device Directive regulates medical device and household health supply registration in Indonesia. The Common Submission Dossier Template (CSDT) is the standard format for registration, providing a uniform template for submitting medical device information to ASEAN regulatory authorities.

Manufacturer License

The license confirms that a product meets Indonesian and international quality, effectiveness, and safety standards, which is an. ISO 13485:2016. It is a quality management systems certification. An organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Medical Devices Distributor License (Izin Penyalur Alat Kesehatan)

A medical device distributor in the form of a legal entity should be licensed to perform a series of distribution or delivery activities with a Medical Devices Distributor License (IDAK). There also should be a dedicated person who acts as a Technical Responsible Person with sufficient educational background according to the medical device category, such as:

• Electromedical with radiation
• Electromedical without radiation
• Non-electromedical sterile
• Non-electromedical non-sterile
• In-vitro Diagnostic Products

Nevertheless, further steps must be taken before signing your first business deal.

2024 Update on Medical Device Registration and Import in Indonesia

To register a medical device in Indonesia, you are required to submit an online application with the following documents:

1. Company Documents:
   • Single Business Identity Number (NIB)
   • Company’s Tax ID (NPWP)
   • Medical Device Distributor License (IDAK), etc.
2. Administrative Documents:
   • Letter of Authorization (LoA)
   • Free Sales Certificate
   • Production License of Medical Device issued by Indonesian MoH (local product) / ISO 13485 Certificate (import product).
3. Technical Documents:
   • Dossier from Manufacturer
4. Certificate of Standard for Medical Device Distribution (Cara Distribusi Alat Kesehatan yang Baik)
5. Good Manufacturing Practice of Medical Device Certification (CPAKB)

As of 1 January 2024, CPAKB (Cara Pembuatan Alat Kesehatan yang Baik) certificate is mandatory for companies that produce and distribute medical devices. CPAKB is a guideline used in various activities to manufacture Medical Devices and quality control. It aims to ensure that the produced medical device products meet the requirements of their intended use

To register a medical device, the procedure is as follows:

• Log in to the Medical Device Registration Account via the OSS RBA system.
• Upload the registration documents
• Pay the government fee and wait for the evaluation result.
• Products can be sold and distributed after getting a medical device license (valid for five years or according to the validity of LoA)

The government has implemented the Online Single Submission (OSS) system since July 2018 to shorten the process of securing an import license. All business entities are required to register through the OSS. Once completed, a Business Identification Number (NIB) is issued automatically.

The NIB is the basic Import License and replaces the Company Registration Certificate (TDP) and Importer Identification Number (API).

Risk Evaluation

The long and highly bureaucratic market-entering process has been facilitated by harmonizing Indonesian regulations with the rest of the ASEAN countries under the Medical Device Directive (AMDD).

In addition, the AMDD has changed the classification of medical products based on the risk they can cause if mishandled. A four-grade evaluation system has replaced the former three categories.

Class A – Low risk

There’s a wide range of medical items, like medical cotton, bandages, gauze, sanitary pads, walking canes, and even more substantial equipment such as wheelchairs and adjustable beds. These products generally don’t pose significant risks if misused. When assessing them, the main concerns are quality and how long they last.

Class B – Low to moderate risk

Products and devices that could impact the patient’s health in case of malfunction or if not used properly. This includes electric hospital beds, surgical masks, gloves, syringes, and hemodialysis fluids. Clinical tests are not involved in the evaluation of medical instruments. A set of requirements has to be met.

Class C – Moderate to high-risk

Medical devices like X-rays, ECGs, monitoring systems, implants, and oximeters can harm patients if not used by experts. While not life-threatening, they require safe operation expertise and risk analysis. Manufacturers must provide safety information, but clinical tests are not mandatory.

Class D – High risk

Certain medical products and devices can be risky and require thorough evaluation before distribution. Manufacturers must conduct clinical tests, publish articles, and perform risk analysis to gain approval. 

This evaluation process comes with a fee that depends on the device’s classification and must be paid before proceeding with the necessary paperwork.

The Benefits of Having Medical Device License in Indonesia

Benefits of having an Independent License Holder for a medical device in Indonesia:

1. Direct Sales to Regional Distributors: Sell to various regional distributors without added mark-ups from a national importer.
2. Enhanced Transfer Pricing: Optimize pricing for potential cost efficiencies.
3. Stronger Negotiation Leverage: Improve negotiation positions and responses when working with distributors.
4. Distributor Flexibility: Easily add or change distributors as needed for adaptable distribution strategies.
5. Intellectual Property Protection: Safeguard intellectual property by keeping it separate from local commercial agents.
6. Importance in e-Catalogue System: Particularly relevant in the e-Catalogue system, eliminating regional-dealer margins in the pricing structure.

For assistance in navigating medical device regulations in Indonesia, Asia Actual is ready to provide support.

Distribution of Medical Devices License (Nomor Izin Edar)

Obtaining a Distribution License for Medical Devices (NIE) issued by the MoH is mandatory to sell medical devices in Indonesia. You must ensure your products comply with approved labeling and packaging requirements and meet specific quality standards. 

Also, you must submit an e-report every six months containing basic information such as product name, batch number/production number, and expiry date. If you need any assistance with compliance and legal proceedings, feel free to contact InCorp Indonesia.

Post-market Entering Control for Indonesia Medical Device Registration

After the product is launched, it remains under the authorities’ control. Monitoring is conducted according to the AMDD guidelines, including sampling, vigilance, and advertising to ensure permanent quality.

Start Registering Your Products with InCorp Indonesia

To take advantage of the thriving opportunities in Indonesia’s healthcare sector and successfully register your medical products, contact InCorp Indonesia today. Our experienced team is ready to guide you through the complex process, ensuring compliance with all regulations. 

Don’t miss out on the chance to tap into this underdeveloped market. Fill out the form below, and let InCorp Indonesia be your partner in navigating the intricate landscape of Indonesia’s medical device registration.