AUTHORIZED REPRESENTATIVE (MEDICAL DEVICES - INDONESIA)

Regulatory Requirements 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.

Requirements for Medical Device Registration in Indonesia

Companies wnting to place medical devices on the market in Indonesia must prove they own several licenses before registering medical devices in Indonesia with the Ministry of Health. The crucial documents are:

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 / authorised Representitive.

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, the maximum of foreign shares is 49%.

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 is responsible for registering medical devices and household health supplies in Indonesia. The Common Submission Dossier Template (CSDT) format is the standard for medical device registration applications in Indonesia. The document aims to provide a standard template for submitting medical device information to the regulatory authorities of ASEAN member countries.

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.

2022 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:

• Company Documents: Single Business Identity Number (NIB), Company’s Tax ID (NPWP), Medical Device Distributor License (IDAK), etc.
• 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).
• Technical Documents: Dossier from Manufacturer

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

  Sophisticated medical devices like X-rays, ECGs, in-patient monitoring systems, orthopedic implants, contact lenses, oximeters, and others can potentially harm a patient’s health if not used by qualified individuals.

  While they may not be life-threatening, they require safe operation expertise. Assessing these products involves a detailed evaluation, including risk analysis, and manufacturers must provide safety information. However, clinical tests are not mandatory for these devices.

• Class D – High risk

  Improper handling of certain medical products and devices can lead to severe or fatal consequences for patients and medical professionals. High-risk items such as CT scans, MRIs, cardiac catheters, cardiac stents, HIV tests, pacemakers, dermal fillers, and many others require a thorough evaluation before distributing them.

  Manufacturers must conduct clinical tests, publish articles in reputable journals, and perform risk analysis to gain approval. They must also provide safety information. It’s important to note that this evaluation process comes with a fee that depends on the device’s classification. This fee must be paid before proceeding with the necessary paperwork.

Distribution of Medical Devices License (Nomor Izin Edar)

Even the registered products in their origin country can only be considered for the Indonesian market if you are granted the Distribution License for Medical Devices (NIE) issued by the MoH.

An NIE requires manufacturers to comply with approved labeling/packaging requirements and meet specific product qualities. An e-report regarding your product should be submitted every six months.

Besides the basic information such as product name, batch number/production number, and expiry date, additional data about the manufacturer and distributor should be provided. The Ministry of Health also requires the IFU translation from the original language into Indonesian.

As the conditions vary a lot for different products, it might be challenging to follow compliance and stay caught up regarding red tape. Consider an experienced company such as InCorp Indonesia to be in charge of making sure the legal proceedings go as smoothly as possible.

Post-market Entering Control

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.