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medical product registration indonesia

A Simple Guide to Indonesia Medical Device Registration

Indonesia’s thriving population, growing economy, and still largely underdeveloped health sector make the perfect combination for up-and-coming business with medical products in this country.

Since domestic production is mostly oriented on some of the disposable items, other consumable medical products, high value-added products, and sophisticated devices must be imported.

It brings bright prospects for foreign manufacturers who are looking for new profitable markets. There is, however, a wide range of precautions anyone considering to trade in this highly regulated area should be aware of.

Regulatory Bodies regarding Indonesia Medical Device Registration

Ministry of Health of the Republic of Indonesia defines medical devices and products as:

Instruments, apparatuses, machines, and/or implants that do not contain drugs 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.

This general definition stated in articles 1 and 3 of regulation No. 1190/MENKES/PER/VIII/2010 dealing with medical devices and household products is further specified in documents issued by the Directorate of Medical Device Production & Distribution Development and Directorate General of Pharmaceutical Services & Medical Devices.

The National Agency of Drug and Food Control is another governmental institution that is in charge of medical product control. Its role is to evaluate whether the product meets all the requirements to enter the market. Moreover, the goal of the supervision is to ensure quality and safety, increase availability, and also the affordability of medical products throughout the country.

Requirements for Medical Device Registration in Indonesia

The entrepreneur aspiring for trading with medical devices in Indonesia must prove that he or she is in possession of several licenses before going through the medical product registration in Indonesia with the Ministry of Health. The crucial documents are:

Permanent Business License (Izin Usaha)

Foreign companies are not allowed to do business with medical products in Indonesia unless they establish a limited company with direct foreign investment (PT PMA) or find a local distributor.

Permanent Business License issued by Investment Coordinating Board (BKPM) is one of the prerequisites to run PT PMA.

Furthermore, having the intention to do business in the sector of healthcare, the entrepreneur should be aware of the Negative Investment List that regulates the maximum percentage of foreign share in the company for various fields, including healthcare where the maximum of foreign shares is 49 percent.

Registration License (ASEAN Common Submission Dossier Template)

Indonesia has joined the common registration policy of the ASEAN countries which means that registrant of a medical device is obliged to submit a wide range of information to ASEAN regulatory authorities.

Common Submission Dossier Templates (CSDT) is a platform for registration with the Health Sciences Authority (HSA) that is in charge of the mentioned agenda.

Manufacturer License

The license confirming that a product meets both Indonesian and international standards in terms of quality, effectiveness, and safety.

This is an international certification regulated by ISO 13485 issued on 1 March 2016 by International Organization for Standardization that deals with Medical devices, Quality management systems, and Requirements for regulatory purposes.

Medical Devices Distributor License (Izin Penyalur Alat Kesehatan)

Special distribution permission (IPAK) issued according to the usage of the medical device in question. The previously discussed Manufacturer License must be acquired before applying for the IPAK. A device can fall into one of the following categories:

a. Electromedical with radiation
b. Electromedical without radiation
c. Non-electromedical sterile
d. Non-electromedical non-sterile
e. In-vitro Diagnostic Products

After obtaining all the above-mentioned licenses and upon submitting other necessary documents (declaration of conformity, manufacturer information, device description, device labeling, design verification, and validation, etc.) the Ministry of Health will approve the registration.

Nevertheless, a couple of further steps still needs to be done before you can sign your first business deal.

2021 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), Trade Business License (SIUP), Importer Identification Number (API), plus Medical Device Distribution License (IPAK) for medical devices
  • Administrative Documents: Letter of Authorization (LoA), Free Sales Certificate, GMP Certificate/ISO
  • Technical Documents: Dossier from Manufacturer

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

  • Legal entity (company) registration at Ministry of Health: carried out online
  • Manufacturer (local products) registration: MoH inspection to the local manufacturer
  • Product registration after device class determination: products can be distributed and sold after getting a medical device license (valid for five years or according to the validity of LoA)

Medical device import license in Indonesia

The government has made effective the Online Single Submission (OSS) system since July 2018 to shorten the process of securing an import license that previously took up to five months in total.

All business entities are required to register through the OSS. Once the registration process is completed, a Business Identification Number (NIB) is issued automatically.

The NIB serves as 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, to some extent, facilitated by the harmonization of Indonesian regulations with the rest of ASEAN countries under the Medical Device Directive (AMDD).

In addition, the AMDD has brought changes into the classification of medical products on the basis of the risk they can cause if handled improperly. The former three categories have been replaced by a four grade-evaluation system.

Class A – Low risk

Devices and products that do not present any serious harm if mishandled include medical cotton, bandage, gauze, sanitary pads, walking canes, but also more expensive equipment such as wheelchairs or special adjustable beds.

This is a very broad group, and evaluation of these products is focused primarily on their quality and/or durability.

Class B – Low to moderate risk

Products and devices that could have a certain impact on the patient’s health in case of malfunction or if not used properly. We are talking about electric hospital beds, surgical masks, and gloves, syringes, or hemodialysis fluids to name just a few examples.

Clinical tests are not involved in the process of evaluation of such medical instruments, however, a set of requirements has to be met in order to approve the products.

Class C – Moderate to high risk

Sophisticated devices may pose a serious yet not fatal threat to a patient’s health if operated without the necessary expertise. X Rays, ECGs, in-patient monitoring systems, orthopedic implants, contact lenses, oximeters, and many other devices fall under this class.

The products will have to go through a complex evaluation that includes risk analysis, and the producer is expected to provide security facts. Nevertheless, clinical tests are still not needed.

Class D – High risk

Unprofessional manipulation and usage of these products and devices can result in serious or fatal consequences for the patient or medical staff.

CT scans, MRIs, cardiac catheters, cardiac stents, HIV tests, pacemakers, dermal fillers, and many other medical instruments pose a high risk and therefore have to go through a long process of evaluation before they can be distributed.

In addition, clinical tests, articles in published journals, and risk analysis have to be executed and security facts provided to ensure a smooth approval.

Please note that the evaluation is subject to a charge. The amount depends on the class assigned, and it is due before proceeding further with the paperwork.

Distribution of Medical Devices License (Nomor Izin Edar)

Even the registered products cannot be considered for the Indonesian market unless you are granted the Distribution License for Medical Devices (NIE).

The NIE guarantees compliance with labeling and packaging requirements and ensures meeting specific conditions that are different for each class as well as special conditions that might be set for selected devices. In general, an e-report regarding your product should be submitted every 6 months.

Besides the basic information such as product name, batch number/production number, expiry date, etc., also additional data about manufacturer and distributor should be provided.

Main components of the device, indication for use, and any necessary warnings and precautions that should be taken when manipulating the product are other data that must not be omitted.

Ministry of Health also requires the translation of related texts from the original language into Indonesian.

As the conditions vary a lot for different types of products, it might be an uneasy task to follow the compliance and not to fall behind schedule when it comes to red tape.

You should consider an experienced company such as Cekindo to be in charge to make sure the legal proceedings go as smoothly as possible.

Post-market Entering Control

After the product is launched, it remains under the control of authorities in charge. Monitoring is conducted according to the ASEAN AMDD guideline, and it includes sampling, vigilance, and advertising in order to ensure permanent quality.

To find out more about opportunities the Indonesian boosting healthcare sector may offer to you or for help with establishing your product within the local market, please contact Cekindo.

Our experts will guide you through medical product registration in Indonesia.

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