Indonesia’s thriving population, growing economy, and still largely underdeveloped health sector make the perfect combination for up-and-coming businesses with medical products.
Currently, the Indonesian government is boosting the local medical device production to encourage increased spending on domestic products. However, due to raw materials and technology limitations, some types of medical devices still depend on imported products.
It brings bright prospects for foreign manufacturers looking for new profitable markets. There is, however, a wide range of precautions anyone considering trading in this highly regulated area should know.
Since domestic production is mostly oriented toward some disposable items, other consumable medical products, high value-added products, and sophisticated devices must be imported.
Regulatory Bodies regarding Indonesia Medical Device Registration
The Ministry of Health of the Republic of Indonesia (MoH) 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 is stated in Article 1 of MoH Regulation No. 62 Year 2017 regarding The Distribution License of Medical Devices, In Vitro Diagnostic and Household Health Supplies issued by the Director General of Pharmacy and Medical Devices of the Indonesian Ministry of Health.
Requirements for Medical Device Registration in Indonesia
Entrepreneurs aspiring to trade medical devices in Indonesia must prove that they are in possession of several licenses before going through the medical device registration in Indonesia with the Ministry of Health. The crucial documents are:
Permanent Business License (Izin Usaha)
Foreign companies cannot distribute medical products in Indonesia unless they establish a limited company with direct foreign investment (PT PMA) or find a local distributor. A permanent Business License issued by Investment Coordinating Board (BKPM) is one of the prerequisites to starting a PT PMA.
Furthermore, to enter the healthcare sector, entrepreneurs should be aware of the Positive Investment List that regulates the maximum percentage of foreign shares in the company. In the healthcare sector, the maximum of foreign shares is 49%.
Registration License (ASEAN Common Submission Dossier Template)
With the harmonization at the level of ASEAN in the field of medical devices and the publication of guidelines for medical devices on the ASEAN Medical Device Directive, Indonesia actively participates in the ASEAN Conformity Committee for Standard and Quality Medical Devices Product Working Group (ACCSQ-MDPWG). The ASEAN Medical Device Directive has been implemented for registering medical devices and household health supplies in Indonesia.
Medical device registration applications must be prepared using the Common Submission Dossier Template (CSDT) format. The ASEAN CSDT document aims to provide a standard template for the submission of medical device information to the regulatory authorities of ASEAN member countries.
Manufacturer License
The license confirms that a product meets both Indonesian and international quality, effectiveness, and safety standards. ISO 13485:2016 is a required certificate for quality management systems. 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 still need to 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 Medical Device Registration Account via 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 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 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
Devices and products that do not present any severe harm if mishandled include medical cotton, bandage, gauze, sanitary pads, walking canes, and more expensive equipment such as wheelchairs or special adjustable beds. This is a vast group, and evaluating these products focuses primarily on their quality and durability.
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
If operated without the necessary expertise, sophisticated devices may pose a severe yet not fatal threat to a patient’s health. X Rays, ECGs, in-patient monitoring systems, orthopedic implants, contact lenses, oximeters, and many other devices fall under this class. These products will undergo 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 severe 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. They, 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 in their origin country cannot be considered for the Indonesian market unless 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 ensure that they meet specific qualities for each product. 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 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 types of products, it might be challenging to follow the compliance and not 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 authorities’ control. Monitoring is conducted according to the AMDD guidelines, and it includes sampling, vigilance, and advertising 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.
