Indonesian 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 the 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 prospect 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.
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 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 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 products 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 Products Registration
The entrepreneur aspiring for trading with medical devices in Indonesia must prove that he or she is in possession of several licenses before applying for registration with 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 the 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.
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 purpose.
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 labelling, 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.
Long and highly bureaucratic market entering process has been, to some extent, facilitated by 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 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 that may pose a serious yet not fatal threat to patient’s health if operated without necessary expertise. X Rays, ECGs, in-patient monitoring systems, orthopaedic 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, the 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 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 labelling 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, 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 with the product are another 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 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.
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