Product Registration > The Ministry of Health (MOH)

This general definition is stated in Regulation No. 1190/MENKES/PER/VIII/2010 article 1 and 3. Governing medical devices and household products further specified in the documents issued by the Directorate of Production and Distribution of Medical Devices and the Directorate General of Pharmaceutical and Medical Devices.

The Food and Drug Administration (BPOM) is another government institution responsible for overseeing health products. Its role is to evaluate whether all products meet the requirements to enter the Indonesian market. In addition, the purpose of this surveillance is to ensure quality and safety, increase availability and ability to purchase health products throughout Indonesia.

Foreign companies are not allowed to do business selling health products in Indonesia unless they set up PT PMA or find a local distributor. Fixed Business License issued by the Investment Coordinating Board (BKPM) is one of the prerequisites to run PT PMA. In addition, if you want to do business in the healthcare sector, you should be aware of a Negative Investment List that sets the maximum percentage for foreign shares in companies in various fields, including healthcare, where the maximum foreign shares are 49 percent.

Indonesia has followed the registration policy of ASEAN countries, which means medical device applicants are required to pass on a lot of information to the authorized ASEAN authorities. Common Submission Dossier Templates (CSDT) is a platform for registering with the Health Sciences Authority (HSA) responsible for this.

This business license ensures that health products meet Indonesian and international standards with respect to quality, effectiveness and safety. This is an international certificate governed by ISO 13485 issued on March 1, 2016 by ISO that handles medical devices, quality management systems and requirements for regulatory purposes.

IPAK is published based on the usefulness of the medical device in question. Manufacturing Business License that has been discussed before must be obtained first before applying for IPAK. Medical devices can be classified as one of the following categories:
1. electromedic radiation
2. electromedic without radiation
3. non electromedic sterile
4. non electromedic non sterile
5. in vitro diagnostic products

After obtaining all of the above permissions and when submitting any other required documents (declaration of conformity, manufacturing information, tool description, tool labeling, design verification and validation, etc.), the Ministry of Health will approve your registration. However, a few more steps must be taken before you can sign your first business deal

The bureaucratic process of entering the market has been facilitated, to some extent, by the alignment of regulations in Indonesia with regulations applied by other countries in ASEAN under the ASEAN Medical Device Directive (AMDD). In addition, AMDD has brought changes to the classification of health products based on risks that could arise if not handled appropriately. The previous three categories have been replaced with a four-group evaluation system.

Group A – Low risk

Products and medical devices that do not present serious harm if misused, such as cotton, bandages, gauze, sanitary pads, walking sticks and more expensive tools such as wheelchairs or special mattresses. The products and medical devices included in this group are very broad, and the evaluation focuses primarily on quality and/or durability.

Group B – Low to moderate risk

Products and medical devices that can impact the patient's health in case of malfunction or improper use. Included in this group are hospital electric mattresses, surgical masks and gloves, syringes, hemodialysis fluids and much more. Clinical trials are not involved in the evaluation process of health instruments. However, a set of requirements must be met for product approval.

Group C – Medium to high risk

Modern tools that may have a serious but not fatal impact on a patient's health if operated without the necessary knowledge. X Rays, ECGs, inpatient monitoring systems, orthopaedic implants, contact lenses, oximeters and many other devices are included in this golongsn. These products must go through a complex evaluation process, including risk analysis, and the product maker must provide safety facts. However, clinical trials are still not required.

Group D – High risk

Unprofessional use of medical products and devices in this group can be fatal for patients or medical staff.
CT scans, MRIs, cardiac catheters, heart stents, HIV tests, pacemakers, dermal fillers and many other health instruments pose a high risk. Therefore, it takes a long evaluation process before they can be distributed.

In addition, clinical trials, articles published in journals and risk analysis should be conducted and safety facts should be presented to obtain approval smoothly. Keep in mind that evaluations are charged. The amount depends on the group, and must be paid before taking care of the documents.

Products that have been registered cannot even be considered for the Indonesian market unless you have obtained a Circulation License Number (NIE). NIE guarantees compliance with labeling and packing requirements and ensures that certain different conditions for each class as well as specific conditions for specific tools have been met. In general, electronic reports about your product should be submitted every 6 months.

In addition to basic information such as product name, production number, expiration date, etc., additional data on manufacturing and distributors must also be presented. .

The main components of medical devices, indications of usefulness and warnings and prevention that are deemed necessary when using the product should also be included. .

The Ministry of Health also requires the translation of related text from the original language to the Indonesian language.

Once the product is launched, it will still be supervised by the relevant authorities. Monitoring is conducted in accordance with ASEAN AMDD guidelines, and this includes sampling, monitoring and advertising to ensure permanent quality.