Medical device registration in Indonesia
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.
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.
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.
How to register for your medical device in Indonesia
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.
The Medical Devices Distributor (PAK) that is in possession of the license from the company or business representative and also has the power as a sole agent acknowledged by the local representative of the Republic of Indonesia, with the appointment term of minimum 2 years
In addition, clinical tests, articles in published journals and risk analysis have to be executed and security facts provided to ensure a smooth approval.
The Medical Devices Distributor (PAK) that is in possession of the license from the company or business representative and also has the power as a sole agent acknowledged by the local representative of the Republic of Indonesia, with the appointment term of minimum 2 years
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
