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Indonesia strongly depends on imported medical devices to support its healthcare sector. The medical device market in Indonesia may reach USD 5 billion by 2022. The country is also open to foreign ownership of import/export companies and majority foreign ownership of distribution companies.
All these reasons show that Indonesia is a great place to set up a company dealing with medical devices. But companies must first register the medical devices they want to sell. This article details the process and requirements to register medical devices in Indonesia.
Regulations for Medical Devices in Indonesia
The government agency in charge of medical devices and pharmaceuticals is the Ministry of Health. However, there are regulations set by other government agencies as well.
Companies who wish to enter the medical devices market should also follow regulations set by:
- Directorate General of Pharmaceutical Services & Medical Devices
- Directorate of Medical Device Production and Distribution Development.
Definition of Medical Devices
To put it simply, medical devices are instruments, machines, or implants that do not contain drugs that can perform one or more of the following:
- Prevent, diagnose, cure, relieve diseases;
- Treat sick people
- Aid people in health recovery
- Form the structure or correct bodily functions
Classification of Medical Devices
There are 4 classifications for medical devices. The basis for the classification system is the ASEAN Medical Device Directive.
Classification System for Medical Device Based on AMDD (ASEAN Medical Device Directive)
| Classification | Risk Level | Examples |
|---|---|---|
| Class 1 | Low-risk devices would not cause serious harm. The evaluation of these focuses on the quality of the product. | Cholesterol Uric acid test system Surgical instrument Bandage Surgical camera Electric operating table Patient scale |
| Class 2 | Low to moderate-risk devices that can cause a significant but not serious impact on the health of patients. Before distribution, these devices undergo evaluation but do not require clinical evaluation. | Pregnancy self- testing Electric hospital bed Surgical lamp Surgical mask |
| Class 3 | Moderate to high-risk devices that can cause a significant but not serious impact on the health of patients. Before distribution, these devices undergo a more thorough evaluation including risk analysis. These devices do not require clinical evaluation. | Blood glucose self-testing ECG X-ray unit Syringe Condom Contact lenses |
| Class 4 | High-risk medical devices where failure or misuse can result in serious implications for patients or nurses/operators. Before distribution, these devices undergo evaluation including clinical evaluation. | HIV blood donor screening Stent Intraocular lens (IOL) Defibrillator Pacemaker |
How to Register Medical Devices in Indonesia
The Ministry of Health must issue a product distribution number to the company before they can begin trading medical devices. The issuance of the product distribution number is part of the product registration process.
Stages of Product Registration
| Stage | Description | Timeline |
|---|---|---|
| Pre-registration | The Ministry of Health will issue a letter stating the classification of the product. | 15 business days |
| Registration | Evaluation and verification for safety, quality, and efficacy. The Ministry of Health issues the product distribution number at this stage. | 30 business days |
Who can register products in Indonesia?
Only companies established in Indonesia can register products. For medical devices, only a medical device distributor company can register it.
You can open a medical device distributor company if you would like to register the product yourself. Alternatively, you can get a nominee product holder in Indonesia who can hold the product license and register the product on your behalf. Emerhub can act as your nominee product holder.
Documents Required for Medical Device Registration
To register your soft contact lenses, you will need to prepare some documents. These include, but are not limited to:
- Certificate of production of medical device;
- Power of Attorney from the principal/manufacturer to the appointed product holder;
- Medical equipment distribution permit of the appointed distributor;
- Trademark registration proof in Indonesia;
- Device description;
- Manufacturer information;
- Purpose of use according to the manufacturer;
- Indication or a general description of the disease or condition related to the device;
- Functional characteristics or technical specifications of the device;
- Manufacturer’s production standards and device’s compatibility with it;
- Manufacturer’s sterilization process (for sterile medical devices);
- Product packaging with manufacturer and distributor information and product information;
- Instructions or manual for using and maintaining the device
Product Registration for Soft Contact Lenses
Soft contact lenses are quite popular in Indonesia. A research conducted by Euromonitor International says that the demand for daily disposable lenses is growing. Fashion and beauty trends also contribute to the popularity of soft contact lenses.
Soft contact lenses are also medical devices so the process and requirements described above apply to soft contact lenses.
Selling and Importing Medical Devices in Indonesia
Once the Ministry of Health approves the registration and issues the product distribution number, the company can start selling medical devices in Indonesia. If you will be importing the products, you will also need a Surat Keterangan Impor or import approval (SKI).
Do you need help registering a medical device? Talk to us! Send an email to [email protected] or fill out the form below.
