Home About Qualtech NEWS 6 Things You Have to Know When Registering Your Medical Device in Indonesia - January 2019
6 Things You Have to Know When Registering Your Medical Device in Indonesia - January 2019

January 15, 2019

Indonesia, with a big medical device market, attracts many foreign medical device companies. Getting a Marketing Authorization License represents the first step for a company who wants to sell their medical device on the Indonesian market. Yet, the unavailability of guidance/regulations in English, may represent quite a challenge for foreign companies who would like to understand the specific requirements in Indonesia. Below we have summarized 6 key important aspects that foreign companies may take note of when being interested in registering their medical device in Indonesia.

1.  Is it allowable to assign different distributors to register the same product?

It’s common for some companies to put their company name as the medical device brand name. However, you may need to take note that in Indonesia, the products that have the same brand name and that fall in the same category, can only be registered by 1 distributor.

To illustrate this point, simply consider the following example: A company with the name “ABC” produces medical devices that belong to the Orthopaedic category with brand “ABC” Knee Implant and “ABC” Bone Graft. These two products must then be registered under the same distributor, since they have the same Brand Name and belong to the same medical device category.

2.  Can we use another brand name different to the name on the Free Sales Certificate?

Getting a Free Sales Certificate (FSC) from the country of origin is a mandatory requirement for medical device registration. Due to business strategy concerns, some foreign companies would like to register under a different brand name in Indonesia. However, this strategy is not allowed in Indonesia. The product name that will be registered in Indonesia, must be the same as the one written in the FSC.

Following the above example, if the product’s name on the FSC is“ABC” Bone graft, then the product name must be “ABC” Bone graft throughout the registration process as well.

3.  Can we group many different models into a single license?

Medical devices with different specifications cannot be registered under 1 license. Only models with solely different dimensions, or medical devices that work in closed system, are allowed to be registered under 1 license.

Below are a number of examples to help you understand the grouping concept:

Case 1: Consumable devices – a surgical mesh has different sizes with different model names. These can be grouped in one license.

Case 2: Active devices – Most of the time, it is very difficult to have active devices being grouped in 1 application. If the device has different parameters with different model names, then it is extremely hard to group them into a single license.   

4.  When does the manufacturer need to provide a Clinical Evaluation Report?

Based on the Indonesian risk classifications, there are four product levels with regards to the registration process. Namely, class A, B, C, and D. For Class D products only, a Clinical Evaluation Report (CER) is mandatory.

If your product has obtained a CE mark, you might already have a CER from the CE marking. In fact, the CER from the CE marking is being accepted by Indonesia’s MoH. However, in case you are lacking a CER for your product, you can search for similar products on the market as well as their relevant clinical studies to prepare for your own CER. These similar products, that are already on the market and which may serve as your reference, of course do not necessarily have to be on the Indonesian market.

5.  Can we submit in-house test reports or 3rd party test reports for registration?

In general, the MoH will a accept the submission of in-house test reports or 3rd party test reports. However, there are special conditions for some products to be noticed. Based on the registration guidance, the following products must undergo local tests in Indonesia to ensure their safety and performance:

a.       Syringes: A sterilization test is required;

b.      Condoms: A fatigue test is required;

c.       For gauze, absorbent cotton, adult diapers, sanitary napkins, panty liner: An absorbency and fluorescence test is required;

d.      Disinfectant devices: A phenol coefficient test is required.

6.  In what situations can one apply for a license amendment application?

Only the changes specified as follows are being treated as ‘amendments’: Size, packaging, labelling, accessories/attachments in the license, name/address of the legal manufacturer that is not an acquisition and there is no change in manufacturer address, other changes that are not influencing the specification and performance of the medical device.

It is worth to note that a change in the medical device distributor will be treated as a new application. However, the new application by the new distributor can only be done, after the manufacturer has issued a “Termination Letter” to the previous distributor and has further provided a “Letter of Authorization” to the new distributor, respectively. Also, the previous distributor must submit a “No Objection Letter” together with the “Marketing Authorization License” to the Ministry of Health prior to the new registration by the new distributor.

 

Reference:

1.    Peraturan Menteri Kesehatan Republik Indonesia Nomor 62 Tahun 2017 tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Rumah Tangga

2.    Pedoman Bimbingan Teknis Perizinan Alat Kesehatan 2016

 

 

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Home About Qualtech NEWS 6 Things You Have to Know When Registering Your Medical Device in Indonesia - January 2019