Medical Device Authorized Representative Importance for Market Access

Entry into the medical devices market is not possible without complying with the country or region’s regulations. Especially if you plan to export your products to other countries or regions. Sometimes you also need to appoint a medical device authorized representative to make the process easier.

For some countries and regions, having an authorized representative of a company is a must, like in the European Union (EU).[1] If you want access to the UK, Indonesia, and other countries’ markets, it’s mandatory as well. Some countries and regions make it optional, but having them is definitely easier.

That’s why you have to learn about the meaning of an authorized representative and how important its existence is for a business. In addition, you can find out about regulations for its establishment here, especially in Indonesia!

Medical Authorized Representative Meaning

You are probably wondering about what an authorized representative is. According to the Cambridge Dictionary, it refers to someone who speaks or performs an official role for another person or group.[2] Usually, but not always, from companies that want to enter the market in another country or region.

For example, you have a medical device company in the U.S and want to enter the Indonesian market. So, the first thing you need to do is choose an Indonesian authorized representative in Indonesia. It’s a part of the Indonesian Ministry of Health (MoH) regulation on the import of medical devices.

According to MoH Regulation No. 62 of 2017, you can only enter the Indonesian market by establishing a subsidiary or appointing an authorized representative. They are the ones who will handle everything related to legal matters throughout the import and marketing process.

The Role of Medical Device Authorized Representative

What are the authorized representative's responsibilities for medical devices? You already know that they are responsible for legal and marketing matters, such as:

1. Build Bridges between Manufacturers and Local Authorities

Manufacturers or medical device companies need to communicate frequently with local authorities. However, due to the limitations of distance and time difference, the whole process might be ineffective. Each country or region also has different regulations. So, it tends to be difficult for people abroad.

That’s why you can write a mandate to an authorized representative to comply with the regulation in a specific country or region.

Their role is to:

1. Register the medical devices with the MoH, the Food and Drug Administration, or any other relevant authorities so the products can enter the local market.
2. Handle and keep technical documentation, declarations of conformity, certificates, etc. It must always be ready when the head office requests it.
3. Cooperate with local authorities when needed, for example, when you have to take preventive and corrective actions. Inform the head office directly when authorities’ requests for device samples or other needs arise.

2. Responsible for the Marketing Process in the Country or Region

What is the role of a medical device authorized representative aside from communicating with authorities? A representative is also responsible for the marketing process in the country or region.

Here are things that they should do:

1. Analyze local community demand and import the products.
2. Making sure storage conditions are always good and in accordance with regulations.
3. Storing medical devices before they are distributed.
4. Preparing the means of transport for the distribution process.
5. Distributing products in local markets.
6. Oversee the marketing process.

Report any device-related issues as needed.

Regulation on Medical Device Authorized Representative in Indonesia

If you are planning to enter the Indonesian market, make sure to comply with this regulation after writing a mandate to an authorized representative!

1. Gain a Registration License in accordance with the ASEAN Common Submission Dossier Template.
2. Make sure the products’ quality already meets Indonesian and international standards with a Manufacturer License. You can use ISO 13485:2016.
3. Gain a Medical Devices Distributor License. The person who holds this license will be your authorized representative in Indonesia.
4. Make sure you have all the documents that will be needed, such as:
5. Single Business Identity Number.
6. Company’s Tax Identity.
7. Letter of Authorization (LoA)
8. Free Sales Certificate.
9. ISO 13485 Certificate.
10. Dossier from Manufacturer.
11. Any other relevant documents.

To make it smoother and easier, you can ask Naramedic for help in establishing a medical device authorized representative in Indonesia. We specialize in medical devices to help you obtain a Registration License, Medical Devices Distributor License, etc., with a higher success rate. So, contact us via WhatsApp or email immediately!