Sell medical device in Malaysia - Establishment License Application

Starting 1st of January 2018, Malaysia Medical Device Authority (MDA) under the Ministry of Health fully enforces the medical device registration requirements as specified under section 5 of the Medical Device Act 2012 (Act 737) before importing, exporting or placing medical devices in the Malaysian market. From that date onward, all medical devices to be imported, exported or placed in the Malaysian market will need to meet the licensing and other requirements as set out in Section 5 of the Medical Device Act 2012 (Act 737). Also, only the Establishment License Certificate and the Medical Device Registration Certificate are acceptable as supporting documents in the procurement process of medical devices in any health facility institution. [Reference: Notice from Malaysia MDA dated 25th July 2017]

In short, to be legally qualified to sell medical device in Malaysia, you require to apply for:

• Establishment License Certificate (For the registered company that sells medical device); and

• Medical Device Registration Certificate (For each medical device).

So how to do that?

First thing first, you will need to apply for ESTABLISHMENT LICENSE. There are different types of Establishment License, which are:

• Manufacturer License (and Distributor License for own device)

• Authorized Representative License

• Importer License

• Distributor License

Which Establishment License should you have?

Local Manufacturer

Local manufacturer of medical device is the brand owner or legal manufacturer that the business is registered in Malaysia. If you are a local manufacturer of medical device, the quality management system of your company requires to be certified with ISO 13485. With the recognized and valid ISO 13485 certificate, you are eligible to apply for Establishment License for manufacturer (and Distributor License of own device) with MDA through MeDC@St 2.0 (Medical Device Centralized Online Application System)

Foreign Manufacturer

If you are a foreign manufacturer and wish to sell the medical device in Malaysia, you need to appoint a Malaysian company as your Authorized Representative (AR). The Authorized Representative serves as your contact point in Malaysia, and the Authorized Representative is responsible to register the medical device with MDA. You need to issue a Letter of Authorization (LoA) to the appointed AR.

Take note that, each medical device shall only have one Authorized Representative in Malaysia. For example, a foreign manufacturer has three medical device products. The foreign manufacturer can appoint one Malaysian company as the Authorized Representative for all the three products, or, appoint several Malaysian companies as the Authorized Representatives for each product.

Foreign manufacturer is not eligible to apply for Establishment License.

Authorized Representative

As mentioned above, Authorized Representative is the contact point for a foreign manufacturer in Malaysia. To apply for Establishment License as an Authorized Representative with MDA, three steps to go:

1. Obtain Letter of Authorization (LoA) from the foreign manufacturer

2. Certified with Good Distribution Practice for Medical Device (GDPMD) by the Conformity Assessment Body (CAB) recognized by MDA

3. Make application through MeDC@St 2.0 (Medical Device Centralized Online Application System)

Being an Authorized Representative, you are given the authority to import and distribute the medical device as well.

Importer or Distributor

Each medical device shall only have one Authorized Representative in Malaysia, but the medical device can have more than one importers and distributors in Malaysia, provided that the importers and distributors are given authority to import and/or distribute by the Authorized Representative (uhh, not the foreign manufacturer).

To apply for Establishment License as Importer and/or Distributor with MDA, three steps to go as well:

1. Obtain Letter of Authorization (LoA) from the Authorized Representative

2. Certified with Good Distribution Practice for Medical Device (GDPMD) by the Conformity Assessment Body (CAB) recognized by MDA

3. Make application through MeDC@St 2.0 (Medical Device Centralized Online Application System)

With a valid Establishment License, only you can import, distribute and sell the medical device in Malaysia. Ask me for more questions!

Next, let's discuss about Medical Device Registration.