Malaysia: MDA Allow Registration of a Medical Device by Multiple AR

ARQon
Dec 17, 2021
2 min read

MDA has announced that Circular Letter No. 1/2014 has been revoked effective 17 June 2021 in accordance with the decision made in the MDA Meeting No. 2/2021.

Two components of Circular Letter No. 1/2014

1. Establishment acting as an authorized representative (AR). The circular authorizes:

a) Each medical device product imported and placed on the Malaysian market shall be represented by only one authorized representative; and

b) Foreign manufacturers who have many medical device products to be imported and placed in the Malaysian market may appoint more than one authorized representative by fulfilling condition (a) above.

With this revocation of circular letter, MDA no longer limits to only one AR that can import and place medical devices in the Malaysian market and allows the registration of a medical device by multiple authorized representatives (Multiple AR) by meeting the requirements under Section 5 and Section 15 Medical Devices Act 2012 (Act 737).

2. Establishment that carries out various activities. The circular authorizes:

a) An establishment acting as a manufacturer of a medical device may carry out its medical device distribution activities under the same license;

b) An establishment acting as an authorized representative may carry out the activities of distribution and importation of medical devices delegated to it under the same license; and

c) Establishments that carry out a combination of roles as importers and distributors may carry out the activities of distribution and importation of medical devices under the same license.

With the revocation of this circular, MDA will implement the policy of one license for each role/activity as stipulated in the Medical Devices Regulations 2012. Establishments can no longer combine license applications for the activities of manufacturers/authorized representatives/importers and distributors under one common license.

However, taking into account the situation of the Covid-19 pandemic in the country, the implementation of this second component has been delayed and will be implemented on a date to be determined later.

Sources:

Revocation of MDA Circular Letter No. 1/2014