Medical Device Authority (MDA) has now withdrawn its Circular Letter No. 1/2014, allowing for certain freedom in appointing more than one authorized representative for each medical device (brand name) placed in the market, while restricting to one license for each role/activity of the economic operators, as prescribed in the Medical Device Regulations 2012. The first part of this new regulation has come into effect since June17, 2021 while the latter will be implemented on a later date.
Previously, the afore-mentioned circular letter established the following for the first component, whereby only one authorised representative shall represent any medical device (brand name) imported and placed on the Malaysian market. However, shall this condition be met, overseas manufacturers with a large number of medical device items to import and sell in Malaysia may appoint more than one authorised representative.
As for the circular letter's second component, it allowed establishments that carried out multiple economic operator activities to do so with these scopes covered under one establishment license. For example, an organization working as a (local) medical device manufacturer may also distribute medical devices under the same license, while an authorised representative may carry out the distribution and importation of medical devices that have been authorized under the same license. Furthermore, establishments that conduct multiple responsibilities as importers and distributors may operate under the same license for both distribution and importation of medical devices.
With the withdrawal of this circular, MDA will implement the Medical Devices Regulations 2012's policy of one licence per role/activity. Manufacturers, authorised representatives, importers, and distributors can no longer apply a single establishment licence to cover multiple activity scopes.
While the first component of this withdrawn circular letter is now effective, the second component will have to wait until announced on a later date, due to the current COVID-19 situation in the country.