Malaysia: MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027)
1. Addition of the clause of post market responsibilities a. Establishment shall:
- Comply to Medical Devices (Duties and Obligations of Establishments) Regulations 2019 that stipulates the post marketing requirements of medical devices; and
- Be responsible for all medical devices that the establishment placed in the market; and
- Carry out responsibilities to monitor and continuously ensure the safety and performance of the medical devices in the market throughout the supply chain.
b. An AR that has been terminated by a manufacturer or closed its business with no replacement shall carry out post-market obligations for the medical devices that it has placed in the market, at least in accordance with the projected useful life of the medical device as determined by the manufacturer.
c. An AR that has closed its business after placing medical device in the market and being replaced by another AR, the newly appointed AR shall be responsible for post market issued of the medical device.
2. Revision on the activities covered by different type of licenses. Each activity will require a separate license. For example, whenever an establishment carries out activities of a manufacturer and as a distributor, the establishment shall be required to obtain both establishment license for manufacturer and establishment license for distributor.
|Fees Mentioned on the First Edition||Fees Mentioned in the Second Edition|
With the new changes mentioned in this second edition of guidance document, it is expected that there will be an increase in cost for the application fees and establishment license fees, especially for new companies involving in different activities.
Please be reminded that all establishments with a valid establishment license shall apply for separate licenses in accordance with its activity, at least 90 days prior to the expiration of their current establishment license.
Further information available Second Edition Guidance Document “Licensing For Establishments” (MDA/GD/0027).
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