June 12, 2018
MDA has released a new regulatory update, pertaining to Licensing Conditions for All Licensed Establishments under the Medical Device Authority in Malaysia. There have been some critical inclusions to the licensing requirements for all licensed establishments in MDA.
In this latest revision, new clauses related to license amendment and post market issue have been added. On the whole, the new additions provide more explanations on the duties of the licensee, strict regulations the licensee must adhere to and their responsibilities, in terms of post-market traceability and record keeping, while there are also points to be noted about the general requirements to be followed by all licensee. This revised version has come into implementation starting 10th April 2018.
The original document was issued by MDA in the Malay language, which can be consulted here. For everyone’s convenience, Qualtech has translated this document into English and it is available for viewing and download at this link.