Malaysia Issues Final Guideline on Device Registration
Malaysia’s Medical Device Authority has released a six-step guideline on registering devices through the regulator’s web-based system.
Companies should determine whether the product is a medical device under the 2012 device law and then determine its appropriate classification and group. Next, they should conduct a conformity assessment and compile evidence of conformity with MDA regulations in a common submission technical document.
The conformity assessment must be conducted by an approved conformity assessment body. The MDA has approved three thus far: BSI Services Malaysia, SGS and SIRIM QAS. Another seven have applications pending with the agency.
Applications should be submitted through the Medical Device Centralized Online Application System, or MeDC@St, which was launched July 1 to ease compliance with requirements of the 2012 Medical Device Act.
In addition to general manufacturer information, the dossier and declaration of conformity, the MDA asks manufacturers to include a history of the device’s postmarket vigilance history.
Devicemakers should also supply the products recall history, adverse event reports, removal from other markets, if applicable, and any postmarket surveillance studies.
Earlier this year, MDA issued guidelines on good distribution practices.
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