Jul 16, 2020
Asia
The Medical Device Authority (MDA), a branch of the Ministry of Health Malaysia responsible for medical device regulation, issued guidance documents dedicated to handling complaints, and mandatory problem reporting. Regulatory Background The Malaysian regulating...
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Jul 14, 2020
Asia
The Medical Device Authority (MDA), a special body of the Ministry of Health Malaysia responsible for medical device regulations, issued guidance on field corrective actions. Malaysian Medical Devices Regulatory Background The present MDA guidance is intended to...
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Jan 2, 2020
Uncategorized
The Medical Device Authority (MDA), a special division of the Ministry of Health Malaysia responsible for medical device regulation, has announced new rules introducing additional obligations for medical device manufacturers and other parties involved in medical...
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Jun 18, 2018
Asia
Malaysia’s Medical Device Authority (MDA) has announced that the registration requirements laid out in the Medical Device Act 2012 will go into effect on July 1, 2018. At the end of 2017, the agency extended its moratorium on the enforcement of the Act to July...
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