Malaysian Regulators Launch MEDCAST, Announce Approved CABs
As previously reported by Emergo Group, the Malaysian Medical Device Authority’s Medical Device Centralized Online Application System (MEDCAST) went live July 1, providing web-based medical device registration, establishment licensing and export permits.
MEDCAST is accessible to medical device manufacturers, importers and exporters, distributors and authorized representatives pursuing medical device registration and approval in Malaysia. After creating a MEDCAST account and completing email validation, an applicant can log in to the system and select which application (Malaysia Medical Device Registration, Establishment License or Export Permit) to fill out online.
In related news, the Medical Device Authority has published its list of certified and pending Conformity Assessment Bodies (CABs) to assess Malaysian market registrants’ ISO 13485 quality system and Good Distribution Practice for medical devices (GDPMD) compliance.
CABs already qualified in Malaysia include BSI Services Malaysia, SGS (Malaysia) and SIRIM QAS International. CABs with pending qualifications include Medcourt Malaysia, TUV SÜD PSB (M) and Care Certification International (M).