Medical Devices Standards
GDPMD Good Distribution Practice for Medical Devices
With the effective date (1 July 2013) of Act 737 and Medical Device Regulations 2012, manufacturers and distributors of medical devices are required to apply for their establishment licence to continue carrying out their manufacturing, distribution or importing activities. Manufacturers require ISO13485 Medical Devices Quality Management System certification whereas Distributors and Importers require Good Distribution Practice for Medical Devices (GDPMD) certification prior to applying for their Establishment Licence. There is a transition period of two years and one year respectively for the industry to submit applications for medical devices product registration and...
Read MoreISO 13485 Medical Devices Quality Management System
ISO 13485 ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The standard is applicable to all manufacturers and providers of medical devices, components, contract services and distribution of medical devices. Similarly with ISO 9001, the main requirements consist of: Clause 4: Quality management system Clause 5: Management responsibility Clause 6: Resource management Clause 7: Product realization Clause 8: Measurement,...
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