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 establishment licensing before the law is fully enforced, as provided in Section 80, Act 737. (source: www.mdb.gov.my ) The GDPMD requirements consists of 6 parts: Preliminary Organization and GDPMD Regulatory Compliance System Establishment Responsibilities Resource Management Supply Chain and Devi...
