The Good Distribution Practice for Medical Devices (GDPMD) specifies the requirements for a quality management system to be established and implemented by medical device Importer, Distributor and Authorised Representative to comply with Malaysian Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012.
Distributors of medical devices are required to apply for Establishment License from Medical Device Authority (MDA) to carry out their importing, distribution or wholesale activities.
Accordance with Medical Device Regulations 2012, Manufacturers require ISO13485 Medical Devices Quality Management System certification whereas local Authorized Representative, Importer and Distributors, require Good Distribution Practice for Medical Devices (GDPMD) certification prior to applying for their Establishment License.
Authorised Representative, importer, distributor and logistics providers of medical devices in Malaysia.
ISO 9001 is suitable to any organization, regardless of size or industry, including service provider.
Identify the gaps within your company’s current Management System in order to fulfil the best practices set by the international standards.
We believe every business is unique, we customise and deliver our consultation programme according to your business needs (And most importantly, we don’t just hand over the templates to you and let you survive on your own 😉)
Assist in developing a straight forward and “easy-to-maintain” management system with minimal documentation.
Provide training and step-by-step guidance to your company personnel in, not just implementing the system, but even maintaining it after getting certified.
We review the compliance of your actual activities to GDPMD requirements and company records prior to your certification body audit.
Provide assistance and advice on preparation and external audit by your certification body.
100% HRD Corp Claimable.
No Upfront Payment Required.
We are a registered HRD Corp training provider, all of our certification training is claimable under HRD Corp SBL Khas scheme.
Human Resource Development Corporation (HRDCORP), or previously known as Human Resource Development Fund (HRDF) is an agency under the purview of the Ministry of Human Resources Malaysia governed by the Pembangunan Sumber Manusia Berhad Act 2001 (PSMB Act 2001).
All registered employers with HRDF and have paid the levy for the first month of registration are liable to apply for the training grant, subjected to the existing rate of financial assistance and terms and conditions.