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018-216 6963
What is GDPMD?
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.
Why do you need GDPMD?
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.
Benefits of GDPMD
Meet regulatory and customer requirements.
Fulfilment of establishment licensing requirements.
Demonstrate ability for proper storage, handling, distribution and traceability.
Who will need GDPMD?
Authorised Representative, importer, distributor and logistics providers of medical devices in Malaysia.
Who is ISO 9001 Certification for?
ISO 9001 is suitable to any organization, regardless of size or industry, including service provider.
How Can Flexly Consulting Help?
01
Gap Analysis
Identify the gaps within your company’s current Management System in order to fulfil the best practices set by the international standards.
02
Customised consultation
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 😉)
03
Hassle-free implementation
Assist in developing a straight forward and “easy-to-maintain” management system with minimal documentation.
04
Knowledge Transfer
Provide training and step-by-step guidance to your company personnel in, not just implementing the system, but even maintaining it after getting certified.
05
Internal Audit
We review the compliance of your actual activities to GDPMD requirements and company records prior to your certification body audit.
06
Certification Support
Provide assistance and advice on preparation and external audit by your certification body.
Need Certification Fast?
Many small-medium businesses need quick certification to hit deadlines for proposal submittal, government contracts, and other urgent needs. We pride ourselves on our ability to meet your goals.
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.
01
Who is HRD Corp?
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).
02
Who is eligible to attend training using the HRDCORP / HRDF fund?
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.
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Contact Info
018-216 6963
Flexly Consulting Sdn Bhd, Empire Tower Subang Jaya, Block A, Level 5, Unit 10, Jalan SS 16/1, 47500 Subang Jaya, Selangor.