GDPMD Made Simple:
Zero Hassle, Zero Risk, 100% Guaranteed Success

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Benefits of ISO 9001

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Why GDPMD? Who needs 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.

GDPMD is suitable to authorised Representative, importer, distributor and logistics providers of medical devices in Malaysia.

Benefits of GDPMD

Meet regulatory and customer requirements.
Fulfilment of establishment licensing requirements.
Demonstrate ability for proper storage, handling, distribution and traceability.

Getting Certified Easier, Faster & Hassle-free

Skip the guesswork! Our ISO consultant analyzes your business, guiding you step-by-step to ISO certification and standing out from the competition!

Here’s what you’ll get at your 100% free consultation:
  • A gap analysis where we identify the areas for meeting the ISO best practices.
  • A-Z roadmap and the steps you need to take for getting ISO-certified.
  • The fundamentals for making your business ISO-compliant.

Be quick! FREE spots are almost gone for this month!

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100% Certified
or Your Money Back!

Worried about failing your ISO Certification audit? Or concerned about hiring a consultant who leaves you hanging, requiring you to tackle everything solo?

Fear not! We guarantee your certification, or we work for free. It’s a zero-risk investment. If, despite following our guidance, you don’t pass the audit, we’ll refund 100% of your payment, no questions asked!

Flexly ISO Consulting - We make it a whole lot easier, faster and smarter!

DON'T JUST TAKE OUR WORD FOR ITTake A Look At What Our Clients Are Saying

I’m really satisfied & understand very clear in all the explanation given. Top star guidance and support from the team.
Priya RamanJebsen & Jessen Malaysia
Mr Koh had been very professional and helpful since we first engaged him with consult in GDPMD Audit.
Ashley ChenOJC Marketing Sdn Bhd
Absolutely a great pleasure to work with Koh. His company offer complete customised ISO systems for your company. Not "copy pasted" templates. What truly amazed me was I requested for fast certification due to tender requirements, he managed to get everything completed within 1 month. Highly recommend Koh to anyone looking for flexible and fast ISO certification. We will definitely be using his service again!
Dato’ Jacky Lee Director of JJ Mining Resources Sdn Bhd
Overall, I am very pleased working with Mr. Koh for getting my company ISO 9001 certified. My friend recommended him to me. Although he is young, but he is obviously very knowledgeable and his ability to develop the necessary documentation and demonstrate its professionalism assisting us to pass the audit the first time. We’re grateful for his flexibility in his consultation programme keeping the tedious paperwork and documentation to minimum level. One thing I am most happy about is my team did not complain about having more paperwork.
Ken EeDirector of Ee Osteocare & Acupunture Sdn Bhd
We have just completed our external audit with Certification Body and we have passed with no nonconformity's identified. The consultant work diligently to ensure that we have everything we need for our audit and the audit really has transformed from being a very stressful and daunting experience to hassle-free and easy process. Thank you Koh for the help.
Ms. Goh CEO of Hong Long International Group Sdn Bhd
Initially we get ISO certificate just for the sake of meeting customer requirements, apart from that, we didn’t really expect any other benefit out of this project. We didn’t really believe when we were told about how the ISO standard can help improving product quality or company processes. Everything changed after the implementation. We experience less product quality issues and reduced customer complaints. Now we do believe ISO isn’t just a piece of certification. Great job!
Chin YeeDirector of Joy & Wellness Sdn Bhd
The training provided was very thorough and the content was relevant to our industry. Can feel that the trainer did preparation and research about our industry before the training to give more training examples.
Mr. ChiaCBS Enterprise Sdn Bhd
Flexly Consulting - Don't Just Take Our Word For It
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How Can Flexly Consulting Help?

The Top 10 Must-Knows Before Applying GDPMD Certification

01
When is GDPMD required, and why does MDA mandate its implementation?

In Malaysia, GDPMD certification is not only essential for companies involved in medical device distribution but also a prerequisite for obtaining an Establishment License (EL) from the Medical Device Authority (MDA). Under Medical Device Regulation 2012, Establishment License authorizes the company to import, store, distribute, or manufacture medical devices within the country. Companies seeking to apply for an establishment license must demonstrate compliance with GDPMD requirements as part of the licensing process. The certification signifies the company’s adherence to quality distribution practices, strengthening their position in the medical device industry and facilitating regulatory approval for their operations.

02
What knowledge and skills will our team gain from your GDPMD training to excel in medical device distribution and keep up with the latest industry practices?

Our GDPMD training program allows participants gain a deep understanding of GDPMD guidelines, regulatory compliance, risk management, and quality control. The training also covers documentation essentials, ensuring efficient and compliant distribution processes. Moreover, our program keeps your team informed about the latest industry trends and regulatory changes, empowering your organization to maintain a leading position in the medical device distribution sector.

03
Which specific areas does your GDPMD audit cover to enhance our medical device's performance and ensure compliance with regulatory requirements?

Our GDPMD audit assesses your distribution processes, documentation practices, risk management, and quality control procedures. We review your supply chain, storage, handling, and distribution practices to identify opportunities for improvement. Additionally, the audit ensures alignment with GDPMD guidelines, applicable regulations, and industry best practices, resulting in an optimized and compliant medical device distribution system that meets regulatory standards and enhances overall performance.

04
How long does the typical GDPMD certification process take?

The GDPMD certification process involves two parties: the consultant and the certification body (CAB). For the consultant’s part, it typically takes approximately 2 to 4 months to complete the necessary assessments, gap analysis, and implementation of improvements. The certification body’s process usually takes around 1 month to conduct the final audit and issue the certification. However, in special cases, the entire process can be expedited and completed in as little as a month, as demonstrated in a previous case where urgent fulfillment of tender requirements was needed. Our team is dedicated to providing efficient solutions tailored to your specific needs and timeline.

05
How can your experienced GDPMD consultant team help us streamline documentation and maintain compliance with rigorous medical device regulations?

We conduct a thorough review, develop tailored documentation, and provide regulatory guidance to align with GDPMD requirements. Besides, our GDPMD training will enhance your team’s awareness and compliance culture.

06
What are the fees associated with obtaining GDPMD certification?

In Malaysia, to obtain GDPMD certification, you need to appoint two parties: the consultant and the certification body (CAB). The approximate cost for the consultant’s services typically starts from RM 6,000 to RM 9,000, while the certification body’s fees range from RM 3,000 to RM 5,000. However, please note that these costs are provided as a reference and may vary based on factors such as the types of medical devices, business size, and other unique requirements. For an accurate quote tailored to your company’s specific context, please contact our company to receive personalized pricing details.

07
What is the process for a medical device company to obtain GDPMD certification?

The process for a medical device company to obtain GDPMD certification typically involves the following steps:

  1. Engage a GDPMD Consultant: The company appoints a GDPMD consultant to guide them through the certification process and ensure compliance with GDPMD guidelines.
  2. Gap Analysis: The consultant conducts a comprehensive gap analysis to assess the company’s current practices and identify areas that need improvement to meet GDPMD requirements.
  3. Implementation of Improvements: Based on the gap analysis, the company implements necessary improvements to align with GDPMD standards and best practices.
  4. Internal Audit: The consultant performs an internal audit to verify that the implemented changes meet GDPMD guidelines.
  5. Certification Body Selection: The company selects a certification body (CAB) accredited by the Medical Device Authority (MDA) to conduct the final certification audit.
  6. Final Certification Audit: The chosen CAB conducts the certification audit to assess the company’s compliance with GDPMD requirements.
  7. GDPMD Certification: Upon successful completion of the audit, the company is awarded GDPMD certification, demonstrating their adherence to quality distribution practices for medical devices.
08
What factors make your GDPMD services stand out, ensuring efficiency and effectiveness in achieving timely certification for our company?
  1. Industrial Knowledge: Our experienced team possesses in-depth industrial knowledge, understanding the nuances of medical device distribution and compliance requirements.
  2. Fast-Track Implementation Program: We offer a dedicated fast-track program, fully committed to completing the certification project as quickly as possible without compromising on quality.
  3. 100% Certification Guarantee: We are confident in our expertise and commitment to excellence, guaranteeing your company’s successful GDPMD certification.
09
How often do medical device distributors need to be audited for GDPMD compliance?

The company is required to conduct an annual GDPMD internal audit and undergo a surveillance audit from the Certification Body each year.

10
Who is responsible for complying with GDPMD?

The responsibility for complying with GDPMD shall include the authorized representative, importer, distributor, and logistics partners handling warehousing and transportation of the medical devices.

No risks, only results and simplified! We assure 100% success or work for FREE

Say goodbye to uncertainties and trust us to guide you seamlessly through the ISO certification experience.
Your success is not just a goal, it’s our promise.

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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.
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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.

How Can Flexly Consulting Help?