Trusted by Medical Experts

Nope, as it’s charged by another 3rd party independent audit firm. 

1st year: RM6,000

2nd & 3rd year: RM4,000

4th year (re-cert year): RM6,000

It’s ± RM1500. 

5 years, just like the product license. 

Application fee + License Fee

Class A: RM500 + RM750 = RM1250

Class B: RM250 + RM1000 = RM1250

Class C: RM500 + RM2000 = RM2500

Class D: RM750 + RM3000 = RM3750 

New application
AR = RM4250
Distributor = RM2250
Importer = RM2250

Renewal
AR = RM2200
Distributor = RM1200
Importer = RM1200

For GDPMD: every year

For Establishment License: 3 years

For Product License: 5 years 

Upon confirmation and pay 10 days before the commencement: 

• Step 1: Pay for GDPMD Consultation 
• Step 2: Pay for Medical Device Registration Consultation

PS: Travelling allowance will be bare by client for out-of-Klang Valley consultation project.

1. Awareness training 
2. Internal audit training
3. Documentation 
4. Management review 

Yes we do. You can come back to us when you are going for 2nd year audit. 

Fee: RM5,900 + 8% SST / project

Duration: 2 days / project 

Maintenance package is inclusive of: 

a) review the readiness of the “audit documentation” for the upcoming assessment

b) assist on reflecting any changes / amendment that is necessary for documentation and process

c) advise / rectify any issue arise from previous assessment internally/externally

d) assist on conducting the internal audit

e) coordinate the audit between client & CAB

f) assist on replying NC (if any) followed with the Corrective Action implementation

Yes we do. You can come to us for this service. 

Fee:
1. Class A: RM5000 + 8% SST

2. Class B, C, D: RM9000 + 8% SST 

GDPMD stands for Good Distribution Practice for Medical Devices. It is a regulatory requirement that ensures medical devices are properly stored, handled, transported, installed, and distributed while maintaining their quality, safety, and performance throughout the supply chain.

GDPMD provides a systematic approach to control distribution activities and ensures medical device companies comply with Malaysia’s Medical Device Authority (MDA) requirements.

GDPMD is important because medical devices must maintain their intended performance and safety from the manufacturer until they reach the end user.

A proper GDPMD system helps companies:

• Maintain product quality and integrity.
• Ensure traceability of medical devices.
• Control storage and transportation conditions.
• Reduce regulatory risks.
• Build customer and healthcare industry confidence.

GDPMD stands for Good Distribution Practice for Medical Devices.

It focuses on controlling the distribution process of medical devices, including:

• Purchasing activities.
• Receiving and inspection.
• Storage.
• Transportation.
• Delivery.
• Complaint handling.
• Product recall.

Companies involved in the supply chain of medical devices may require GDPMD compliance, including:

• Medical device importers.
• Medical device distributors.
• Authorized representatives.
• Wholesalers.
• Warehousing companies.
• Logistics providers handling medical devices.

The requirement depends on the company’s activities and responsibilities under Malaysia’s medical device regulatory framework.

Yes. GDPMD compliance is part of the regulatory requirements for applicable medical device establishments registered with the Medical Device Authority (MDA).

Companies involved in importing and distributing medical devices need to demonstrate compliance with GDPMD requirements to maintain regulatory approval.

GDPMD requirements cover several key areas, including:

• Quality management system.
• Organization responsibilities.
• Personnel competency.
• Documentation control.
• Purchasing control.
• Storage and warehouse management.
• Transportation control.
• Traceability.
• Complaint handling.
• Product recall.
• Internal audit.
• Corrective and preventive action.

Typical GDPMD documentation includes:

• Quality Manual.
• Quality Policy.
• Organization chart.
• Standard Operating Procedures (SOP).
• Work instructions.
• Distribution records.
• Warehouse procedures.
• Complaint handling procedures.
• Recall procedures.
• Training records.
• Internal audit reports.
• Management review records.

The exact documents depend on the company’s business scope.

Yes. GDPMD requires companies to establish and maintain a documented quality management system suitable for their distribution activities.

The QMS ensures processes are controlled, monitored, and continuously improved.

GDPMD auditors typically evaluate:

• Documentation control.
• Warehouse condition.
• Product identification and traceability.
• Storage practices.
• Transportation control.
• Supplier management.
• Employee competency.
• Complaint management.
• Recall readiness.
• Internal audit effectiveness.

Common nonconformities include:

• Incomplete SOP documentation.
• Poor document control.
• Lack of employee training record.
• Inadequate temperature monitoring.
• Poor warehouse housekeeping.
• Missing traceability record.
• Weak complaint handling processes.
• Ineffective internal audit.

A typical GDPMD implementation process includes:

1. Initial gap assessment.
2. Develop implementation plan.
3. Prepare GDPMD documentation.
4. Train employees.
5. Implement procedure.
6. Conduct internal audit.
7. Perform management review.
8. Prepare for certification audit.

The implementation timeline depends on:

• Company size.
• Number of warehouses.
• Existing quality system.
• Number of employees.
• Business complexity.

Generally, GDPMD implementation may take approximately 2 to 4 months for companies with proper support and commitment.

Yes. SMEs can implement GDPMD.

The system can be designed according to the company’s size, operational complexity, and distribution activities while still meeting regulatory requirements.

Yes. New medical device companies can establish GDPMD compliance as part of their business setup before starting distribution activities.

Early implementation helps companies avoid future compliance issues.

Yes. GDPMD can be integrated with ISO 9001 because both standards focus on quality management principles.

Companies with ISO 9001 certification may find GDPMD implementation easier because some management system elements are already established.

GDPMD focuses on medical device distribution activities, while ISO 13485 focuses on the quality management system for medical device manufacturers and related organizations.

GDPMD covers:

• Storage.
• Handling.
• Transportation.
• Distribution.

ISO 13485 covers:

• Design.
• Manufacturing.
• Production control.
• Medical device quality management.

GDPMD applies specifically to medical devices, while GDP (Good Distribution Practice) is commonly associated with pharmaceutical products.

Although both control distribution activities, their regulatory requirements and focus areas are different.

Not every distributor requires ISO 13485.

The requirement depends on the company’s role, regulatory responsibilities, and business activities. A proper assessment should be conducted before deciding which certification is required.

A GDPMD audit normally includes:

1. Document review.
2. Site assessment.
3. Interview with employees.
4. Review of records.
5. Evaluation of operational practices.
6. Identification of nonconformities.

Preparation includes:

• Completing internal audits.
• Ensuring SOP implementation.
• Training employees.
• Checking warehouse compliance.
• Reviewing documentation.
• Correcting potential gaps before the audit.

If a company does not meet GDPMD requirements, corrective actions are required.

The company needs to address identified nonconformities before certification approval can proceed.

Anyway, you can still refer back to us as the GDPMD consultant. 

If a company does not meet GDPMD requirements, corrective actions are required.

The company needs to address identified nonconformities before certification approval can proceed.

Anyway, you can still refer back to us as the GDPMD consultant. 

GDPMD compliance requires continuous maintenance.

Companies should regularly perform:

• Internal audit.
• Training update.
• Document review.
• Process improvement activities.

A professional GDPMD consultant can help companies:

• Understand regulatory requirement.
• Identify compliance gap.
• Develop practical documentation.
• Reduce implementation time.
• Prepare for successful audit.
• Avoid common mistake.

A good GDPMD consultant should have:

• Experience with medical device regulation.
• Knowledge of MDA requirement.
• Practical industry experience.
• Proven consulting methodology.
• Ability to provide implementation support.

Companies can implement GDPMD internally, but experienced consultants can help accelerate the process, provide regulatory insight, and reduce trial-and-error during implementation.

Companies involved in importing medical devices should evaluate their regulatory responsibilities because import activities may require compliance with GDPMD requirement.

Storage activities are an important part of medical device distribution. Companies responsible for storage conditions should ensure compliance with applicable GDPMD requirements.

The scope of GDPMD coverage depends on the company’s operational structure and certification arrangement. Multiple location should be properly assessed and controlled.

Non-compliance may result in regulatory issues, including difficulties maintaining establishment licensing and potential business limitation.

The best approach is to conduct a thorough gap analysis, implement effective procedure, train employees, perform internal audit, and ensure operational practices match documented procedure.

Industries commonly requiring GDPMD include:

• Medical device distributor.
• Healthcare supplier.
• Hospital equipment supplier.
• Laboratory equipment supplier.
• Medical technology companies.
• Healthcare logistics provider.

GDPMD helps companies establish stronger operational control, improve customer confidence, enhance regulatory compliance, and create a more reliable medical device supply chain.

The first step is to conduct a GDPMD gap assessment. This identifies your current compliance level and creates a roadmap for implementation, documentation, training, audit preparation, and certification.

WhatsApp us at 0175709263 or fill up the form here