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ISO 13485 Certification in Malaysia

ISO 13485 Certification In Malaysia

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ISO 13485 Certification in Malaysia: Your Ultimate Guide to Success in the Medical Device Industry

When it comes to the medical device industry in Malaysia, ISO 13485 certification stands as a beacon of quality and reliability. This international standard specifies requirements for a quality management system (QMS) that demonstrates the ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. But what exactly does it take to achieve this esteemed certification in Malaysia? From understanding the basics, like “What is ISO 13485 certification?” to navigating the certification process, this blog post will guide you through everything you need to know to successfully certify your business. Let’s get started!

What is ISO 13485 Certification in Malaysia?

ISO 13485 is an internationally recognized standard designed to ensure quality, safety, and efficiency within the design, manufacture, and sale of medical devices. In Malaysia, where the medical device sector is rapidly growing, obtaining ISO 13485 certification is crucial for companies aiming to establish their credibility and gain access to global markets.

How to Get ISO 13485 Certified in Malaysia?

Obtaining ISO 13485 certification in Malaysia involves several key steps:

  • Understand the Standard: Familiarize yourself with the ISO 13485 requirements and how they apply to your business operations.
  • Gap Analysis: Conduct a gap analysis to identify what needs to be improved or changed in your current QMS to meet the ISO 13485 standard.
  • Documentation: Develop the necessary documentation, including quality manual, procedures, and records that meet the standard’s requirements.
  • Implementation: Implement the changes and improvements in your QMS based on the standard’s requirements.
  • Training: Ensure that your staff is adequately trained on the new system and processes.
  • Internal Audit: Conduct an internal audit to check if your QMS complies with ISO 13485 requirements.
  • Management Review: Review the system’s performance and compliance with top management.
  • Certification Audit: Hire a certified body to conduct the certification audit. If you pass, you’ll receive your ISO 13485 certification

ISO 13485 Malaysia Requirements: What Are They?

The ISO 13485 standard in Malaysia requires companies to:

  • Establish a QMS that consistently meets customer and regulatory requirements.
  • Ensure the safe design, development, production, and delivery of medical devices.
  • Maintain effective risk management processes throughout the product lifecycle.
  • Conduct regular audits and reviews to ensure continuous improvement.

Cost of ISO 13485 Certification in Malaysia

The cost of ISO 13485 certification in Malaysia can vary widely depending on several factors, including the size and complexity of your organization, the current state of your QMS, and the certification body you choose. Generally, costs can range from a few thousand to tens of thousands of Malaysian Ringgit.

ISO 13485 Certification in Malaysia

We provide the best ISO Quality Management System For Medical Devices Certification Service in Malaysia!

ISO 13485 specifies requirements in Malaysia for a Quality Management System that can be used by an organisation in Malaysia involved in one or more stages of the life-cycle of medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning, disposal of medical devices, and provision of associated activities in Malaysia.

Medical devices are required to meet certain regulations to be distributed to medical industries of Malaysia. A quality certificate that can assure you are producing and selling devices that are safe is the ISO 13485.


Enhanced Product Quality:

Ensures products are manufactured to the highest standards, increasing customer trust.

Global Recognition:

Opens up international market opportunities, as the certification is internationally recognized.

Regulatory Compliance:

Helps in meeting the legal and regulatory requirements for medical devices in various countries.

Operational Efficiency:

Improves process efficiency and reduces waste, leading to cost savings.

The advantages of obtaining ISO 13485 certification are manifold. Primarily, it assures stakeholders of the quality and safety of products, aligning with global regulatory requirements. It simplifies the pathway to compliance with international market regulations, thereby facilitating global trade. Furthermore, certification can enhance operational efficiency, reduce errors, and foster a culture of continuous improvement.

ISO 13485 Certification

BENEFITS OF ISO 13485 Certification iN MALAYSIA

ISO 13485 Certification

Protection against legal proceedings

Authorities are especially strict when it comes to healthcare regulations. The healthcare sphere is not about second chances, and government bodies need evidence of your complete dedication and conformity to specific standards. By incorporating ISO 13485:2016 requirements into your medical solution, you meet other regulations and fit within the medical products allowed on the market.

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Steps to Obtain ISO 13485 Certification in Malaysia

As outlined earlier, the steps involve understanding the standard, conducting gap analysis, documentation, implementation, training, internal auditing, management review, and finally, undergoing a certification audit.

ISO 13485 vs ISO 9001 Differences in Malaysia

While both ISO 13485 and ISO 9001 are based on quality management principles, ISO 13485 is specifically tailored for the medical device industry, focusing on safety and efficacy. ISO 9001, on the other hand, is more generic and applicable to any industry.

How Long Does ISO 13485 Certification Take in Malaysia?

The time frame for achieving ISO 13485 certification in Malaysia can vary, typically ranging from 2 to 12 months, depending on the organization’s readiness and the complexity of its operations.

ISO 13485 certification requires renewal every three years, with surveillance audits conducted annually to ensure ongoing compliance.


Top ISO 13485 Consultants in Malaysia

Selecting a knowledgeable and experienced consultant can significantly ease the certification process. While specific recommendations can vary, seeking consultants with a strong track record in the medical device sector in Malaysia is essential.

An audit checklist for ISO 13485 in Malaysia should cover areas such as management responsibility, resource management, product realization, and measurement, analysis, and improvement processes to ensure compliance with the standard.

Frequently Asked Questions

ISO 13485 Certification in Australia

What is ISO 13485?

ISO 13485 is an international standard that specifies requirements for a quality management system specific to the medical device industry.

How long does it take to get ISO 13485 certified in Malaysia?

The timeline can vary depending on the organization’s readiness and the complexity of its quality management system, typically ranging from several months to over a year.


How often must ISO 13485 certification be renewed?

ISO 13485 certification typically needs to be renewed every three years, with surveillance audits conducted annually to ensure ongoing compliance.

Why is ISO 13485 certification important for Malaysian medical device companies?

It demonstrates compliance with regulatory requirements, enhances product quality and safety, and facilitates access to international markets.

Can startups in Malaysia obtain ISO 13485 certification?

Yes, startups can obtain ISO 13485 certification in Malaysia, and doing so can provide a competitive advantage by demonstrating a commitment to quality and regulatory compliance from the outset.

What is the cost of obtaining ISO 13485 certification in Malaysia?

The cost varies based on factors such as the size and complexity of the organization, the scope of the quality management system, and the certification body used.

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