Full Conformity Assessment (FCA) and Technical Documents Verification (Product Verification - PV)

Supporting manufacturers with MDA regulatory compliance

At DNV Malaysia, we provide Full Conformity Assessment (FCA) and Technical Documents Verification (Product Verification - PV) services in line with the Medical Device Authority Malaysia (MDA) requirements under Act 737. Our services support manufacturers in meeting compliance with MDA codes, including MD 0101, MD 0102, MD 0104, MD 0106, MD 0107, MD 0108, MD 0301, MD 0302, and MD 0303.

By working with DNV, medical device manufacturers can ensure their products are assessed for the required safety and quality standards for the Malaysian market. Our expert assessments provide clarity and accuracy, helping you navigate the regulatory process efficiently.

How DNV Malaysia supports your compliance journey

With a strong understanding of regulatory frameworks and global best practices, DNV provides structured assessment of compliance and a structured assessment process to help manufacturers streamline their certification and approval processes. Our key services include:

• Full Conformity Assessment (FCA): Ensuring medical devices meet MDA (Malaysia) requirements for safety, effectiveness, and regulatory compliance.
• Technical Documents Verification (Product Verification - PV): Conducting detailed assessments of technical documentation in compliance with MDA codes and international standards.
• Regulatory guidance & documentation support: Helping manufacturers navigate MDA certification and submission processes.
• Independent verification & product testing: Validating that devices comply with safety and performance standards before market release.
• Risk assessment & impact analysis: Identifying potential risks and corrective measures to maintain compliance and product integrity are embedded in the conformity assessment process
• Ongoing compliance monitoring: Providing continuous surveillance to verify medical devices remain compliant throughout their lifecycle.

Why DNV?

• MDA-recognized expertise: We have extensive knowledge of MDA Malaysia’s regulatory framework, ensuring a smooth certification process.
• Independent, trusted assurance: Our third-party verification enhances credibility and regulatory trust in your products.
• Global expertise, local understanding: With operations in over 100 countries, we offer a combination of international best practices and local regulatory insights.
• Proven track record in medical device safety: Decades of experience supporting manufacturers in achieving regulatory compliance worldwide.
• Combined services: Conformity assessment process can be shared with other regulatory requirements such as the European medical device regulations (MDR), reducing cost and burden of certification.

Partner with DNV 

Navigating MDA Malaysia’s regulatory requirements can be complex, but you don’t have to do it alone. Partner with DNV to verify that your medical devices are compliant, safe, and ready for the market.

Contact us today to learn how our expertise can support your business.