When registering a B-class in vitro diagnostic (IVD) medical device with Malaysia's Medical Device Authority (MDA), manufacturers must comply with various standards that ensure the safety, quality, and performance of the device. Here’s an overview of the relevant standards and regulations:

1. ISO 13485:2016

• Quality Management Systems: This international standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Compliance with ISO 13485 is mandatory for manufacturers of medical devices in Malaysia.

2. ISO 14971:2019

• Risk Management: This standard outlines the process for risk management in medical devices. It provides a framework for identifying hazards, estimating and evaluating risks, controlling these risks, and monitoring the effectiveness of the controls. A risk management report in compliance with ISO 14971 is required as part of the technical documentation for the registration.

3. ISO 15189:2012

• Medical Laboratories: This standard specifies requirements for quality and competence in medical laboratories. If the IVD device is intended for use in a laboratory setting, compliance with ISO 15189 may be applicable, especially for clinical testing facilities.

4. ISO 17511:2003

• Metrological Traceability: This standard specifies the requirements for establishing metrological traceability for IVD test results. It is essential for ensuring that the results obtained from an IVD device can be traced back to national or international measurement standards.

5. ISO 20695:2018

• In Vitro Diagnostic Devices: This standard provides guidelines for the evaluation of in vitro diagnostic devices. It covers the performance evaluation and validation processes necessary to demonstrate the effectiveness and reliability of IVD devices.

6. EN ISO 13485:2016

• European Norm for Medical Devices: Although primarily focused on the European market, many manufacturers adopt EN ISO standards to ensure compliance with international best practices.

7. Malaysian Medical Device Regulations 2012

• Regulatory Framework: The registration process is governed by the Medical Device Act 2012 and its associated regulations. This includes guidelines on classification, registration, post-market surveillance, and quality control for medical devices in Malaysia.

8. Guidelines on the Registration of Medical Devices

• MDA-Specific Guidelines: The MDA has published specific guidelines for the registration of medical devices, including IVDs. These guidelines detail the application process, technical documentation requirements, and compliance with relevant standards.

9. Clinical Evaluation Standards

• Relevant Guidelines: Depending on the device, clinical evaluation may be required as per MDA's guidelines. This evaluation must comply with standards such as the Medical Device Regulation (MDR) or IVD Regulation (IVDR) if the device is intended for European markets.

Summary of Relevant Standards for B-Class IVD Registration

1. ISO 13485:2016 - Quality Management Systems
2. ISO 14971:2019 - Risk Management
3. ISO 15189:2012 - Medical Laboratories
4. ISO 17511:2003 - Metrological Traceability
5. ISO 20695:2018 - Evaluation of In Vitro Diagnostic Devices
6. EN ISO 13485:2016 - European Norm for Medical Devices
7. Malaysian Medical Device Regulations 2012 - Regulatory Framework
8. MDA-Specific Guidelines - Registration Procedures
9. Clinical Evaluation Standards - Relevant guidelines as necessary

Compliance with these standards is essential for the successful registration of B-class IVD medical devices with MDA, ensuring that the devices are safe, effective, and meet regulatory requirements.

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