The registration process for B-class in vitro diagnostic (IVD) medical devices with Malaysia's Medical Device Authority (MDA) involves several key steps, including pre-application preparation, documentation submission, and post-market compliance. Here’s a detailed outline of each phase:

1. Confirm Device Classification

• Verify that your IVD device qualifies as a Class B device, which is defined as a low to moderate-risk IVD device. The MDA classification system is based on intended use, potential risk, and degree of invasiveness. If unsure, consult MDA guidelines or seek assistance from a regulatory consultant.

2. Pre-Application Preparation

• Appoint a Local Authorized Representative: If the manufacturer is not based in Malaysia, designate a Malaysia-based authorized representative who will handle regulatory compliance, documentation submission, and post-market requirements.
• Establish a Quality Management System (QMS): Implement an ISO 13485-certified QMS, as this is a standard MDA requirement. Evidence of QMS compliance is often necessary for device registration.
• Collect Device-Specific Documents: Prepare a comprehensive technical file with the following documents:
  • Device Description: Clearly state the device’s intended use, components, and function.
  • Safety and Performance Data: Include clinical and non-clinical data showing device safety and efficacy.
  • Risk Management Report: Conduct a risk assessment and provide documentation of risk control measures.
  • Labeling and Instructions for Use (IFU): Include all labeling, instructions, and indications for proper device usage.
  • Declaration of Conformity: A document that confirms the device meets applicable regulatory requirements.
  • Manufacturer Information: Include details on the device manufacturer and any subcontractors.

3. Register in the Medical Device Information and Safety System (MeDISS)

• Create an Account on MeDISS: Access the MDA’s online registration portal, the Medical Device Information and Safety System (MeDISS), to initiate your application. If new to MeDISS, you’ll need to create an account.
• Complete the Online Application: Fill out the application form accurately, including device classification, technical specifications, and supporting documentation.
• Upload Required Documents: Attach the previously prepared documents in digital format, ensuring each is accurate and complete.

4. Submit Fees

• MDA imposes a fee for Class B device registration. The amount may vary depending on factors like the device type and application complexity. Be sure to review the latest MDA fee guidelines.

5. Assessment and Technical Review by MDA

• MDA will review your submission, which includes verifying device classification, documentation, and conformity with regulatory standards.
• Respond to Additional Information Requests: MDA may request clarifications or further information during their assessment. Respond promptly to avoid delays in processing.

6. Approval and Registration Certificate Issuance

• Once the application is approved, MDA will issue a registration certificate, allowing the Class B IVD device to be marketed in Malaysia.
• The certificate is generally valid for a specified period, after which it must be renewed to maintain market authorization.

7. Post-Market Surveillance and Compliance

• After registration, the device must comply with Malaysian post-market requirements, which include:
  • Adverse Event Reporting: Report any adverse events or malfunctions associated with the device to MDA.
  • Field Safety Corrective Actions (FSCA): If necessary, implement safety measures like product recalls, field corrections, or updates to labeling and IFUs.
  • Renewal of Registration: Submit a renewal application before the registration certificate expires to ensure continuous market access.

Additional Tips for a Smooth Process

• Stay Updated on Regulatory Changes: Regularly check MDA’s official guidelines for any updates on regulatory requirements.
• Maintain Clear Documentation: Accurate and detailed documentation reduces delays during the review process.
• Seek Regulatory Expertise: Engaging a regulatory consultant or local representative experienced with MDA can streamline the registration process.

Following these steps will ensure compliance with Malaysian regulations, and proper planning can help achieve a smooth registration process.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn