For B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA), specific materials and documentation are required to demonstrate compliance, safety, and performance of the device. Here’s a detailed list of required materials and a guide to preparing the application documents.

Required Materials for Class B IVD Registration

1. Device Description:

   • Clearly describe the device, including its intended use, target population, and how it works.
   • Include details about the design, components, and any variations or configurations of the device.

2. Risk Management Report:

   • Prepare a risk assessment according to ISO 14971, documenting all potential risks, their likelihood, and mitigation strategies.
   • Describe any residual risks after mitigation and justify their acceptability.

3. Performance Evaluation and Testing Data:

   • Provide both clinical and non-clinical data proving the device’s accuracy, safety, and reliability.
   • Include validation and verification data, covering analytical performance, sensitivity, specificity, and any relevant testing that confirms the device meets safety and performance requirements.

4. Labeling and Instructions for Use (IFU):

   • Prepare labels and IFU that meet MDA’s regulatory requirements, covering:
     • Device name and intended use.
     • Instructions for device operation and interpretation of results.
     • Warnings, precautions, contraindications, and any other relevant information.
   • Labels should be in English and, if required, in a local language.

5. Quality Management System (QMS) Documentation:

   • Include an ISO 13485 certificate as evidence of compliance with the standard. If the device is manufactured in multiple sites, each site must meet the QMS requirements.
   • If available, attach an audit report or relevant compliance documents to further demonstrate the QMS in place.

6. Declaration of Conformity:

   • A formal declaration signed by the manufacturer affirming that the device conforms to Malaysian regulatory requirements.
   • This document should reference specific standards or regulations to which the device complies.

7. Manufacturer Information:

   • Provide details of the manufacturer, including the company name, address, and contact information.
   • If manufacturing or assembly is outsourced, provide information on subcontractors and evidence of their compliance with quality and safety standards.

8. Local Authorized Representative (if applicable):

   • For foreign manufacturers, include documentation of the Malaysian-based authorized representative. This representative must be registered with MDA and act on behalf of the manufacturer for regulatory affairs and post-market activities.

Preparing the Application Documents

1. Organize Documents Logically:

   • Divide your application into sections, grouping similar documents together (e.g., technical specifications, risk management documents, performance data).
   • Include a table of contents to improve navigation and facilitate MDA’s review.

2. Format for Electronic Submission:

   • The Medical Device Information and Safety System (MeDISS) portal requires digital uploads, so prepare all documents in PDF format, making sure they are clear, readable, and accessible.

3. Ensure Consistency Across Documents:

   • Ensure that details in the device description, labeling, and IFU are consistent and align with the device’s intended use and safety profile.

4. Follow MDA Guidelines on Language:

   • All documents should be in English, and any labeling may need to be translated into Bahasa Malaysia if required for specific devices or if the device targets the general public.

5. Verify Document Completeness:

   • Perform a final check to ensure that each document is complete, with all sections and signatures where necessary, such as on the Declaration of Conformity.

6. Pre-Submission Quality Check:

   • A regulatory consultant or a local representative familiar with MDA requirements can perform a pre-submission review of the documents to ensure completeness and compliance.

By thoroughly preparing these materials and ensuring document accuracy, you’ll improve the efficiency of the registration process and reduce the likelihood of additional requests from MDA, which can delay approval.

Contact Us：

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