When registering a Class A medical device with the Medical Device Authority (MDA) in Malaysia, several technical documents are required to ensure compliance with the Medical Device Act 2012 and the Medical Device Regulations 2012. These documents verify the device's safety, performance, and regulatory compliance.

Technical Document Requirements for Class A Medical Device Registration

1. Device Description and Classification

• Device Name and Model Number: Provide the official name and model number of the medical device.
• Device Classification: Include the classification of the device, confirming that it is Class A (low risk).
• Intended Use: Describe the device’s intended medical purpose, its function, and the target user.
• Risk Classification and Justification: For Class A devices, the classification typically doesn’t require extensive documentation, but a brief explanation of the device’s low-risk nature may be necessary.

2. Certificate of Free Sale (CFS)

• For Foreign Manufacturers: If the manufacturer is located outside Malaysia, a Certificate of Free Sale (CFS) is required. The CFS must be issued by the relevant regulatory authority of the country where the device is manufactured, confirming that the device is legally marketed in that country.
• For Local Manufacturers: The CFS is not necessary, but proof of local market approval may be required.

3. Declaration of Conformity

• A Declaration of Conformity from the manufacturer must be submitted, stating that the medical device complies with the relevant regulatory and safety standards, including:
  • ISO 13485: Quality management system for medical devices.
  • ISO 14971: Risk management for medical devices.
  • IEC standards (if applicable, such as IEC 60601 for electrical medical devices).
• The Declaration must also confirm that the device complies with the Medical Device Act and the Medical Device Regulations of Malaysia.

4. Good Manufacturing Practice (GMP) or ISO 13485 Certification

• For Foreign Manufacturers: You must provide evidence of the manufacturer’s compliance with Good Manufacturing Practices (GMP) or ISO 13485 (Quality Management System for Medical Devices). This can include a copy of the ISO 13485 certification or equivalent regulatory approval that demonstrates adherence to international standards for medical device manufacturing.
• For Local Manufacturers: Proof of compliance with local GMP standards or an ISO 13485 certification may be required if applicable.

5. Product Labeling

• Labeling Requirements: The device must have appropriate labeling that complies with MDA regulations. This includes:
  • The device name.
  • Manufacturer’s name and address.
  • Intended use or purpose of the device.
  • Instructions for use (IFU).
  • Any warnings, contraindications, or precautions.
  • Batch or serial number (if applicable).
  • Languages: The labels and instructions for use should be in Bahasa Malaysia and/or English.
• Symbols: If the labeling includes symbols, ensure compliance with ISO 15223-1 for medical device symbols.

6. Risk Management Report

• A Risk Management Report based on ISO 14971 (Risk Management for Medical Devices) may be required, although it’s usually less detailed for Class A devices compared to higher-risk devices.
• The risk management documentation should demonstrate that any potential risks associated with the device have been identified, evaluated, and mitigated.

7. Clinical Evidence (if applicable)

• Clinical Evidence: For most Class A devices, clinical evidence is generally not required. However, if the device has any claims related to clinical benefits or is subject to specific regulatory requirements, clinical data or studies may need to be provided.
• Post-Market Surveillance: A plan for post-market surveillance may be requested to ensure that any unforeseen issues related to the device’s performance are tracked after it reaches the market.

8. Instructions for Use (IFU)

• IFU Document: The Instructions for Use should be clear, detailed, and follow the MDA's guidelines. This includes proper directions on how to use the device, maintenance instructions, and safety precautions.
• For devices that are not sterile, special considerations on cleaning, storage, and handling may be necessary in the IFU.

9. Local Authorized Representative (LAR) Appointment Letter (For Foreign Manufacturers)

• If the manufacturer is located outside Malaysia, you must appoint a Local Authorized Representative (LAR) in Malaysia. An official appointment letter from the manufacturer designating the LAR to act on their behalf during the registration process is required.

10. Product Testing and Performance Data (if applicable)

• While Class A devices generally do not require extensive testing data, any relevant performance data or test reports may be necessary to demonstrate that the device complies with applicable safety standards.
• This may include biocompatibility testing for devices that come into contact with the skin or body.

Summary of Key Documents for Class A Medical Device Registration:

1. Device Description and Classification.
2. Certificate of Free Sale (CFS) (for foreign manufacturers).
3. Declaration of Conformity (compliance with relevant standards).
4. Good Manufacturing Practice (GMP) or ISO 13485 Certification.
5. Product Labeling (compliance with MDA requirements).
6. Risk Management Report (usually based on ISO 14971).
7. Clinical Evidence (if applicable).
8. Instructions for Use (IFU).
9. Local Authorized Representative Appointment Letter (for foreign manufacturers).
10. Performance Testing and Data (if applicable).

Preparation Tips:

• Ensure accuracy: Verify that all documents are correctly filled out and meet the MDA's specifications.
• Document formatting: All documents must be in the correct format (usually PDF) and legible.
• Consistency: Ensure that all references in the product description, labeling, and Declaration of Conformity are consistent.
• Language: If required, translate documents like the IFU into Bahasa Malaysia or provide dual language versions.

By preparing and submitting these technical documents, you will be able to meet the MDA’s regulatory requirements for Class A medical device registration in Malaysia.

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