Malaysia: Requirements for Placement of Covid-19 RTK (Self-Test) in the Market

In November 2021, the MDA decided to offer conditional approval to clients seeking to sell Covid-19 self-test kits to better deal with the current pandemic situation. They also released guidance document MDA/GD/0059 to guide clients with the requirements for placing Covid-19 RTK (self-test) in the market. Note that conditional approval for Covid-19 RTK (self-test) is available in MDA/GL/05), and that MDA/GD/0059 does not apply for test kits for professional use only.

Requirements for establishment

• Shall have a valid MDA establishment license with in-vitro diagnostic (IVD) scope on the Good Distribution Practice of Medical Device (GDPMD) certification.

• Shall obtain a Conditional Approval Letter from MDA before placing the self-test kits into the market. Guidelines for applying for conditional approval can be found in MDA/GL/05.

• Shall comply with labelling requirements as specified in Sixth Schedule of the Medical Devices Regulations 2012. In labelling also include information for users on methods of reporting test results to medical practitioners/authorities and clear disposal methods. (Labeling should be in Bahasa Malaysia).

• Labelling shall also contain a QR code that links to the instructions for use, disposal method and reporting mechanism, and purchase information.

• Shall prepare video tutorials and infographics to help users better understand safe use, disposal methods and result reporting

• Shall collect and report safety and performance data to be reported to MDA on a regular basis, or as and when required. The template of the data collection on safety and performance can be found in Annex A of MDA/GD/0059.

• Ensure precautions and control are in place to prevent damage and deterioration before device is in use

• Ensure delivery of the test kits adhere to conditions specified by manufacturer.

• Keep a record of all information pertaining to the self-test kits including, invoices, delivery order (DO), and summary of distribution, and ensure they are always available upon request.

Requirements for sale of Covid-19 RTK (self-test) The Covid-19 RTK (self-test) can only be sold by:

• Pharmacies licensed with Pharmaceutical Services Division, MOH.

• Clinics or hospitals licensed with Private Medical Practice Control Section, MOH (CKAPS).

• establishments to another licensed establishments (with IVD scope in GDPMD)

• establishment to individual user

• establishments to companies/government or private organisations/ educational institutions for the purpose of supplying for use by workers, personnel, or students.

• other premises registered with KPDNHEP

Note that sale of Covid-19 RTK (self-test) is strictly prohibited.

Requirements for online sale of Covid-19 Rapid Self-Test Kit

Online sale of Covid-19 Rapid Self-test Kit can only be carried out by 1 to 5 in the previous section. However, note that delivery has to be done by suitable logistics providers with assurance of safety and performance. The online sales platform also has to provide a way to record sales and distribution information to assist the MDA. Requirements for Storage and stock handling The company shall ensure proper trainings are provided and sellers of Covid-19 Rapid Self-Test kits comply with storage and handling requirements as stated below:

• Stored and handled in accordance with manufacturer’s instructions to ensure integrity of the test kits.

• Ensure proper storage environment to ensure deterioration and damage to test kits.

• Proper identification and disposal of tests kits deemed damaged based on manufacture’s requirements.

Requirements for disposal of Covid-19 Rapid Test-Kits The company shall ensure proper instructions for disposal of test kits are included in the labelling. Instructions should also be available in infographic or video format for ease of understanding.

Requirements for advertising of Covid-19 Rapid Test-Kits Covid-19 Rapid Test-Kits are not allowed to be advertised since they are considered as unregistered medical products. In addition, it is prohibited to place MDA’s logo on the test kits, its labelling or any other material related to the sale of the kits. However, the following are allowed:

• Materials that strictly containing only price, pictorial representation of product, brand/company name and/or logo that do not contain any product claims or descriptions.

• Materials only containing exact replica of the packaging (not size but shape and labelling) as approved by the MDA during conditional approval.

Requirements for post market responsibility Companies are required to establish and maintain a post market surveillance system to monitor traceability of the test kits throughout he supply chain, and ensure the safety and performance of the test kits in the market. For more information on post-market responsibility, please refer to:

MDA /GD/0011, Complaint Handling

• MDA /GD/0012, Distribution Record

• MDA /GD/0013, Field Corrective Action

• MDA /GD/0014, Mandatory Problem Reporting

• MDA /GD/0015, Medical Device Recall

Sources:

MDA/GD/0059: Guidance Document on Requirements for Covid-19 RTK (Self-test)

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