Regulation of Surface Disinfectants in Malaysia

With the outbreak of the global pandemic, Malaysia continues to fight the war against COVID-19. This period has been overwhelming for both the Malaysian Pharmaceutical industry as well as the consumers. As public and personal hygiene became the first defense against the virus, change in consumer behavior has been observed, especially regarding hygiene-related products in the Malaysian market. Surface disinfectants, being one among such hygiene products, have experienced a significant surge in demand.

The fact that the disinfection practices reduce the potential for bacterial or viral contamination and are essential in both clinical and non-clinical settings has encouraged the Ministry of Health (MoH), Malaysia, to regulate these products.

Recently, the MoH announced the National Pharmaceutical Regulatory Authority (NPRA) as the official authorized Regulatory Agency to regulate surface disinfectants in Malaysia. As surface disinfectants are not formally regulated in Malaysia, the NPRA has developed a guideline document with numerous collaborative engagements with industry experts.

Under the current guidelines, sanitization or disinfection products are categorized under the following three (03) categories:

  • Category 1: Used for sanitization or disinfection of skin/human and animal body parts
  • Category 2: Used for sanitization or disinfection of medical devices
  • Category 3: Used for sanitization or disinfection of all types of surfaces (except on human, animal and medical devices)

These guidelines serve as a reference for Malaysia’s production, importation, sale and use of surface disinfectants. They are further intended to:

  • Guide manufacturers to use ingredients that are safe and effective
  • Enable manufacturers to select appropriate standards to support their claims
  • Enable proper use of the product as directed
  • Assist the Regulatory authority in assessing the labeled claims

The surface disinfectant registration is voluntary and any applicant who wishes to register a surface disinfectant must manually submit the product information and related documents to the NPRA for evaluation. The submission is by appointment only. Currently, the registration validity period is twelve (12) months and there is no registration fee.

This regulation will ensure a flow of quality surface disinfectants in Malaysia. The disinfectant manufacturers will benefit from the association with a Health Authority and the consumers will have the HA verified, safe and effective products at their use. The guidelines are subjected to continuous review by the NPRA therefore it is advised to stay updated with the Health Authority information and requirements continuously. To avoid pitfalls during the registration process, Reach out to a Regulatory expert.