Malaysia's Ministry of Health (MOH)

National Pharmaceutical Control Bureau (NPCB) and Medical Devices Bureau (MDB)

The National Pharmaceutical Control Bureau (NPCB) and Medical Devices Bureau (MDB) are the bureaus under the Malaysian Ministry of Health (MOH) responsible for ensuring the quality, efficacy, and safety of pharmaceuticals and medical devices.

Founded in 1978, the NPCB sets and enforces Malaysia's regulatory policy for pharmaceuticals. Since 1985 the NPCB has been responsible for drug registration and issuing licenses for pharmaceuticals to manufacturers, distributors, importers and exporters. For pharmaceuticals on the market, the NPCB conducts random sampling, monitors adverse events, and issues recalls when necessary. The NPCB also trains pharmacists, collects and disseminates information about pharmaceuticals, and helps manufacturers upgrade their facilities to meet World Health Organization (WHO) Good Manufacturing Practice (GMP) standards.

Established in 2005, the MDB’s core competencies include registering medical devices and issuing licenses to manufacturers, distributors, importers and exporters. It also inspects facilities, monitors devices already on the market, including operation, usage and disposal of the aforesaid. The MDB also drafts regulations for medical devices and performs conformity assessment procedures to ensure compliance with those regulations. Furthermore, the MDB promotes the free trade liberalization of medical devices by working to establish Mutual Recognition Agreements (MRAs) with other countries on medical device regulations.

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