Medical Regulatory Agencies in Asia

The United States has the Food and Drug Administration (FDA). What is the equivalent agency in China? India? The Philippines? Below you will find a list of the medical regulatory agencies in Asia and the acronyms associated with them along with some insights into working within the regulatory agencies in these specific countries.

China SFDA

The State Food and Drug Administration (SFDA) is akin to the FDA of the United States. This regulatory entity regulates drugs, medical devices, health foods and cosmetics. There are ten departments under the SFDA. The three departments that are of relevance to medical devices and drugs are the Department of Medical Devices, the Department of Drug Regulation and the Department of Drug Safety and Inspection. There is a decentralization of authority within the SFDA that allows provincial SFDAs to operate relatively independently of the national SFDA.

Depending on the product being exported to China, a company may need to additionally register with the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ).

Hong Kong MDCO & PSDH

Although Hong Kong is a part of China, its status as a special administrative region allows for a significant amount of autonomy. In terms of medical device regulations, Hong Kong has its own set of unique medical device regulations that are different from those of China. In 2004, Hong Kong created the Medical Device Control Office (MDCO) as a part of the Department of Health to govern issues related to medical devices.

The Pharmaceutical Service (PSDH) is the agency that oversees medicines. The responsibilities of the PSDH include assessing applications for drug registration; inspecting and licensing manufacturers, wholesalers and retailers; and processing the import/export licenses of pharmaceutical products.

India CDSCO

The Central Drug Standards Control Organization (CDSCO) regulates drugs, cosmetics, diagnostics and devices in India. The CDSCO is headed by the Drug Controller General of India (DCGI). The CDSCO is responsible for the safety, efficacy, and quality standards for pharmaceuticals and medical devices, and publishes the Indian Pharmacopoeia. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Commission (DCC). All licenses for medical devices are handled by the Central Licensing Approval Authority (CLAA).

State governments are responsible for licensing, approvals, inspection and recalls of drugs manufactured within their domain.

Japan MHLW

The main regulatory body for creating laws and standards for medical devices and drugs in Japan is the Ministry of Health, Labour and Welfare (MHLW). Under the MHLW is the Pharmaceutical and Food Safety Bureau. This bureau is in charge of setting pharmaceutical and medical device regulatory policy.

The Pharmaceuticals and Medical Devices Agency (PMDA) is another Japanese regulatory agency that works alongside the MHLW to ensure the safety, efficacy and quality of pharmaceuticals and medical devices. They review marketing authorization applications for pharmaceuticals and medical devices, and monitor post-marketing safety.

Korea KFDA

The Korean Food and Drug Administration (KFDA) resembles the FDA of the United States. It was established in 1998 and regulates foods, pharmaceuticals, medical devices and cosmetics The KFDA is divided into five bureaus, including the Pharmaceutical Safety Bureau and the Medical Device Safety Bureau. These bureaus hold primary responsibility for pharmaceutical and medical device regulations. In addition to its main office in Seoul, the KFDA also has six regional offices that serve as field operational bases.

Malaysia MOH

Under Malaysia’s Ministry of Health (MOH) are the Medical Device Bureau (MDB) and the National Pharmaceutical Control Bureau (NPCB). The MDB ensures the quality, safety and efficacy of medical devices in Malaysia, while the NPCB does the same for pharmaceuticals. Both bodies are also responsible for setting laws and standards, registering health products and issuing licenses to manufacturers, distributors, importers and exporters.

Philippines DOH

The Department of Health (DOH) is the main health agency in the Philippines. The DOH oversees access and quality of public health services and regulates providers of health goods and services. In addition to the DOH, the Philippine Food and Drug Administration (FDA) was established in 2009 to replace the Bureau of Food and Drugs (BFAD). The FDA has the power to immediately recall, ban, or withdraw medical products that fail safety standards or are found to pose a threat to the public. In addition, the agency will be authorized to inspect facilities for compliance and seize products that have safety issues.

Singapore HSA

The Health Sciences Authority (HSA) was established in 2001 to regulate health products and oversee public health issues in Singapore. Under the HSA is the Health Products Regulation Group (HPRG), which is a body that ensures that drugs, medical devices and other health products are regulated to meet quality, safety and efficacy standards.

Taiwan TFDA

Taiwan’s Department of Health (DOH) was the main health agency in Taiwan until the consolidation of the Bureau of Food Safety, the Bureau of Pharmaceutical Affairs, the Bureau of Food and Drug Analysis and the Bureau of Controlled Drugs in January, 2010. This marked the establishment of the Taiwan Food and Drug Administration (TFDA). The TFDA is now the body which ensures drugs, medical devices and other health products are regulated to meet quality, safety and efficacy standards. It works alongside the DOH, whose responsibilities are now relegated to overseeing access and quality of public health services.

Thailand FDA

The Food and Drug Administration of Thailand (FDA Thailand) is the organization responsible for the safety, quality and efficacy of pharmaceuticals and medical devices in Thailand. This organization is split into two divisions, the Support Division and the Health Product Control Division. The Bureau of Drug Control (BDC) and the Bureau of Medical Device Control (BMDC) operate under the latter. These are each responsible for the development and review processes of products within their remit. Regulatory policy and enforcement are handled by committees under the FDA.

Vietnam MOH

Under Vietnam's Ministry of Health (MOH), the Drug Administration of Vietnam (DAV) is responsible for the regulation of pharmaceuticals, and the Department of Medical Equipment and Health Works (DMEHW) is responsible for the regulation of medical devices. The DAV evaluates pharmaceutical applications for their compliance with the 2005 Pharmaceutical Law and issues licenses accordingly. The DMEHW handles product registration and evaluation for medical devices.