ASEAN Medical Device and Pharmaceutical Regulations

The Association of Southeast Asian Nations (ASEAN), which is comprised of the countries Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam, Brunei, Laos, Myanmar, and Cambodia, was established in 1967 to promote peace and stability in the region, facilitate collaboration and mutual assistance among the member states, and accelerate regional economic growth, social progress, and cultural development. To these ends, the member nations are working to create harmonized standards in order to remove technical barriers to trade and support the establishment of an integrated market. Healthcare is one of the primary sectors identified for economic integration.

ASEAN Common Submission Dossier Template (CSDT) for Medical Devices

In 2015, the Association of Southeast Asian Nations (ASEAN) signed an agreement, formally called the ASEAN Medical Device Directive (AMDD), that aimed to harmonize medical device regulations. The AMDD provides a more straightforward path to the market for medical device manufacturers. An important element of the AMDD is the ASEAN Common Submission Dossier Template (CSDT), a collection of information and requirements that allows a device manufacturer to provide the same body of product registration documentation to the different regulatory authorities of the ASEAN member states. Use of the CSDT helps to reduce costs for manufacturing companies seeking to obtain device approval in any of the ten ASEAN countries.

The AMDD classifies medical devices into four classes based on risk level. Class A products are low risk, Class B products are low-moderate risk, Class C products are moderate-high risk, and Class D products are high risk.

ASEAN Common Technical Dossier (ACTD) for Pharmaceuticals

The ASEAN Common Technical Dossier (ACTD) was created with the aim to serve as a harmonized guideline for pharmaceutical product registrations in the ASEAN countries. The use of a common format is intended to simplify the registration process and reduce the time and resources needed to put together registration applications.

The ACTD includes four main sections that cover required registration application documents and product information, quality control documents, nonclinical documents, and clinical documents. The dossier also identifies the following categories of drugs: New Chemical Entities (NCE), Biotechnological Products (Biotech), Major Variations Products (MaV), Minor Variations Products (MiV), and Generics (G).

For more information about Singapore’s regulatory framework, please see Singapore Medical Device and Pharmaceutical Regulations. For Malaysia, the Philippines, Thailand, Indonesia, and Vietnam, please view details below.

Malaysia Medical Device and Pharmaceutical Regulations

Malaysia’s Ministry of Health governs healthcare affairs in the country. Under the Ministry of Health, the Medical Device Authority is the government organization tasked with overseeing Malaysia medical device regulations. The legislations that regulate the manufacturing and distribution of medical devices in Malaysia are the Medical Devices Act, the Medical Device Authority Act, and the Medical Device Regulations, all released in 2012.

Also under the Ministry of Health, the National Pharmaceutical Regulatory Agency (NPRA) is responsible for conducting quality control on pharmaceuticals and ensuring the quality, efficacy, and safety of pharmaceutical products through the registration and licensing system. Within the agency, the Drug Control Authority (DCA) is the executive body that controls drug registrations; importer, manufacturer, and wholesaler licenses; quality monitoring of registered products; and adverse drug reaction monitoring. Pharmaceuticals are regulated under the Control of Drugs and Cosmetics Regulations, the Sale of Drugs Act, and the Drug Registration Guidance Document (DRGD).

For more detailed information about the regulatory requirements and registration process for medical devices and pharmaceuticals in Malaysia, please see Medical Device Registration in Malaysia and Pharmaceutical and API Product Registration in Asia.

The Philippines Medical Device and Pharmaceutical Regulations

Working as a department under the supervision of the Department of Health, the Philippines Food and Drug Administration (FDA) is tasked with monitoring and regulating pharmaceuticals and medical devices. Within the FDA, the Center for Drug Regulation and Research (CDRR) and the Center for Device Regulation, Radiation Health, and Research (CDRRHR) oversees pharmaceuticals and medical devices respectively.

For more detailed information about the proposed guidelines for device registration for medical devices and pharmaceuticals in Philippines, please see Medical Device Registration in the Philippines and Pharmaceutical and API Product Registration in Asia.

Thailand Medical Device and Pharmaceutical Regulations

Thailand’s Food and Drug Administration (FDA) is the chief regulatory agency for health products in the country. The FDA is responsible for pre-market controls, post-market controls, and adverse effects surveillance. The Bureau of Drug Control regulates pharmaceuticals in accordance with the Drug Act, while the Medical Device Control Division regulates medical devices in accordance with the Medical Device Act.

For more detailed information about the registration application and approval pathway for medical devices and pharmaceuticals in Thailand, please see Medical Device Registration in Thailand and Pharmaceutical and API Product Registration in Asia.

Indonesia Medical Device and Pharmaceutical Regulations

The National Agency of Drug and Food Control (NA-DFC) is responsible for the supervision of drugs and medical devices in Indonesia. While Indonesia has no specific regulations for medical devices, it has implemented global quality norms such as ISO 13485 in an attempt to harmonize its regulations with existing international law.

For more detailed information about the registration steps and timeline for medical devices and pharmaceuticals in Indonesia, please see Medical Device Registration in Indonesia and Pharmaceutical and API Product Registration in Asia.

Vietnam Medical Device and Pharmaceutical Regulations

Vietnam’s Ministry of Health institutes the rules and regulations that govern medical devices and drugs. The Department of Medical Equipment and Health Works is the subsection of the Ministry of Health responsible for overseeing medical device registration and approval in Vietnam, while the The Agency of Drug Administration controls pharmaceuticals. Certain medical devices with new technologies may also be asked to submit information to the Ministry of Science and Technology.

For more detailed information about the regulatory pathway and application requirements for medical devices pharmaceuticals in Vietnam, please see Medical Device Registration in Vietnam and Pharmaceutical and API Product Registration in Asia.

ASEAN Medical Device and Pharmaceutical Regulatory Resources

For more free information and resources on the Asian medical device and pharmaceutical regulations and healthcare markets, please check out our Resource Center and Blog.