In August 2014, the Association of Southeast Asian Nations (ASEAN) signed a formal agreement that harmonized medical device regulations. This agreement, formally called the ASEAN Medical Device Directive (AMDD), provides a more straightforward path to the market for medical device manufacturers.
ASEAN Common Submission Dossier Template (CSDT)
An important element of the AMDD is the ASEAN common submission dossier template (CSDT). The CSDT is a collection of information and requirements that allows a device manufacturer to provide different regulatory authorities with the same body of documentary evidence. Use of the CSDT helps to reduce costs for manufacturing companies seeking to obtain device approval in any of the 10 ASEAN countries.
Indonesia Medical Device Regulations
The National Agency of Drug and Food Control is responsible for medical devices in Indonesia. While Indonesia has no overarching medical device regulation, 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 in Indonesia, please see Medical Device Registration in Indonesia.
Malaysia Medical Device Regulations
The Medical Device Agency is the specific organization tasked with overseeing Malaysia medical device regulations. There are two separate acts that govern the manufacturing and distribution of medical devices in Malaysia. These acts are the Medical Devices Act and the Medical Device Authority Act. These two acts were formally approved in 2012.
For more detailed information about the regulatory requirements and registration process for medical devices in Malaysia, please see Medical Device Registration in Malaysia.
Philippines Medical Device Regulations
Working as a department under the supervision of the Department of Health, the Philippines Food and Drug Administration is tasked with monitoring and regulating medical devices. The Center for Device Regulation, Radiation Health, and Research also has a role in overseeing medical devices.
For more detailed information about the proposed guidelines for device registration for medical devices in Philippines, please see Medical Device Registration in the Philippines.
Thailand Medical Device Regulations
Thailand’s Food and Drug Administration is the chief regulatory agency. The Medical Device Control Division is the specific branch dedicated to device regulations. The Medical Device Acts are the set of regulations that govern the manufacturing and distribution of medical devices within Thailand. The most recent version of the Medical Device Act was passed in 2008.
For more detailed information about the registration application and approval pathway for medical devices in Thailand, please see Medical Device Registration in Thailand.
Vietnam Medical Device Regulations
Vietnam’s Ministry of Health institutes the rules and regulations that govern medical devices. 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. Certain 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 in Vietnam, please see Medical Device Registration in Vietnam.
ASEAN Medical Device Regulatory Resources
ASEAN Medical Device Regulatory News
Pacific Bridge Medical releases timely news briefs on medical device regulatory affairs in Asia every month. Click here to view the latest updates on medical device regulations from the ASEAN countries.
ASEAN Medical Device Publications & Presentations
- Asia Medical Device Markets Overview Presentation
- 2014 ASEAN Medical Device Update
- Medical Device Harmonization in Southeast Asia
- The Philippines Medical Device Market 2013
- Vietnam’s Medical Device Market 2013
- Thailand Medical Device Update 2013
- Malaysia Medical Device Market Update
- Vietnam Medical Device Market Updates Webcast