Post Market Surveillance of Medical Devices in Cambodia The Department of Drug and Food requires foreign manufacturers to undertake post-market surveillance (PMS) following the ASEAN Medical Device Directive (AMDD) which came into effect on 1st January 2015. Please read further to understand how post-market surveillance is implemented in Cambodia. Contact Us Home What are the […]
Post Market Surveillance of Medical Devices in Vietnam The Department of Medical Equipment and Construction (DMEC) of the Ministry of Health (MoH), requires foreign manufacturers to undertake post-market surveillance (PMS) in accordance with the ASEAN Medical Device Directive (AMDD) which came into effect on 1st January 2015. However, each ASEAN member state is free in
Post-Market Surveillance of Medical Devices in the Philippines The Philippines’ Food and Drug Administration (PFDA) is the local authority responsible for medical devices in the Philippines and requires all medical device manufacturers and distributors (whether importer, exporter or wholesaler) to undertake post-market surveillance (PMS) and have a PMS plan. The Philippines FDA has chosen to
Post Market Surveillance of Medical Devices in Thailand The Thai Food and Drug Administration (Thai FDA) as a department of the Ministry of Public Health requires the Establishment License Holder, the Product License Holder or the Specification Provider to report medical device problems including device defects or Adverse Effect (commonly known as Adverse Events AE)
Post Market Surveillance of Medical Devices in Singapore The Health Science Authority (HSA) in Singapore requires product owners to implement a Post Market Surveillance (PMS) plan in place in accordance with the ASEAN Medical Device Directive (AMDD) which came into effect on 1st January 2015. However, each ASEAN member state is free in implementing the
Post Market Surveillance of Medical Devices in Malaysia The Medical Devices (Duties and Obligations of Establishment) Regulations 2019 detail the requirements for post market surveillance and vigilance for all medical devices in Malaysia as legislated for in Chapter 3 of the Medical Devices Act 2012 (Act 737). These regulations are imposed to ensure manufacturers, importers,
Post Market Surveillance of Medical Devices in Indonesia Post market surveillance of medical devices in Indonesia is under the control of the Surveillance Directorate of Medical Device and Household Health Supplies (PKRT) in the Ministry of Health (MoH). Manufacturers and their local authorized representative or importer are required to implement post market surveillance (PMS) in
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ANDAMAN MEDICAL PTE LTD (Head Office Singapore)
Tampines Junction Business Center
Level 09-02, 300 Tampines Avenue 5,
Singapore 529653
