Post Market Surveillance of Medical Devices
Medical device manufacturers and their locally appointed dealers (aka economic operators) are required to carry out Post-Market Surveillance (PMS) to ensure the quality and evaluate the safety, performance, and effectiveness of medical devices. This means manufacturers and appointed dealers shall actively monitor those medical devices placed on the market in order to protect users and the final consumer (patient) of the medical device.
Post Market Surveillance of Medical Devices in Singapore, Malaysia, Indonesia, the Philippines, Thailand, Cambodia and Vietnam
Singapore, Malaysia, Indonesia, the Philippines, Thailand, Cambodia and Vietnam are all signatories to the ASEAN Medical Device Directive (AMDD) which was created to harmonize medical device legislation throughout Southeast Asia. Article 12 of the AMDD calls for member states (10 countries in total) to take all necessary steps to appropriately record and evaluate information regarding incidents involving a medical device placed on the market in their respective country, such as malfunction, deterioration, or inadequacy which may lead to or may have led to the death or serious deterioration of the health of a patient or user.
To do this member countries are required to set up a PMAS (Post Marketing Alert System) which should cover at least:
- Importation and/or distribution records
- Complaint records
- Adverse Events (AE) reporting criteria and reporting format
- Field Safety Corrective Action (FCSA) reporting format.
However, each ASEAN member is at liberty to legislate for a PMAS to suit their local requirements. To find out more about PMS requirements for manufacturers and locally appointed dealers in Singapore, Malaysia, Indonesia, the Philippines, Thailand and Vietnam click on the relevant country page below.
As such at this point in time (end of 2020), PMS requirements in the AMDD are predominantly reactive reporting as opposed to proactive customer surveys and Post Market Clinical Follow-up (PMCF) studies. Nevertheless, as part of good business practice as well as regulatory compliance elsewhere in the world, all manufacturers and their dealers shall develop, implement and maintain systematic procedures to proactively collect and review data gained from medical devices placed on the market in order to identify needs for Corrective and Preventive Actions (CAPA).
How Andaman Medical can help you with your post market surveillance:
With six local offices throughout Southeast Asia, Andaman Medical provides support for your post-market surveillance activities including adverse event and FSCA mandatory reporting. Our local, in-house staff liaise with the local medical device authorities to help you maintain compliance once your medical device is placed on the market. Our services include:
- Support for your mandatory reporting of Adverse Events and Field Safety Corrective Actions
- Identify requirements in medical device directives, standards, and guidance documents to ensure effective implementation of a post-market surveillance system
- Evaluate your PMS data to ensure that existing processes and outputs are fully compliant
- Monitor and report on any regulatory changes to ensure ongoing compliance