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.
What are the requirements for medical device PMS in Cambodia?
Following Annex 5 of the AMDD, the following is required as part of the post-market surveillance (PMS) in Cambodia:
Importation and/or Distribution records
Traceability is not only a requirement of an effective quality system but also the requirement of regulatory bodies around the world. Keeping proper and appropriate importation and/or distribution records is an important component of ensuring the traceability of medical devices in the market.
An effective complaint handling system is an important part of any quality system. Any complaint received on a medical device should be evaluated and if necessary, thoroughly investigated and analyzed, and corrective actions should be taken. The results of the evaluation should lead to a conclusion regarding whether the complaint was valid, the causes of the complaint, and what actions were necessary to prevent further occurrences.
Several post-marketing risk assessment measures to ensure the continued safe use of medical devices may be undertaken. These measures include reporting from healthcare professionals, mandatory reporting from medical device dealers, and the exchange of regulatory information with other medical device regulatory agencies. The mandatory reporting of AEs by medical device dealers is an important part of the post-market surveillance system. The objective of AE reporting and subsequent evaluations is to improve the protection of the health and safety of patients, users, and others by disseminating information that may reduce the likelihood of, or prevent the repetition of AEs, or alleviate the consequences of such repetition.
Field Safety Corrective Action (FSCA)
An FSCA is required when it becomes necessary for the product owner of the medical device to take action (including recall of the medical device) to eliminate or reduce the risk of, the hazards identified. An FSCA may still be necessary even when the medical device is no longer on the market or has been withdrawn but could still possibly be in use (e.g. implants). An FSCA only applies to a medical device that has already been distributed by the product owner. It does not arise when a product owner is exchanging or upgrading medical devices in the absence of a safety risk or when removals from the market are for purely commercial reasons.
Adverse Event Reporting Timeline
All adverse events (AEs) should be reported immediately and;
How Andaman Medical can help you with post market surveillance in Cambodia
With 8 local offices throughout Southeast Asia, Andaman Medical provides support for your post-market surveillance activities including adverse events and FSCA mandatory reporting. Our local, in-house staff liaise with the Food and Drug Administration to help you maintain compliance once your medical device is placed on the market. Our services include: