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 PMS requirements and each country has its own specificities, please read on to understand how this is implemented in Singapore.
What are the requirements for medical device PMS in Singapore?
The HSA uses a number of post marketing risk assessment measures to ensure the safety of medical devices. These measures include:
- mandatory reporting by medical device dealers (economic operators such as manufacturers and distributors)
- reporting from healthcare professionals
- and an information exchange with medical device regulatory agencies in other ASEAN member states.
Mandatory Reporting of Adverse Events (AE) by dealers is a central part of post market surveillance in Singapore (please see below link to section on AEs).
Every manufacturer, importer, supplier, or registrant of a medical device must maintain a record of every received complaint and produce that record for inspection by HSA. The record must contain detailed information as per the Health Products Act (Medical Devices) Regulations, 41. They are required to plan, establish, document, implement, maintain, and update a PMS system for medical devices placed on the market. The system must be designed and documented in a PMS plan and then constantly updated according to a structured assessment of how well it is working and the data it has yielded. Post market surveillance is required for all events occurring in Singapore in accordance with the Health Products Act and the Health Products (Medical Devices) Regulation 2010.
The HSA requires that data generated by the PMS system is used in specific ways; in particular it should be used to:
- update the device’s benefit-risk analysis
- feed improvements to risk management
- update the device’s design, Instructions For Use (IFU) and labels
- update the device’s clinical evaluation
- to identify needs for Corrective And Preventive Actions (CAPA) or Field Safety Corrective Actions (FSCA).
The PMS plan should collect data from a range of different sources including:
- Serious incidents
- Field Safety Corrective Actions (FSCAs)
- Databases and/or registries
In addition to the requirement for manufacturers to implement a PMS, there are specific requirements for adverse events and FSCAs applicable to all economic operators (manufacturers, importers, distributors, local authorised representatives).
Adverse Event (AE) reporting requirements in Singapore
The following medical device associated AEs must be reported to the HSA:
|Serious threat to public health
|Serious deterioration in state of health
|Possible death or serious injury if the adverse event were to recur
All companies dealing in medical devices including manufacturers, importers, suppliers, and registrants are required to report adverse events of their products. The Mandatory Medical Device Adverse Event Reporting Form for Medical Device Dealers must be filled in and submitted to the HSA. If more than one dealer is involved in a reportable AE, each dealer must submit their own report.
If there is uncertainty about whether the AE is reportable, you should submit a report within the above time frames as the clock for reporting starts as soon as any personnel in your company, including sales representatives, are made aware of the AE.
Field Safety Corrective Action reporting requirements in Singapore
An FSCA is any action taken concerning the medical device to reduce the risk of death or the serious deterioration of the health of a user or patient. Possible FSCAs include:
- Product recall
- Product replacement
- Product destruction
- Product modification including any retro-fitting
- Permanent or temporary changes to the labelling or IFU
- Software upgrades
You must report an FSCA if the medical device has been manufactured, imported or supplied in Singapore OR the medical device has been registered or has been given special authorisation for local supply (even if it is not currently placed on the market).
The reporting person should be the dealer that manufactured, imported, supplied or the product registrant for the device concerned. In cases where more than one dealer is involved, each dealer will need to report the FSCA individually.
Before initiating the FSCA, the dealer must notify the HSA. Once it’s been reported, the dealer can proceed without waiting for approval from the HSA.
Medical device dealers must report the Field Safety Corrective Action via the newly launched Online Safety, Compliance Application and Registration (OSCAR) System.
How Andaman Medical can help you with post market surveillance in Singapore
With 6 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 HSA to help you maintain compliance once your medical device is placed on the market. Our services include: