Medical Devices Post-Market Surveillance in Singapore
Why Get Medical Devices PMS in Singapore
Regulatory Compliance
Regulatory Compliance
Post-market surveillance (PMS) is a mandatory requirement by the Ministry of Health to ensure continued safety, effectiveness, and quality of medical devices in the market. Regular monitoring helps maintain compliance with local regulations and avoids penalties.
Early Detection of Issues
Early Detection of Issues
PMS allows for the early identification of potential safety concerns, performance issues, or adverse events related to your device. This proactive approach helps prevent widespread problems and protects patients from harm.
Improvement of Product Quality
Improvement of Product Quality
Continuous monitoring provides valuable feedback on device performance in real-world settings. This information can be used to enhance product design, manufacturing processes, and overall quality, leading to better patient outcomes.
Maintaining Market Authorization
Maintaining Market Authorization
Effective post-market surveillance is critical for maintaining your device’s market authorization. Ongoing compliance with surveillance requirements demonstrates your commitment to product safety and helps avoid the risk of losing regulatory approval.
Building Trust with Healthcare Providers
Building Trust with Healthcare Providers
PMS data helps build confidence among healthcare professionals by providing evidence of ongoing device performance and safety. This trust can lead to increased adoption and recommendation of your products.
Risk Management and Mitigation
Risk Management and Mitigation
PMS helps manufacturers identify and address risks associated with their devices, enabling timely corrective actions and reducing the likelihood of costly recalls, legal issues, and damage to brand reputation.
Our Medical Device Post Market Surveillance Services
Report Management
Support for your mandatory reporting of Adverse Effects and Field Safety Corrective Actions
Documentation
Identify requirements in medical device directives, standards, and guidance documents
Data Evaluation
Evaluate your PMS data to ensure that existing processes and outputs are fully compliant
Maintain Compliance
Monitor and report on any regulatory changes to ensure ongoing compliance
Medical Device PMS Requirements in Singapore?
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 Singapore 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 for medical devices 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 uses a number of post-market surveillance of medical devices and 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.
The HSA requires that data generated by Singapore’s PMS for medical device 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)
- persons affected by the incident (only for AE)
- Complaints
- Databases and/or registries
- Feedback
In addition to the requirement for manufacturers to implement a PMS for medical devices in Singapore, there are specific requirements for adverse events and FSCAs applicable to all economic operators (manufacturers, importers, distributors, local authorised representatives).
Medical Device PMS Requirements in Singapore?
- 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.
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 Singapore 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 for medical devices 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 Singapore’s PMS for medical device 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).
- Serious incidents
- Field Safety Corrective Actions (FSCAs)
- persons affected by the incident (only for AE)
- Complaints
- Databases and/or registries
- Feedback
Adverse Event (AE) reporting requirements in Singapore
| Adverse events | Report within |
|---|---|
| Serious threat to public health | 48 hours |
| Death | 10 days |
| Serious deterioration in state of health | 10 days |
| Possible death or serious injury if the adverse event were to recur | 30 days |
In accordance with Singapore’s post-market surveillance of medical devices, if there is uncertainty about whether the AE is reportable, you should submit a report within the specified time frames. The clock for reporting starts as soon as any personnel in your company, including sales representatives, are made aware of the AE.
FSCA Reporting Requirements
- Product recall
- Product replacement
- Product destruction
- Product modification including any retro-fitting
- Permanent or temporary changes to the labelling or IFU
- Software upgrades
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.
