Medical Devices Post-Market Surveillance in Singapore

Ensuring your medical devices remain safe, compliant, and effective within Singapore’s regulatory environment can be challenging. With Andaman Medical’s expert medical device post-market surveillance in Singapore, we manage the entire process on your behalf. From meeting local requirements to monitoring ongoing device performance and safety, we help keep your products compliant, reliable, and ready for long-term success in the Singaporean market.

Why Get Medical Devices PMS in Singapore

Post-market surveillance is about more than meeting regulatory requirements. It plays a vital role in protecting patient safety, maintaining market access, and strengthening trust in your brand.

At Andaman Medical, we offer comprehensive PMS solutions tailored to Singapore’s regulatory landscape. With our deep understanding of local Health Sciences Authority (HSA) requirements and the medical device industry, we help you ensure your device’s continued safety and compliance. Our services also support proactive risk management, product quality improvement, and better patient outcomes.

Here’s how Andaman Medical helps you overcome the challenges of medical device post-market surveillance in Singapore:

Medical Device PMS Requirements in Singapore

Mandatory Reporting of Adverse Events (AE) by dealers is a central part of post-market surveillance of medical devices 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 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).

Adverse Event (AE) reporting requirements in Singapore

The following medical device associated AEs must be reported to the HSA:
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
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.

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

Field Safety Correction Action (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
As part of PMS for medical devices, 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.

Why Choose Andaman Medical for Your Medical Device Post-Market Surveillance in Singapore

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