Medical Devices Post-Market Surveillance in the Philippines
Why Get Medical Devices PMS in the Philippines
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 the Philippines
In accordance with Annex 5 of the AMDD, the following is required as part of a PMAS in the Philippines:
Importation and/or distribution records
Complaint records
Adverse Event (AE) reporting criteria and reporting format
Field Safety Corrective Action (FSCA) reporting format
All medical device establishments, manufacturers, distributors, importers, exporters, wholesalers must have a Quality Management System (QMS) and relevant documentation in place. This is checked and audited by the Philippines FDA during its routine inspections. The QMS must include an established Risk Management Plan (RMP) and Standard Operating Procedures (SOPs) together with their related forms for Good Storage and Distribution, Complaint Handling, Product Recalls, Medical Device Disposal/Destruction.
IMPORTANT REMINDER
Medical Device PMS Requirements in the Philippines
In accordance with Annex 5 of the AMDD, the following is required as part of a PMAS in the Philippines:
Importation and/or distribution records | Complaint records | Adverse Event (AE) reporting criteria and reporting format | Field Safety Corrective Action (FSCA) reporting format |
IMPORTANT REMINDER
Adverse Event reporting requirements in the Philippines
Adverse events | Report within |
---|---|
Serious threat to public health: Immediately or not later than 48 hours | 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 |
- An Adverse Event has occurred
- The device is associated with the AE
- The AE led to one of the following outcomes:
- A serious threat to public health
- Death of a patient, user or other person
- No death or serious occurred but the event that might lead to death or serious injury of a patient user or other person if the event recurs.
Any adverse event occurring outside the Philippines do not qualify for reporting to the PFDA, unless the user is Filipino and the device is obtained from the Philippines, or it is otherwise requested. The country of occurrence should be stated.