Medical Device Post Market Surveillance (PMS) in Malaysia
Keeping your medical devices safe, compliant, and reliable in Malaysia’s regulatory landscape can be challenging. With Andaman Medical’s expert medical device post-market surveillance in Malaysia, we take the stress off your shoulders by managing the entire process for you. From navigating local regulations to demonstrating ongoing device performance and safety, we ensure your products remain compliant, reliable, and ready for market success.
Why Get Medical Device PMS in Malaysia?
At Andaman Medical, we provide comprehensive PMS solutions to help you navigate Malaysia’s regulatory landscape with ease. Leveraging our expertise in local regulations and the medical device industry, we ensure your device’s safety and compliance while proactively mitigating risks, improving product quality, and enhancing patient outcomes.
Here’s how Andaman Medical helps you solve the challenges of medical device post-market surveillance in Malaysia:
Regulatory Compliance
Regulatory Compliance
PMS is a mandatory requirement by the Ministry of Health to ensure the safety, effectiveness, and quality of medical devices. Regular monitoring maintains compliance and avoids penalties. We manage your PMS activities, ensuring full compliance while mitigating risks of non-compliance and penalties.
Early Detection of Issues
Early Detection of Issues
Post-market surveillance identifies potential safety concerns, performance issues, or adverse events early. This proactive approach prevents widespread problems and ensures patient safety. We conduct monitoring and reporting to identify risks, enabling timely corrective actions to protect patients and your product’s reputation.
Improvement of Product Quality
Improvement of Product Quality
Monitoring device performance in real-world settings provides valuable feedback to improve product design, manufacturing, and quality. These enhancements lead to better patient outcomes and stronger market presence. We analyse PMS data to deliver insights that refine your products and maintain high-quality standards.
Maintaining Market Authorisation
Maintaining Market Authorisation
Effective PMS is essential for maintaining your device’s market authorisation. Meeting surveillance requirements demonstrates your commitment to safety and helps avoid losing regulatory approval. We ensure you meet all PMS obligations, keeping your device compliant and authorized in Malaysia.
Building Trust with Healthcare Providers
Building Trust with Healthcare Providers
PMS data demonstrates ongoing device safety and performance, building confidence among healthcare professionals. This trust leads to increased adoption of your products and stronger relationships. We deliver PMS reports and insights that enhance credibility and strengthen trust with healthcare providers.
Risk Management and Mitigation
Risk Management and Mitigation
Post-market surveillance helps identify and address risks, enabling corrective actions to prevent recalls, legal issues, and reputational damage. We manage risks by identifying issues, implementing corrective measures, and protecting your brand.
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
What You Need to Know About Medical Device PMS in Malaysia
Mandatory Problem Reporting
Mandatory problem reporting, also known as Adverse Event (AE) reporting under the ASEAN Medical Device Directive (AMDD), is a post-market risk assessment measure designed to ensure the continued safe use of medical devices in Malaysia. As part of the post-market surveillance (PMS) system, this includes:
- Submitting a mandatory problem report to the Malaysian Medical Device Authority (MDA) when an incident involving a medical device occurs, either inside or outside Malaysia, if the device is registered in Malaysia.*
- Conducting an investigation to determine the root cause of the incident.
- Implementing Corrective and Preventive Actions (CAPA) to mitigate the risk of recurrence.
*Note: The requirement to submit a mandatory report does not apply to incidents outside Malaysia if the incident has already been reported to the relevant regulatory agency in that country, and appropriate field corrective actions have been undertaken on all affected devices placed on the Malaysian market, as specified by Regulation 5(7) of the Medical Device (Duties and Obligations of Establishments) Regulations 2019.
Why Choose Andaman Medical for Your Medical Device Post-Market Surveillance in Malaysia
