Post Market Servillance

Post Market Surveillance (PMS) is a crucial aspect of the Indian Medical Device Rule 2017. It involves monitoring the safety and performance of medical devices once they are placed on the market. The goal of PMS is to ensure that medical devices continue to meet safety and performance requirements throughout their lifecycle.

Here are some key points regarding Post Market Surveillance under the Indian Medical Device Rule 2017:

1. Purpose of PMS: The main purpose of PMS is to collect and analyze data on the performance and safety of medical devices in real-world settings. This helps in identifying any potential issues or risks associated with the devices.

2. Responsibilities: Manufacturers are responsible for conducting post-market surveillance activities for their medical devices. They are required to establish a PMS system to collect, review, and report data on the performance of their devices.

3. Reporting Requirements: Manufacturers must report any adverse events, malfunctions, or incidents related to their medical devices to the appropriate regulatory authorities. They are also required to submit periodic safety update reports.

4. Data Collection: Manufacturers should collect data on the clinical performance, adverse events, complaints, and any other relevant information related to their medical devices. This data is used to assess the safety and performance of the devices.

5. Risk Management: Manufacturers must implement a risk management system as part of their post-market surveillance activities. This involves identifying and mitigating any potential risks associated with the use of their medical devices.

Overall, Post Market Surveillance is essential for ensuring the ongoing safety and effectiveness of medical devices in the Indian market. Manufacturers play a key role in monitoring and reporting on the performance of their devices to regulatory authorities.