PMS is and importance for medical devices
Post Marketing Surveillance (PMS) is a key component of the regulatory framework for medical devices in India. It is a systematic procedure for monitoring the safety and effectiveness of medical devices shortly after they have been released into the market by collecting and analyzing data from multiple sources such as adverse event reports, patient feedback, and device performance data. This aids in the discovery of any potential device flaws that were not detected during the pre-market testing phase, as well as long-term safety concerns or product issues that may require corrective action and to improve regulatory policies and guidelines.
Role of the Central Drugs Standard Control Organization (CDSCO) in PMS
In India, the regulatory agency Central Drugs Standard Control Organization (CDSCO) plays a crucial to maintain compliance with PMS specifications. They ensure that medical device manufacturers undertake post-market surveillance studies and submit regular PMS reports, detailing the results of their surveillance activities.The Ministry of Health and Family Welfare (MoHFW), Government of India (GoI), authorized and launched the Materiovigilance Programme of India (MvPI) in the country in 2015, with only the objective of monitoring the safety and assuring the quality of medical devices used in the country. MvPI has established monitoring centers and has made available an adverse event reporting form for use by manufacturers/importers/distributors, healthcare professionals, and others.Failure to comply with PMS requirements can result in penalties, fines, or even product recalls.
Specific requirements for PMS in India on Medical devices
The specific requirements for PMS in India are outlined in the Medical Device Rules 2017, which apply to all medical devices marketed in the country. These rules are designed to ensure that medical devices remain safe and effective over time and that any safety concerns or product issues are identified and addressed promptly. The dossier should include the Post Marketing Surveillance Reporting procedures and data collected by the manufacturer encompassing the details of the complaints received and corrective and Preventive actions- (FSCA and FSN) taken for the same.
- The responsible person should sign and date any information that is provided as part of the dossier.
- Batch Release Certificates and Certificates of Analysis of finished product for minimum 3 consecutive batches should be submitted.
- All certificates presented must be valid at the time of submission.
- Any information that is not pertinent to the subject device may be stated as “Not Applicable” in the relevant Sections/Columns of the aforementioned structure, and the reasons for non-applicability should be specified.
Data types gathered and examined during PMS for the purpose of identifying any safety concerns or product issues
During PMS, various types of data are collected and analyzed, including:
- Adverse event reports: These reports detail any unexpected or unfavourable side effects that may arise while using a medical device. Product malfunctions, patient injuries, and other safety concerns are some examples of adverse events.
- Patient feedback: This includes feedback from both patients who have used the device and healthcare experts who have clinical experience with it.
- Device performance data: This includes information on the device's effectiveness in treating specific conditions, as well as information on the device's dependability, durability, and other performance metrics.
- Complaints and service data: This includes information on any complaints or issues related to the device, as well as data on the service and support provided by the manufacturer.
Future of PMS for medical devices in India
A multitude of factors, including emerging technologies, changing regulatory frameworks, and increased collaboration between regulatory agencies and medical device manufacturers, are likely to affect the future of Post-Marketing Surveillance (PMS) for medical devices in India. The rising use of digital technology and artificial intelligence (AI) in medical devices is one important trend that is anticipated to leave an impact on PMS in India. These technologies open new possibilities for PMS by providing real-time data on device functioning and patient outcomes, as well as making it easier to figure out patterns and trends in adverse events. By analyzing this data, manufacturers and regulatory bodies can quickly identify and address any safety concerns or product flaws more rapidly.
PMS plays a critical role in ensuring the safety and efficacy of medical devices in India, and it is imperative that manufacturers comply with the regulatory requirements to maintain patient trust and confidence in medical devices. While there are difficulties in adopting an effective PMS. Contact our regulatory expert immediately to learn more about PMS in India.