Posted by The safety and performance of medical devices, once they are marketed to the public, is critical. However, it is not possible to identify all flaws during the pre-market testing phase. Post-marketing surveillance for medical devices is crucial in discovering long-term safety concerns that need corrective action.
Given the essential role of post-marketing surveillance (PMS), India has strengthened its regulatory framework concerning it. Keep reading as we delve into more details about PMS for medical devices in India.
What Is Post-Marketing Surveillance of Devices in India
Post-marketing surveillance of medical devices is performed after they are approved to be used by the public in India. The regulations governing it are present under the Medical Devices Rules 2017.
PMS for medical devices in India is a systematic procedure that monitors the performance and safety of the devices by collating data from various sources. These include patient feedback, adverse event reports, and device performance data. Post-marketing surveillance helps healthcare professionals and manufacturers discover potential flaws in the devices that couldn’t be detected during the pre-marketing testing stage.
Who Monitors Post-Marketing Surveillance?
The Central Drugs Standard Control Organization (CDSCO) is a National Regulatory Authority that monitors post-market surveillance for medical devices in collaboration with the Indian Pharmacopoeia Commission (IPC) under the Materiovigilance Programme of India (MvPI).
Indian Pharmacopoeia Commission (IPC) currently functions as the National Coordinating Centre (NCC). It is designated as the WHO collaboration center for pharmacovigilance, including a clinical device in regulatory services and public health programs.
Medical Device Adverse Event Monitoring Centres (MDMCs) are established in multiple medical institutions throughout India.
What Is the Post-Marketing Surveillance Method?
Various strategies are used to perform PMS for medical devices in India. As mentioned earlier the Materiovigilance Programme of India, which is under the CDSCO and IPC oversee post-marketing surveillance. It identifies safety concerns and suitable responses to safeguard the health of patients.
There are several strategies used to monitor PMS under MvPI. These are explained below.
1. Risk-Based Monitoring
Creating a risk management plan aligned to the risk category of the medical device is important. It is developed throughout the lifecycle of the product to recognize and correct potential safety risks.
Risk-based monitoring involves the ongoing collection of safety data and the assessment of risk-benefit profiles. It also includes timely communication of risks to the healthcare community and the patients.
2. Data Mining and Analysis
MvPI databases consist of data in various formats and standards from diverse sources. These include spontaneous reports and/or clinical investigations. Data mining and statistical analysis of this data are performed to analyze safety signals and their severity.
Data mining and analysis involves decoding, cleaning, and normalization of data sets. This allows the user to gain meaningful insights about safety concerns. This analysis is performed throughout the lifecycle of the product to ensure its safety.
3. Registry Programs
Diseases and product registries provide surveillance for a large patient population. This surveillance includes age, gender, and comorbidities. It gives data related to prescription patterns and off-label uses. Registry programs thus offer real-world data ensuring that any safety concerns do not go unnoticed.
What Are the Two Types of Post-Market Surveillance Activities?
Post-marketing surveillance activities can be divided into two categories. The manufacturer chooses the activity based on the risk class of the medical device. The two types of PMS activities are explained below.
1. Passive (or Reactive) PMS Activities
Passive PMS activities are what the manufacturer implements as a response to an external event. The event can be anything, such as recognition of issues in production, complaints, reports of device misuse, etc.
2. Proactive PMS Activities
Proactive PMS activities include activities implemented by the manufacturer to actively gather data about the device. This can be data about post-market studies, post-market clinical follow-up activities, feedback from users, etc.
What Is the Difference Between Post-Marketing Surveillance and Materiovigilance?
Both post-marketing surveillance and Materiovigilance focus on procedures that track the safety of medical devices. Due to this, they are sometimes used interchangeably. However, they differ from each other in key parameters. The table below will help you understand the differences between them.
|
Parameter |
Post-Marketing Surveillance |
Materiovigilance |
| 1. Processes Involved | Post-marketing surveillance involves continuous monitoring of the safety and performance of the medical device after it has been approved for use. | Materiovigilance is a set of processes related to the detection, evaluation, comprehension, and prevention of negative effects of medical device-related problems. |
| 2. Scope of Work | Post-marketing surveillance focuses on monitoring the total performance and safety of the medical device by those using it in the real world. It includes problems related to the device’s manufacture, labeling, and distribution. | The focus of Materiovigilance is narrower. It concentrates its activities on the detection and evaluation of adverse events and problems related to the product’s safety.
|
| 3. Reporting Requirements | Post-marketing surveillance involves regular reporting of safety information to regulatory institutions. | Materiovigilance is mandated to report all instances of suspected adverse events to regulatory authorities. |
| 4. Time | The time period of post-marketing surveillance can stretch over the entire lifecycle of the medical device. | Materiovigilance activities are the most active during the initial stages and years of the release of the product in the market. |
Summing up
Usually, it is very difficult to foresee all potential risks, side effects, and uses of a medical device before it is released. Post-marketing surveillance helps predict the safety of the medical device in the real world along with opportunities for improvements and innovation in its development and use. Thus, it is crucial to enhance the medical device and make it more reliable and consistent for its consumers. If you want to take any kind medical device regulatory services So, you can also easily connect with our Dueran Consultant team.
Frequently Asked Questions (FAQ’S)
1. Does ISO 13485 require post-market surveillance?
Yes, post-marketing surveillance is a crucial part of ISO 13485 as it is present in the requirements laid out by it. Post-marketing surveillance identifies new opportunities for improvement concerning the medical device as per the ISO 13485 as well as gives feedback for the design and development change processes of the device.
2. Does the FDA require post-market surveillance of medical devices?
Yes, section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to require manufacturers to conduct post-marketing surveillance. This is required to be done during the approval or clearance or any time after specific class II or class III devices.
3. How long is post-marketing surveillance?
Post-marketing surveillance is long-term in nature. It begins after the medical device is released into the market and goes throughout the lifecycle of the product.
