In India, a medical device registration certificate (Form 41) is valid for 3 years from the date of issue. Applications for re-registration should be submitted 9 months before the registration certificate expires. Recently, the Indian government has been focusing more on post market surveillance for re-registration. Adverse events and the corrective actions taken need to be carefully documented while the device is on the market in India. Recent Indian labeling standards also require a 1-800 or toll free telephone number for complaint reporting.
For the product performance section of the re-registration application, the Indian government is asking for details of the product sales and adverse events that occurred in India while the product is being sold over the last few years. Key items include procedures in place for post market surveillance (PMS), global recall status, root cause of any complaints or adverse events as well as CAPA by manufacturers for these complaints. If your company cannot provide this information, your product will likely not be approved for re-registration in India.
Instead of setting up an in-country office, many Western medical device companies register their products in India through a distributor or local agent. However, you often cannot rely on your local Indian distributor to collect this PMS data for you. Most Indian distributors are not aware of Indian and global regulatory requirements for complaint handling or for the quality of information that needs to be collected. Additionally, if a doctor reports a problem, the distributor is likely to simply replace the device product for free. If the doctor is happy with a replacement — or isn’t going to buy the device again anyway — why would the local Indian distributor keep PMS data?
Doctors can also directly report adverse events to the Indian government, so your distributor may not even know a complaint or adverse event has taken place. When adverse events are reported to the Indian government, the device may be required to be withdrawn from the market. Furthermore, if your device is for sale in the U.S. or EU, global PMS data is required. Not providing your PMS data from India could result in a 483 — and a closing of your manufacturing plant, reduction in sales and an administrative nightmare.
Having correct, complete Indian PMS data is crucial for keeping your medical device on the market. If you don’t have a foreign office set up in India that is overseeing your sales there, make sure that your distributor or local agent is keeping track of PMS information.
PBM can act as your local agent in India, and we have set up a call center in India to capture this important post market data.