Post-market follow-up studies and safety reports for Indian device makers
TL;DR Longwatch runs the follow-up studies that Indian medical device makers owe the regulator once a new device is on sale. It tracks patients by phone and clinic visit, logs complaints and adverse events, and hands over data ready for each safety report. Small and mid-sized device makers pay per study.
India's Medical Devices Rules make the maker of a new device with no predicate file a Periodic Safety Update Report every six months for the first two years after launch, then once a year for two more years[1]. A report needs real data on how patients fared. Most small Indian device makers have no team to collect it, and the country's device-safety reporting started as a voluntary scheme run through a handful of monitoring centres[2].
The pressure is going up though. In July 2025 the National Medical Commission told every medical college to set up a committee for device adverse events[3]. If you rely on distributor anecdotes then you'll struggle to answer the questions that follow.
What it does, in regulatory terms: post-market data collection and reporting support for the licence holder. Longwatch does not assess device performance clinically or make claims about safety. The manufacturer remains responsible for every report it files with CDSCO.
For each device, Longwatch agrees a follow-up plan with the maker - which patients, how often and which outcomes. Hospitals that use the device enrol consenting patients, and Longwatch's coordinators then call them at set intervals in their language, record outcomes and complaints, and arrange a clinic check when a reply suggests a problem. Where the device claim is about mobility or activity, patients can opt in to share step counts from a basic tracker. Every six months the maker gets clean tables for its safety report.
The seed pitched wearable-based real-world evidence for drug trials and drug safety, and I've narrowed it. Drug safety literature screening is a crowded service, while device makers face a dated legal duty and few vendors built for them.
Patients pay nothing. The device maker pays a set-up fee and a fee per follow-up cycle. There's no published Indian price, so test it. Importers of new devices carry the same duty and are a second buyer. Hospitals get cleaner adverse-event records for the committees the NMC now requires, which is why they may agree to enrol patients.
The NMC directive of July 2025 put device adverse-event committees in every medical college[3]. The DPDP Rules, notified on 14 November 2025, make consented, documented patient contact the expected norm[4]. Indian device makers launching novel products need this data on a fixed timetable from launch day, no matter what.
There's no public count of new-device permissions with PSUR duties, and no figure for what India spends on device post-market services. The firm signal is legal - each such device triggers six reports over four years[1].
The adjacent signal is that device makers already buy clinical software from vendors, one of which claims 8,000+ clinical sites[5]. Count your market device by device.
A Bengaluru vendor sells safety databases, signal detection and data capture software[6]. An Ahmedabad vendor sells data capture and patient-reported outcome tools[5]. Both sell software that the maker still has to run. Global decentralised-trial vendors sell patient apps to large sponsors[7]. The gap is a done-for-you follow-up service priced for an Indian maker with one or two novel devices.
| Difficulty | Moderate (47/100) |
| Starting capital | ₹50–90 L |
| Time to launch | 4–6 months |
The calls and data tables are simple. The hard part is getting hospitals to enrol patients for a maker's study and then keeping those patients answering for two years, which is a lot of polite phone calls. You also need regulatory writers who know what CDSCO expects in a report.
You don't hold a licence yourself. Your clients do, and you work to their legal duties.
Building this outside India? The categories above usually have a local equivalent, so check with your own regulator.
Don't let AI decide whether an event is device-related or serious. That's a safety judgement for the maker and clinicians, and a wrong call ends up in a filing with CDSCO.
Want to work out the AI layer for Longwatch? Talk to Yash →
Here's what can go south -
I think it's a sensible services business for someone from device regulatory affairs or a CRO's medical device team. If you're hoping wearables alone will do the work then it is a poor fit. Prove first that three device makers have a PSUR due in the next 12 months and will pay for follow-up rather than file a thin report.
Plan for roughly ₹50–90 L, mostly coordinators, regulatory writers and the time it takes to enrol the first hospitals.
Not a licence of your own. You need ethics approval at each enrolling hospital and DPDP processor terms, while the maker stays responsible for its safety reports.
Yes. Most regulators expect post-market data from device makers. Check your own country's device rules before you price a study.
The free Longwatch validation kit has the line-by-line capital breakdown, the effort scoring, the device-rules and data-protection checklist, a 14-day validation sprint with pass/fail targets, a 90-day launch plan, 10 interview questions for device makers and hospitals, and 5 assumptions to test. Download the kit →
Thinking about building Longwatch or something close to it? The make-or-break work is keeping patients answering for two years so every report has data, and I'm happy to think that through with you. If you need a hand, you know where to find me. Talk to Yash →
For illustration only. Names are fictional and ideas hypothetical; sourced facts are real but may be out of date. Nothing here is legal, financial or professional advice, and Yash Khatri is not personally liable for any use of it. Read the full disclaimer.