PSUR for No-Predicate Devices in India: 6-Monthly Reporting

1. Key takeaways

Under Rule 65(b) and (d) of the Medical Devices Rules, 2017, holders of a Form MD-27 licence — the licence for devices with no predicate — must submit a Periodic Safety Update Report (PSUR) from the date the device is placed on the market: every 6 months for the first 2 years, and annually for the following 2 years. In parallel, the same holders must report suspected unexpected serious adverse events within 15 days. The PSUR cadence is therefore fixed, finite and fully schedulable from the day of market entry, and it exists specifically because no-predicate devices carry the thinnest evidence base at approval.

• Rule 65(b) sets the PSUR frequency: every 6 months for the first 2 years from the date of placing on the market, then annually for the next 2 years.
• Rule 65(d) requires SUSAE reporting, aligned with the 15-day formulation of Rule 26(ii) and Rule 38.
• The obligation applies to no-predicate devices, which must first obtain an MD-27 licence under Rule 36(6).
• The industry-compiled PSUR content list runs from the safety summary through signal analysis to conclusions and recommendations.
• The industry-compiled record retention periods are: adverse event reports for the device lifetime plus 2 years; complaint files at least 5 years; PSURs indefinitely; distribution records at least 5 years.

2. Legal basis

The PSUR obligation sits inside a cluster of rules that connect the licence form, the reporting frequency and the event reporting duty. Some elements come directly from the rules; the content list and retention periods come from industry compilation of third-level sources and are marked as such below.

The separation between the statutory rows and the compiled rows matters for planning. The frequency and the 15-day event duty are binding; the content list and retention figures are a practical estimate of what the authority expects, useful for building the template but not to be cited as rule text.

3. Expert insights

Insight one: the PSUR is an obligation exclusive to no-predicate devices. Holders of ordinary MD-15 licences do not carry this 6-monthly PSUR duty. It is an enhanced surveillance instrument created specifically for devices approved without a predicate — the category with the weakest evidence base at the time of authorisation. The logic is straightforward: where the approval rested on less prior clinical experience, the regulator compensates by demanding more frequent structured updates from the market. Companies transitioning between licence types should check whether the duty follows the device or the licence, and plan accordingly.

Insight two: the total is 6 reports within 4 years. Two years at two reports per year yields 4 PSURs, and the following two years at one per year yields 2 more, for a total of 6. This is a fixed workload that can be entered into the project calendar on the day the MD-27 licence is granted, years before the first report falls due. Companies that discover the cadence mid-cycle are forced into compressed data collection; companies that diarise it at licence stage spread the effort evenly across the whole period.

Insight three: the value of the PSUR lies in signal analysis, not in document submission. Within the industry-compiled content list, event trends and signal analysis and the updated benefit-risk evaluation are the core. A PSUR written as a running log of complaints wastes its most useful function — it is, in substance, the company’s periodic self-inspection. The trend sections are where a drift in failure modes, a shift in user population or an emerging use error first becomes visible to the company itself, often before it becomes visible to the regulator.

Insight four: cumulative sales and exposure data must match Indian reality. Global figures cannot substitute for India-specific exposure. If the company has no local distribution records for India, the exposure chapter of the PSUR becomes distorted, and every rate calculated against that denominator loses meaning. The exposure section is only as good as the flow-of-goods data behind it, which is why the distribution record-keeping duty and the PSUR duty are practically inseparable.

4. Practical recommendations

• Create the PSUR calendar on the very day the client receives the MD-27 licence: schedule the due dates of all 6 reports at once, so that no deadline depends on anyone remembering the cadence.
• Start data collection for each report 45 days before its due date, which leaves room for the signal analysis and the benefit-risk update rather than leaving only enough time for formatting.
• Require the Indian agent to provide flow-of-goods data quarterly — which hospitals the devices went to and in what quantities — as the basis for the exposure estimate.
• Structure each PSUR around the trend and signal sections, using the complaint data to answer whether the device’s risk profile has changed, rather than assembling the report as a chronological log.
• Maintain the 15-day SUSAE reporting duty in parallel, and keep the adverse event records, complaint files and distribution records for at least the industry-compiled retention periods listed above.

Without the quarterly flow data, the PSUR has no real content: the exposure numbers become guesses, and a report built on guessed denominators cannot support the signal analysis that gives the document its value. Securing the data feed is therefore the first operational step, ahead of any template work.

5. Verification checklist

• ☐ It has been confirmed that the product is a no-predicate device holding an MD-27 licence
• ☐ The PSUR calendar schedules the due dates of all 6 reports
• ☐ A data collection reminder is set 45 days before each due date
• ☐ The Indian agent has agreed to provide quarterly flow-of-goods data
• ☐ The parallel 15-day SUSAE reporting duty has been established

Regulatory information verified as of 27 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including India. Our team prepares dossiers to CDSCO expectations, manages SUGAM submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com