India Recalls: Rule 89 and CLA Directions

1. Key takeaways

India’s recall obligations operate on two levels. The voluntary level: where a device may pose a risk to users or patients, Rule 89 requires the withdrawal from the market and from patients to be started immediately, with the reasons stated and the controlling authority informed. The directive level: where the Central Licensing Authority (CLA) is satisfied that a device does not conform to the requirements, it may, under Rule 38(2), direct that the entire batch not be sold or that it be recalled from the market, including from hospitals. A compliant recall process in India therefore has to be ready in two directions at once — the company must be able to move on its own judgement without waiting for a deadline, and it must be able to execute a regulator’s direction across distribution channels that reach into hospitals.

• Rule 89 of the MDR 2017 sets no day count for the voluntary layer: the trigger is the judgement that the device may pose a risk, and the response must begin at once.
• Rule 38(2) gives the CLA batch-level powers: an entire batch may be barred from sale or offer for sale, or ordered recalled from the market including from hospitals.
• Rule 26(vi) places a matching duty on the manufacturing side: when told by the SLA or CLA that a batch does not conform and directed accordingly, the holder must withdraw the remaining stock and recall what has already been distributed as far as possible.
• Foreign regulatory action feeds the same machinery: Rule 38(1)(ii) and (iii) require a report within 15 days and an immediate stop to shipment.
• A recall must also be reported: under Rule 26(ii), a recall arising from a SUSAE must be reported together with the event within 15 days.

2. Legal basis

The recall framework in the Medical Devices Rules, 2017 is distributed across several provisions rather than consolidated in one place, and each provision addresses a different actor in a different posture: the licence holder acting on its own risk assessment, the CLA acting on its own findings, and the manufacturing-side holder reacting to a regulator’s determination. The table below maps each limb of the framework to its source and its content.

The practical reading of this table is that recall in India is never a single obligation with a single deadline. One recall event can simultaneously engage the immediate-action duty, the 15-day SUSAE report, the foreign-action report and the stop-shipment duty, and the same internal case file must serve all of them.

3. Expert insights

Insight one: the word “immediately” carries the heaviest weight in the Indian recall rules. Rule 89 sets no number of days. It requires the withdrawal to be initiated at the moment the judgement forms that the device may pose a risk — not when the investigation is finished, not when head office has approved, and not when the evidence is complete. Because the trigger is a possibility rather than a confirmation, companies that build their recall process around an evidence-gathering phase before any market action will find that the rule has already been breached by the time their internal review concludes.

Insight two: the recall duty falls on the licence holder and the authorised agent. For imported products, the executing party for Rule 38(1)(iii) is the authorised agent in India. This means the foreign manufacturer must agree with its Indian agent, in advance and in writing, on who has the authority to initiate a recall, how the costs are borne, and how the execution will run. An agent relationship negotiated only around registration and import formalities will not have the machinery in place when a recall arrives, and the delay will be measured in days the rules do not allow.

Insight three: hospital stock is inside the recall scope. The wording of Rule 38(2) is a recall from the market, including from hospitals. Devices differ from pharmaceuticals in that many are already installed, configured or implanted when the recall decision is made, and the practical complexity of executing the recall is far higher as a result. Recovering a device from a hospital store, a theatre or a patient is a different exercise from pulling boxes from a distributor’s warehouse, and the scope of the direction should be planned for at its widest reading.

Insight four: the recall and the vigilance report are two faces of one event. When a recall happens, it simultaneously triggers the 15-day reporting duty of Rule 26(ii) if it arises from a SUSAE, and the foreign-action reporting duty of Rule 38(1)(ii) if the same action is being taken abroad. Treating the recall as a logistics exercise alone — moving product without running the parallel reporting tracks — leaves the company exposed on the reporting side even when the market side has been handled perfectly.

4. Practical recommendations

• Require, as a non-negotiable clause in the Indian agent agreement, a recall clause covering: the manufacturer’s right to direct a recall directly; the agent’s obligation to initiate within 24 hours of receiving the instruction; the allocation of recall costs and liabilities; and the ownership of the reporting obligations after the recall is completed.
• Prepare an India-specific field safety notice (FSN) template in advance and finalise the English wording, the contacts and the return method before any event occurs — drafting the notice during a live recall means the 15-day window is gone before the document exists.
• Build the recall execution plan around hospital-level recovery, not distributor-level recovery alone, reflecting the express wording of Rule 38(2).
• Keep a single case record per recall event that simultaneously feeds the immediate-action file, the 15-day SUSAE report, the foreign-action report and the stop-shipment record.
• Train the agent’s staff and the company’s India-facing team on the four trigger paths in the table above, so that the parallel obligations are recognised at the moment the event opens.

The common thread across these measures is preparation before the event. A recall that begins with a negotiated contract, a finished template and a rehearsed workflow starts inside the 24-hour mark; a recall that begins with a blank page starts after the deadlines have already expired.

5. Verification checklist

• ☐ The agent agreement contains the recall initiation authority and a 24-hour response requirement
• ☐ An India-specific FSN template has been finalised in advance
• ☐ The allocation of recall costs and liabilities has been agreed
• ☐ The team understands the recall scope expressed as including hospitals
• ☐ Recalls have been entered on the trigger list for the 15-day reporting duty

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