India Licence Retention Fee: 90-Day Grace and 2% per Month

1. Key takeaways

An Indian import licence (Form MD-15) is valid in perpetuity, but the holder must pay a licence retention fee for each overseas manufacturing site and each licensed device on every completion of 5 years from the date of issue. Payment may be made within 90 days after the due date, subject to a late fee at 2% per month. If payment is still not made within those 90 days, the licence is deemed to have been automatically cancelled.

• Perpetual validity, periodic payment: the licence never expires, but the retention fee falls due every 5 years.
• Two dimensions: the fee is calculated per overseas manufacturing site and per licensed device, not once per licence.
• 90-day grace with a price: late payment within 90 days is possible, but attracts 2% per month.
• Automatic cancellation: beyond 90 days the licence is deemed cancelled by operation of the rule, without a separate administrative act.

2. Legal basis

The obligation, the grace period and the consequence of default all sit in Rule 37 of the MDR 2017, read with the Second Schedule for the amounts. The table sets out the operative points.

3. Expert insights

Insight 1: perpetual validity is the most frequently misreported feature of the Indian system. Chinese-language sources commonly state that Indian registration certificates are valid for 5 years; that is incorrect. The correct formulation is valid in perpetuity plus a retention fee every 5 years. The practical difference is large: a 5-year validity means a fresh application at each expiry, whereas perpetual validity means no re-application as long as the fee is paid on time.

Insight 2: cancellation is automatic and does not require notification to take effect. Rule 37 is worded so that the licence shall be deemed to have been cancelled. It does not depend on a further administrative decision: once the 90 days pass, the legal position changes immediately, and any import after that point is an import without a licence. There is no grace on the other side of the deadline, and no notice is required before the status changes. The practical consequence is that a company can hold what looks like a valid certificate in its files while the legal basis for importing has already gone, and the gap is usually discovered at the port rather than at head office.

Insight 3: the retention fee is re-paid on two dimensions — site and device. It is not one amount per certificate: each overseas site and each licensed device is counted separately. The wider the product line, the higher the retention fee, and a portfolio that has grown over five years will pay considerably more than it did at first issuance.

Insight 4: all three certificates carry 5-year nodes. The import licence (MD-15), the manufacturing licence (MD-5/MD-9) and the wholesale registration certificate (MD-42) are all valid in perpetuity with a 5-year retention fee. The three nodes may fall in different months, so they need to be managed together rather than remembered individually.

4. Practical recommendations

• Build an India compliance calendar covering all three certificates. GRZAN builds a compliance calendar for clients that records the 5-year nodes of all three certificates and sets three levels of reminder at 6 months, 3 months and 1 month before expiry.
• Calculate the fee on both dimensions before the deadline. The amount should be computed per site and per device so that the payment is correct at the first attempt and does not trigger the late-fee provision.
• Write the retention obligation into the agency agreement. The agreement should state clearly who pays, and who bears responsibility if non-payment leads to cancellation of the licence — a clause that is entirely missing from many agency agreements and is the one most likely to cause serious loss.
• Do not treat the 90-day window as a planning buffer. The window exists to absorb administrative delay, not to extend the payment cycle; using it routinely means paying 2% per month for the privilege.
• Record the issue date, not the approval date, as the starting point. The 5-year cycle runs from the date of issue, which is the date the calendar should be anchored to.

5. Verification checklist

• □ The 5-year retention fee due date has been derived from the date of issue
• □ The fee amount has been calculated on both dimensions (site + device)
• □ Reminders are set at 6, 3 and 1 months before the due date
• □ The agency agreement specifies the retention fee payment duty and the consequences of default
• □ The 5-year nodes of all three certificates are recorded in one register

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