India Import Licence Process: Form MD-14 Application and Form MD-15 Grant

1. Key takeaways

The application form for an import licence covering medical devices in India is Form MD-14, and the licence once granted is issued as Form MD-15. Both the receipt of the application and its final approval sit with the Central Licensing Authority (CLA), which is the CDSCO headquarters, and this allocation does not depend on risk classification: regardless of the risk class, every import licence is handled centrally. The statutory review period is nine months from the date of the application (Rule 36(1)), and that clock runs whether or not an inspection of the overseas manufacturing site is carried out. This matters for planning, because many applicants assume that a site inspection will extend the statutory timeline; under the Rules it does not. The nine months is the government-side clock, and everything the applicant does before filing, and every round of deficiency clarification after filing, sits outside it. Understanding where Form MD-14 ends and Form MD-15 begins, and which authority signs each step, is the foundation of any India import project, because it determines which fees apply, which documents are mandatory, and who at CDSCO can be approached when a query arrives. For overseas manufacturers without a local presence, the application is routed through an Authorised Indian Agent, which adds its own coordination layer to the timeline.

2. Legal basis

The table below consolidates the provisions that govern the import licence route, so that each operational question can be traced back to a specific rule or official source rather than to market rumour.

3. Expert insights

Insight one: the phrase “nine months” appears in two formulations in the Indian framework. The CDSCO draft guidance on IVD imports expresses the MD-14 timeline as 270 days, which is the same measure as the “nine months” of Rule 36(1), simply stated in days rather than months. When reviewing documents, there is no need to agonise over the difference; the practical point is to recognise that a reference to 270 days is a reference to the statutory review period itself. Teams that miss this equivalence sometimes schedule around two different clocks and end up with contradictory plans.

Insight two: the nine months exclude three stretches of time. They exclude the time the company spends preparing its dossier, they exclude the round-trip time consumed by deficiency queries and responses, and they exclude any period in which the company must carry out a clinical investigation that has been required of it. Treating the nine months as the total project duration is the single most common scheduling error in India projects, and it propagates into sales forecasts, inventory plans and distributor agreements.

Insight three: the overseas inspection may fall before or after grant. CDSCO has stated clearly that the inspection of an overseas manufacturing site may be conducted before or after the licence is granted, as the authority considers necessary. The consequence is important: receiving MD-15 does not mean the inspection risk has been discharged. A manufacturer can be licensed, shipping, and still receive an inspection request afterwards, so the budget and the site readiness plan must both remain live well beyond the grant date.

Insight four: products from the same overseas site carry an exclusivity feature. According to a textual analysis of MDR 2017 (the Nishith Desai analysis of the Medical Devices Rules, 2017 — a third-level source; written confirmation from the CLA is recommended before signing contracts), where a licensee has been permitted to import some products from a given manufacturing site, the remaining products manufactured at that site must mandatorily be licensed to the same licensed importer. This is a structural provision with strong binding force on manufacturers, because it ties a physical site to a licence holder and thereby shapes distributor and agent strategy across the entire portfolio.

4. Practical recommendations

• Build the India schedule as the sum of three stretches: dossier preparation of two to four months (including the PoA certification chain and, depending on the product category, a three-batch performance evaluation report), plus the statutory review period of nine months, plus a clarification buffer of two to four months.
• For Class C/D products without a free sale certificate from one of the six reference jurisdictions, add the clinical investigation period on top of the three stretches before committing to launch dates.
• Align this schedule with the customer’s sales plan at the project kick-off meeting, so that production planning does not assume a nine-month total cycle and create mismatches between inventory and distribution channels.
• Keep the overseas inspection contingency and the USD 6,000 inspection fee inside the project budget from day one, since the inspection may arrive after grant.
• Address the site-based exclusivity provision in the agency or distribution agreement before signature, not after a dispute arises.

5. Verification checklist

• □ MD-14 has been submitted to the CLA by a qualified Authorised Indian Agent
• □ Fees have been paid in full under the Second Schedule (site fee plus per-device fee)
• □ The schedule has been calculated as preparation plus statutory review plus clarification
• □ The overseas site inspection contingency and the USD 6,000 inspection fee are in the budget
• □ The structural exclusivity provision for licence holding has been addressed in the agency agreement

Regulatory information verified as of October 27, 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