No-Predicate Class C/D Devices in India: MD-22, MD-23, MD-26 and MD-27 Two-Stage Licensing

1. Key takeaways

For devices that reach the Indian market without any marketed comparator, the framework does not offer a single-step licence. A device with no predicate device in India — that is, a device for which no corresponding device is already marketed in the country — follows a two-stage licensing route. In the first stage, an application on MD-22 leads to a clinical investigation licence issued on MD-23, with a fee of INR 100,000. In the second stage, an application on MD-26 leads to the manufacturing or import licence issued on MD-27. Until MD-27 has been obtained, no import licence of any class may be issued for the device. This sequencing is not administrative housekeeping: it means the clinical evidence and the market authorisation are examined in separate reviews, by the same authority but at different moments, and a failure or delay in either stage stops the entire project. Companies accustomed to jurisdictions where a single dossier review covers both the clinical package and the market authorisation routinely underestimate how differently the two stages must be planned, staffed and budgeted in India, and how much of the project risk concentrates in the first stage, before any commercial return is in sight.

2. Legal basis

The table below traces the two-stage route through the rules, together with the exemptions that can shorten or remove the clinical stage and the post-market reporting duties that attach once the licence is granted.

3. Expert insights

Insight one: two stages mean two reviews, and two chances to be queried. The first review asks whether the device may be tried in human subjects at all; the second asks whether the results of that trial are sufficient to support market access. If either stage stalls, the entire project stands still, and the two stages cannot be compressed into one another or run fully in parallel under the current framework.

Insight two: the two-year condition is a time barrier, not a paperwork barrier. Approval in one of the six reference jurisdictions can be obtained within months, but the requirement of two years of marketing in that country cannot be bought with money or documentation; it can only be waited out. For Class C/D products without a predicate, this is the hardest time lock on the road into India, and it cannot be accelerated by any submission strategy.

Insight three: the public interest exemption is a narrow door. The proviso to Rule 63(1) allows the CLA to exempt or shorten the clinical investigation for life-threatening diseases, national emergencies, epidemics and similar situations. It has real value for genuinely innovative products addressing such conditions, but it is discretionary: it is a power the authority holds, not a right the company can claim, and applications should be framed accordingly rather than assumed.

Insight four: obtaining MD-27 is only the beginning. Under Rule 65(b)(d), the holder of an MD-27 licence must continue to submit PSURs from the date of marketing: every six months for the first two years, and annually for the following two years. This PSUR burden is one that holders of ordinary device licences do not carry, and it must be resourced within the pharmacovigilance function from the day the product first ships.

4. Practical recommendations

• The first step in any no-predicate project is to determine whether a predicate truly exists: search the products already licensed by CDSCO for the same name, the same intended use and the same technical features, rather than accepting the customer’s assertion that the product is new. The time and fees this step saves often exceed everything that follows.
• Once the absence of a predicate is confirmed, prepare two tracks simultaneously: the main track, being the MD-22 clinical investigation protocol, and a backup track of the technical documentation, ready to convert immediately into a conventional MD-14 route if the CLA exempts or shortens the clinical investigation under the public interest provision.
• Build the PSUR calendar at the same time as the licensing plan, so the post-market rhythm is visible before commercial launch rather than negotiated after it.
• Frame any request under the public interest proviso as an application for the authority’s discretion, with supporting justification, never as an entitlement.

5. Verification checklist

• □ A predicate search has been run against CDSCO-licensed products and the search record retained
• □ The need for an MD-22 → MD-23 clinical investigation has been confirmed (fee INR 100,000)
• □ Whether six-jurisdiction approval plus two years of marketing applies has been verified (Rule 63(1) proviso)
• □ The second-stage MD-26 → MD-27 application has been planned
• □ A PSUR calendar has been established (every six months for the first two years, annually for the next two)

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