Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Permission for a medical device without a predicate (Form MD-26 / MD-27)

India · Central Drugs Standard Control Organisation · Medical devices

Device: premarket approval by the regulatorHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

120 days

regulation

Steps

5 requirements

What is the Permission for a medical device without a predicate in India?

A device with no predicate device on the Indian market needs permission from the Central Licensing Authority after a clinical investigation. The authority decides within 120 days, extendable by 30 days. The clinical investigation can be skipped when the device is approved in the United Kingdom, the United States, Australia, Canada, Japan or the European Union and has been marketed there for at least two years. New medical devices, including software, with no predicate device, before an import or manufacturing licence.

How much does the Permission for a medical device without a predicate cost?

The permission to conduct a pilot clinical investigation is ₹100,000 for Second Schedule rates in force since 2017.

What are the steps of the Permission for a medical device without a predicate?

1. Clinical investigation permission (90 days); 2. Clinical investigation; 3. Application in Form MD-26; 4. Review and decision (120 days); 5. Request for more information (clock stopped); 6. Permission in Form MD-27; 7. Periodic safety update reports.

Does the Permission for a medical device without a predicate rely on other regulators?

Yes. It relies on approvals from Australia, Canada, European Union, United Kingdom, Japan, United States (shorter review, shorter review, shorter review, shorter review, shorter review, shorter review).

Outcome: Permission in Form MD-27, followed by an import or manufacturing licence.

Legal basis: Medical Devices Rules, 2017, Chapters VII and VIII (rules 51 to 65)

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 300 days end to end with the official step targets, of which up to 90 days are clock stops (time the applicant uses to answer). Targets, not actual times.

Steps

In order, with the official target for each step

1. Clinical investigation permission90 daysThe authority decides on the clinical investigation application within 90 days.
2. Clinical investigationonly in some casesRegistered with the Clinical Trial Registry of India before the first participant is enrolled.
3. Application in Form MD-26
4. Review and decision120 daysWithin 120 days of the application, with a possible 30 day extension.
5. Request for more information (clock stopped)up to 90 days, clock stopped, only in some casesIf the applicant does not answer within 90 days, the authority may reject the application.
6. Permission in Form MD-27
7. Periodic safety update reportsEvery six months for two years, then once a year for two more years.

Requirements

What the applicant must provide or meet

Clinical evaluation

Clinical investigationResults of a clinical investigation under Chapter VII. Class A devices may not need clinical data unless the authority asks for it.
Trial registryClinical investigations are registered with the Clinical Trial Registry of India before enrolment.

Reference approval

Waiver for devices approved in reference countries(in some cases)No clinical investigation results needed if approved in the United Kingdom, the United States, Australia, Canada, Japan or the European Union and marketed there for at least two years, with no expected difference in Indian patients and a post marketing investigation commitment.

Nonclinical data

Relaxed animal data for devices with approved drugs(in some cases)For devices that include a drug already approved in India, some animal study requirements may be relaxed.

After approval

Periodic safety update reportsEvery six months for the first two years, then yearly for two more years, and serious adverse events within 15 days.

Official time targets

Targets, not actual review times

Longest clock stopregulation. If requested information is not given within 90 days, the application may be rejected.	90 days
Legal time limitregulation. May be extended by up to 30 days. This is the time limit written in the rules. It is an official target, not a measured review time.	120 days

Fees

Official amounts in the local currency

Fee	Amount
Permission to conduct a pilot clinical investigationApplication · Second Schedule rates in force since 2017	₹100,000
Permission to conduct a pivotal clinical investigationApplication · Second Schedule rates in force since 2017	₹100,000
Permission to import or manufacture a device without a predicateApplication · Second Schedule rates in force since 2017	₹50,000

Reliance on other regulators

AustraliaShorter reviewApproved by this regulator and marketed there for at least two years, safety data acceptable, no expected difference in Indian patients, and a post marketing clinical investigation commitment.
CanadaShorter reviewApproved by this regulator and marketed there for at least two years, safety data acceptable, no expected difference in Indian patients, and a post marketing clinical investigation commitment.
European UnionShorter reviewApproved by this regulator and marketed there for at least two years, safety data acceptable, no expected difference in Indian patients, and a post marketing clinical investigation commitment.
United KingdomShorter reviewApproved by this regulator and marketed there for at least two years, safety data acceptable, no expected difference in Indian patients, and a post marketing clinical investigation commitment.
JapanShorter reviewApproved by this regulator and marketed there for at least two years, safety data acceptable, no expected difference in Indian patients, and a post marketing clinical investigation commitment.
United StatesShorter reviewApproved by this regulator and marketed there for at least two years, safety data acceptable, no expected difference in Indian patients, and a post marketing clinical investigation commitment.

Rule changes

European Union added to reference countries for devices without a predicateIn force, August 14, 2026, effective August 14, 2026