For FDA approval, an Indian manufacturer usually needs 510(k) clearance, which FDA decides on your evidence rather than your CDSCO licence, and many devices need no 510(k) at all. Every device still needs establishment registration, device listing and a US Agent before it is imported or sold in the US.
Key takeaways
- FDA cleared 84 510(k)s from Indian applicants from January 2023 to September 2026. Radiology, orthopedic and hospital devices led. The yearly count fell from 32 in 2023 to 15 in 2025.
- A CDSCO licence does not replace or shorten a 510(k). Your test reports and quality system can carry over. The licence itself does not.
- Of 298 Indian sites registered with FDA as device manufacturers, 114 list only Class I devices with no 510(k). Many devices are exempt, but Class I does not always mean exempt.
- Indian Traditional 510(k)s took a median of 207 days from receipt to clearance, about 21% longer than typical for the same device types. Only 14% cleared within 90 days.
- The FY2027 510(k) fee is $28,653, or $7,163 for a small business. An Indian company qualifies with a certification from its national tax authority.
How many Indian devices does FDA clear, and which kinds?
We counted every 510(k) that FDA cleared from January 3, 2023 to September 27, 2026, using FDA's public 510(k) data [1]. Applicants in India received 84 clearances, 0.7% of all 12,058. India ranked 18th by country, close to Spain (92), Sweden (85) and Brazil (73).
The 84 clearances went to 57 companies. The yearly count has fallen: 32 in 2023, 28 in 2024, 15 in 2025 and 9 to the end of September 2026 [1].
Indian clearances are spread across many fields [1]:
| FDA review panel | Indian clearances | Share |
|---|---|---|
| Radiology | 20 | 24% |
| Orthopedic | 15 | 18% |
| General hospital | 13 | 15% |
| Dental | 9 | 11% |
| General and plastic surgery | 6 | 7% |
| Gastroenterology and urology | 4 | 5% |
| All others | 17 | 20% |
These are the most common device types. FDA calls each type a product code [1]:
| Device type (product code) | Indian clearances |
|---|---|
| Short-term intravascular catheters (FOZ) | 5 |
| Soft tissue fixation fasteners (MBI) | 5 |
| Radiological image processing systems (LLZ) | 4 |
| Pedicle screw systems (NKB) | 4 |
| Automated radiological image processing software (QIH) | 3 |
| Bone fixation plates (HRS) | 3 |
| Medical image analyzers (MYN) | 3 |
| Piston syringes (FMF) | 3 |
Software is a notable part of the mix. Ten Indian clearances were for radiological image processing or image analysis software (LLZ, QIH and MYN). Our AI device tracker covers AI-enabled devices across all countries.
Our method: we counted cleared decisions where the applicant's address is in India. The applicant is usually the manufacturer. An Indian company that files through a US subsidiary is counted under the US.
Does a CDSCO licence help with FDA clearance?
Not directly. FDA does not accept a CDSCO licence in place of a 510(k). The 510(k) rules apply to every company that must register with FDA, wherever it is [4]. FDA makes its own decision on your evidence. Your CDSCO class (A to D) also does not convert to an FDA class. You find the FDA class from FDA's own classification database [11].
What can carry over is the evidence behind your licence:
- Test reports. FDA accepts reports from Indian labs if they meet its expectations, such as testing to the FDA-recognized version of each standard. The section on test reports below covers this.
- Your quality system. FDA's Quality Management System Regulation took effect on February 2, 2026. It incorporates ISO 13485:2016 by reference [9]. A working ISO 13485 system is a strong base. But FDA says it will not accept an ISO 13485 certificate as a substitute for its own oversight, including inspections [9].
- Clinical data, if you need it. Most 510(k)s include no clinical data. Our analysis of when a 510(k) needs clinical data shows how often they do. FDA can accept data from an Indian clinical study if it followed good clinical practice and you provide the required supporting information [4].
- MDSAP audits. FDA may accept an audit report from the Medical Device Single Audit Program in place of a routine FDA inspection [8]. Any manufacturer can be audited under MDSAP, wherever it is based.
What does not carry over is your comparison device. A 510(k) must compare your device to a predicate that is legally marketed in the US [4]. A device sold only in India cannot be your predicate. For the full picture, see our guide to what a CDSCO licence does and does not change.
Does every Indian device need a 510(k)?
No. This is a common misconception. Each device type has a classification regulation, and it says whether a 510(k) is needed. Most Class I types and some Class II types are exempt [11].
FDA's registration data shows how often this applies. On October 13, 2026, 386 Indian sites were registered with FDA. Of the 298 registered as device manufacturers, 114 (38%) list only Class I devices with no 510(k) or PMA number [2]. Among the most common devices Indian sites list without a 510(k) are manual orthopedic and surgical instruments, instrument trays and operating tables. All of these are exempt. So are some Class II types, such as AC-powered hospital beds and ceiling-mounted surgical lights [2, 11].
Two cautions:
- Class I does not always mean exempt. Surgeon's gloves are Class I, and they still need a 510(k). So do Class II oximeters [11].
- Exemptions have limits. An exempt device still needs a 510(k) if, for example, it has a different intended use or uses a different fundamental scientific technology from other devices of its type. Each classification part sets out these limits, such as 21 CFR 880.9 for hospital devices [4].
Exempt devices still need establishment registration, device listing and a US Agent before they are imported [4]. Contract manufacturers must register and list too, even when another company owns the design [4]. India had 133 sites registered as contract manufacturers [2].
Check your device's product code in FDA's classification database before you plan a 510(k) [11]. Our device classification guide explains how to read an entry.
What are the steps from India to the US market?
For a device that needs a 510(k), the usual order is:
- Confirm the classification. Find the product code, regulation number and class. If you cannot tell, you can ask FDA through a 513(g) request. Its FY2027 fee is $8,596, or $4,298 for a small business [3].
- Choose a predicate. Pick a device legally marketed in the US with the same intended use. Search FDA's 510(k) database by product code. Our predicate guide explains how.
- Plan and run the testing. Test to the FDA-recognized version of each standard, at a lab in India or elsewhere.
- Request small business status early. If your company and its affiliates had gross receipts of no more than $100 million, apply at least 60 days before the 510(k) fee is due [3].
- Build the submission in eSTAR. FDA has required eSTAR for 510(k)s since October 1, 2023 [5]. All content must be in English, including any translated reports [6].
- Pay the fee and submit. FDA must receive the correct fee when you submit, or it will not accept the 510(k) [3]. FDA then has 15 calendar days for its acceptance review [6].
- Answer FDA's questions. If FDA sends an Additional Information request, the review goes on hold. You have up to 180 calendar days to send a complete response, or FDA considers the 510(k) withdrawn [7].
- Receive the clearance letter. Your device is cleared, not approved. Approval is the word for PMA devices.
- Register, list and name a US Agent. Do this before the device is imported. The sections below cover timing and cost, and our importing guide covers customs entry.
Your team runs the testing through labs of your choice. A US Agent and an importer fill the US roles, and you can add a regulatory advisor.
What does FDA clearance cost an Indian manufacturer?
FDA's fees for fiscal year 2027 apply from October 1, 2026 to September 30, 2027 [3]:
| FDA fee (FY2027) | Standard | Small business |
|---|---|---|
| 510(k) | $28,653 | $7,163 |
| 513(g) request for classification | $8,596 | $4,298 |
| De Novo request | $191,020 | $47,755 |
| Annual establishment registration | $13,785 | $13,785 |
The small business rate cuts the 510(k) fee by three quarters. To get it, a company outside the US sends FDA a MDUFA Small Business Request form and a certification from its national tax authority. For an Indian company, that is the Income Tax Department. The certification must show gross receipts for the most recent tax year in both US dollars and rupees, the exchange rate used and the dates covered. Each affiliate needs its own certification [3].
Small business status lasts one fiscal year. Status for FY2026 ended on September 30, 2026, so you must qualify again for FY2027 [3]. Our small business guide walks through the request.
The annual registration fee has no small business rate. FDA may waive it only for a business with no more than $1 million in gross receipts on its most recent US federal tax return [3].
FDA fees are only part of the budget. The real cost drivers are:
- Testing. Its scope depends on your device type and predicate.
- Repeat work. Tests to the wrong standard version, or a weak response to FDA's questions, add cost and time.
- US roles. You will pay a US Agent, and you may pay an advisor.
Use our FDA user fees page to check the current rates before you budget.
How long does FDA clearance take for Indian manufacturers?
Indian Traditional 510(k)s cleared from January 2023 to September 2026 took a median of 207 days from FDA's receipt to clearance. A quarter cleared within 133 days, and a quarter took 268 days or more. Only 14% cleared within 90 days [1]. The median for all applicants was 151 days.
The device mix explains only part of the gap. Compared with the median for the same device types, Indian 510(k)s took about 21% longer [1]. Our review times by country analysis has the full method.
India's numbers per device type are small, so treat this table as a signal, not a forecast [1]:
| Device type (product code) | Indian 510(k)s | Indian median (days) | All applicants median (days) |
|---|---|---|---|
| Soft tissue fixation fasteners (MBI) | 5 | 85 | 94 |
| Radiological image processing systems (LLZ) | 4 | 216 | 157 |
| Pedicle screw systems (NKB) | 4 | 335 | 88 |
The all-applicant figures include the Indian clearances. Look up recent clearances for your own product code in FDA's 510(k) database to see your device's range.
FDA's review goal counts only FDA's own days. Its clock stops while it waits for your answers, and it starts only once FDA accepts the file [7]. So much of a long total is time on hold. That puts the fastest lever in your hands: a complete eSTAR and quick, complete answers to FDA's questions.
Faster routes exist but India rarely used them. Only 5 Indian clearances were Special 510(k)s, which are for changes to your own cleared device. Only 4 used third-party review [1]. Check whether your device type is eligible, using our third-party review guide.
When do you need a US Agent and FDA registration?
Not before your 510(k). You can submit a 510(k) and receive clearance before you register. But no device may be imported into the US unless its maker's site is registered and the device is listed [4].
The rules for an Indian site [4]:
- Timing. Register within 30 days of starting the operation that requires registration, and list your devices at the same time.
- Fee first. Pay the annual registration fee before you register. A site is not legally registered until it has registered and paid [3].
- One US Agent. Name one US Agent who lives or has a place of business in the US. FDA may contact the agent when it cannot reach you, and the agent helps schedule inspections. Report any change to the agent within 10 business days.
- Every year. Renew registration and review all listings between October 1 and December 31.
- English. Registration and listing information must be in English.
X-ray and laser devices have extra rules. Eight Indian clearances were X-ray equipment or lasers [1]. These are also radiation-emitting electronic products. X-ray systems and many laser products need a radiation safety product report, which must reach FDA before the product enters commerce [4]. A maker of electronic products must also name a permanent US resident, a person or a company, as its agent for legal notices before offering a product for import. This is a separate designation from the US Agent in your registration [4].
Complizen's US team handles establishment registration, device listing and the US Agent role for foreign manufacturers. Exempt devices can enter the US this way while a 510(k) for another device is still in progress.
Which Indian test reports does FDA accept?
FDA accepts test reports from Indian labs. What counts is the standard and version you tested to, the completeness of the report and how the study was run, not where the lab is.
Three points matter most for Indian manufacturers:
- No ASCA labs in India yet. On October 12, 2026, FDA's ASCA program listed 98 accredited labs, and none were in India [10]. For biocompatibility, an ASCA summary report can replace a complete test report in some cases [12]. Without an ASCA lab, plan to submit complete biocompatibility test reports [12].
- Lab accreditation is not GLP. For biocompatibility, FDA recommends complete test reports and a statement that the studies followed its Good Laboratory Practice rules in 21 CFR Part 58 [12]. ISO/IEC 17025 accreditation, from NABL or any other body, does not answer that. FDA notes it does not recognize ISO/IEC 17025 for this purpose [12].
- The standard version. FDA recognizes specific versions of each standard. Check the version before testing starts, not after.
Our guide to using foreign test reports in a 510(k) covers the full rules.
What do Indian manufacturers get wrong?
Each of these mistakes breaks a clear FDA rule:
| Common mistake | What FDA actually requires |
|---|---|
| Sending the CDSCO dossier as the 510(k) | A comparison to a US predicate, in the eSTAR format, in English [4, 5, 6] |
| Mapping the CDSCO class to an FDA class | A fresh check of the FDA product code and regulation [11] |
| Choosing a predicate sold only in India | A predicate legally marketed in the US [4] |
| Paying the full 510(k) fee by mistake | A small business request, with an Income Tax Department certification, at least 60 days before the fee is due [3] |
| Assuming every Class I device is exempt | A check of each product code: surgeon's gloves are Class I and need a 510(k) [11] |
| Treating NABL accreditation as GLP | A GLP statement for biocompatibility studies [12] |
| Answering an FDA question late or in part | A complete response within 180 calendar days, or the 510(k) is withdrawn [7] |
What should you do next?
Start with your product code. It tells you whether you need a 510(k), which standards apply and how long similar devices have taken. Then compare your CDSCO dossier with what a 510(k) for that product code needs. Before you submit, decide who will answer FDA's questions, and how fast. Holds are where much of the time goes.
If you want a second view of that comparison, Complizen's free Gap Assessment checks your device documents against what a 510(k) needs before you file. For the wider picture of selling in the US from outside it, see our international path.
Frequently asked questions
How does an Indian manufacturer get FDA approval?
Most devices from India need 510(k) clearance, not approval. You show that your device is substantially equivalent to a predicate legally marketed in the US. Some devices are exempt from a 510(k). Every device also needs FDA establishment registration, device listing and a US Agent before it is imported.
Does a CDSCO licence speed up FDA clearance?
No. FDA does not accept a CDSCO licence in place of a 510(k), and it does not shorten FDA's review. What can carry over is the evidence behind the licence, such as test reports to FDA-recognized standards and an ISO 13485 quality system. FDA judges that evidence on its own terms.
How many Indian medical devices has FDA cleared?
FDA cleared 84 510(k)s from applicants in India from January 2023 to September 2026, according to our count of FDA's public data. Radiology, orthopedic and general hospital devices led. The yearly count fell from 32 in 2023 to 15 in 2025, with 9 by the end of September 2026.
Do I need a US Agent before submitting a 510(k)?
No. You can submit a 510(k) and receive clearance before naming a US Agent. You must register your site, list the device and name a US Agent before the device is imported into the US. Registration also requires paying the annual registration fee first.
How much does a 510(k) cost an Indian company in FY2027?
FDA's 510(k) fee for fiscal year 2027 is $28,653, or $7,163 for a qualifying small business. Annual establishment registration is $13,785. Testing, a US Agent and any advisor are separate costs. They depend on your device type and how much testing your predicate comparison needs.
How does an Indian company qualify as an FDA small business?
Send FDA a MDUFA Small Business Request form and a certification from India's Income Tax Department. It must show gross receipts in US dollars and rupees, with the exchange rate. Affiliates need certifications too. Combined receipts must be no more than $100 million. Apply at least 60 days before the fee is due.
How long does FDA clearance take for Indian manufacturers?
Indian Traditional 510(k)s cleared from 2023 to September 2026 took a median of 207 days from receipt to clearance. That is about 21% longer than typical for the same device types, and only 14% cleared within 90 days. Much of the time is hold time while FDA waits for answers.
Can I use test reports from an Indian lab?
Yes. FDA accepts reports from Indian labs if they meet its expectations: the FDA-recognized standard version and a complete report. No Indian lab is in FDA's ASCA program yet, so plan for complete reports. Biocompatibility studies also need a statement on Good Laboratory Practice.
Does my Class I device need a 510(k)?
Usually not, but check. Most Class I device types are exempt, yet some are not. Surgeon's gloves are Class I and still need a 510(k). Exemptions also have limits, such as a new intended use. Look up your product code in FDA's classification database before you plan.
Can I use a device sold in India as my predicate?
No. A predicate must be legally marketed in the US. That means a device cleared through a 510(k), marketed before May 28, 1976, or reclassified. You can search FDA's 510(k) database by product code to find predicates that companies with similar devices have used.
Do contract manufacturers in India need to register with FDA?
Yes. A site that makes a device for another company must register with FDA and list the device, even when the other company owns the design. India had 133 sites registered as contract manufacturers in FDA's data. Each registered manufacturing site pays the annual registration fee, which is $13,785 for FY2027.
Does my CDSCO class match my FDA class?
Not necessarily. CDSCO uses four classes, A to D, and FDA uses three. The boundaries differ, so a CDSCO Class B device is not automatically FDA Class II. Find your device's product code and regulation in FDA's classification database, and build your plan from that.
References
- openFDA. 510(k) API, decisions dated January 3, 2023 to September 27, 2026. Accessed October 12, 2026.
- openFDA. Registration and Listing API, establishments in India. Accessed October 13, 2026.
- FDA. Medical Device User Fee Rates for Fiscal Year 2027. Federal Register, July 30, 2026.
- eCFR. Title 21: Part 807, Establishment Registration and Device Listing (§§ 807.20, 807.22, 807.40, 807.81, 807.92); § 812.28, Acceptance of clinical data to support medical device applications; § 880.9, Limitations of exemptions; § 1002.10, Product reports; § 1005.25, Service of process on manufacturers. Current as of October 2026.
- FDA. Electronic Submission Template for Medical Device 510(k) Submissions. Final guidance, October 2, 2023.
- FDA. Refuse to Accept Policy for 510(k)s. Final guidance, April 21, 2022.
- FDA. FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals. Final guidance, October 3, 2022.
- FDA. Medical Device Single Audit Program (MDSAP). Content current as of December 19, 2025.
- FDA. Medical Devices; Quality System Regulation Amendments. Final rule, Federal Register, February 2, 2024, effective February 2, 2026.
- FDA. ASCA-Accredited Testing Laboratories database. Accessed October 12, 2026.
- FDA. Product Classification database. Accessed October 13, 2026.
- FDA. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Final guidance, September 8, 2023.