Importing Medical Devices License India
What licence do I need to import medical devices into India?
For commercial import you need an import licence in Form MD-15. The Central Licensing Authority (CDSCO) grants it on an application in Form MD-14, made through the Ministry of Health and Family Welfare's online portal [1][2]. Only an Indian authorised agent can apply: a person or firm the overseas manufacturer has appointed by power of attorney to import into India [3]. That agent must already hold a licence to manufacture for sale or distribution, or a wholesale licence for sale or distribution, under the Rules [1].
Approach: I read Chapter V (Import of Medical Devices) of India's Medical Devices Rules, 2017. The text I have is the original 2017 Gazette version (G.S.R. 78(E)), so amendments made since 2017 are not included below.
Commercial import licence (MD-14 application, MD-15 licence), Rules 34 to 39
- What goes with the application: the fee in the Second Schedule and the documents in the Fourth Schedule. If any document changes before the licence is granted, you must tell CDSCO in writing. Adding a manufacturing site, or another device from the same site, needs a further application with its own fee and documents [1][2].
- Inspection: CDSCO "may" inspect the overseas manufacturing site, and the applicant pays the inspection fee (Rule 35) [2].
- Decision time: within nine months of application. If refused, you can appeal to the Central Government within 45 days (Rule 36(1)-(2)) [2].
- Evidence needed depends on the reference country:
- Free sale certificate from Australia, Canada, Japan, an EU country or the USA: the licence "shall be granted" without a clinical investigation (Rule 36(3)) [2].
- Any other country, Class C or D: an Indian clinical investigation under Chapter VII must establish safety and effectiveness (Rule 36(4)) [2].
- Any other country, Class A or B: you need published safety and performance data or a clinical investigation in the country of origin, plus a free sale certificate from that country (Rule 36(5)) [2].
- Investigational device or new IVD: you need prior permission in Form MD-27 or MD-29 before any import licence can be granted (Rule 36(6)) [2]. Devices with no predicate need a Form MD-26 application after their clinical investigation (Rule 63) [4]. New IVDs use Form MD-28 (Rule 64) [5].
- Validity: the licence lasts indefinitely unless cancelled or surrendered. A retention fee is due every five years for each overseas site and each licensed device. You can pay up to 90 days late with a 2% per month late fee; after that the licence is treated as cancelled (Rule 37) [2].
- Ongoing duties (Rule 38):
- Report any overseas regulatory action, such as a market withdrawal, within 15 days, and stop dispatch of the device [2].
- Get prior approval for major changes and notify minor changes within 30 days (both as defined in the Sixth Schedule) [2].
- Notify a change in constitution of the manufacturer or agent within 30 days [6].
- Send each consignment with an invoice or statement of device name and quantity [6].
- Change in constitution (Rule 39): a fresh MD-14 application is required within 180 days. The existing licence stays valid until the new one is decided. "Licencee" here includes the overseas manufacturer who signed the power of attorney [6].
Other import routes (not for commercial supply)
| Purpose | Apply in | Granted in | Key terms |
|---|---|---|---|
| Clinical investigation, test, evaluation, demonstration, training (Rules 40-41) | MD-16 | MD-17 test licence | Decided within 30 days; valid 3 years; use only at the place named in the licence; unused devices may be exported or destroyed under intimation to CDSCO [6] |
| Investigational device, approved in its country of origin, for treating a patient at a Government hospital or statutory medical institution (Rule 42) | MD-18 | MD-19 | For life-threatening disease, serious permanent disability or unmet need; device used only for that patient [6][7] |
| Personal use, not in personal baggage (Rule 43(2)-(3)) | MD-20 | MD-21 permission | Needs a prescription from a registered medical practitioner; decided within 7 days. No licence is needed for small prescribed quantities carried as personal baggage (Rule 43(1)) [7] |
If you tell me the device and its risk class, I can check whether it is on CDSCO's list of approved devices or the risk classification list.
Which licences cover manufacturing in India?
Which manufacturing licence you need depends on the device's risk class. Class A and B licences are issued by the State Licensing Authority (Form MD-5 licence or Form MD-6 loan licence, applied for in MD-3 or MD-4) [8][9]. Class C and D licences are issued by the Central Licensing Authority (Form MD-9 licence or Form MD-10 loan licence, applied for in MD-7 or MD-8) [9][10]. If you are making small quantities for clinical investigation, testing, evaluation, demonstration or training, a separate test licence (Form MD-13) covers that [1].
Approach: I read Chapter IV (Manufacture of Medical Devices for Sale or for Distribution) of India's Medical Devices Rules, 2017. This is the original 2017 Gazette text (G.S.R. 78(E)), so amendments made since then are not included.
Licences by class
| Class A | Class B | Class C / D | |
|---|---|---|---|
| Authority | State Licensing Authority | State Licensing Authority | Central Licensing Authority (CDSCO) |
| Apply in | MD-3 (licence) / MD-4 (loan licence), on the Ministry of Health and Family Welfare online portal | Same as Class A | MD-7 (licence) / MD-8 (loan licence), online portal |
| Granted in | MD-5 / MD-6 | MD-5 / MD-6 | MD-9 / MD-10 |
| Site check before grant | No audit before grant. A Notified Body audit must follow within 120 days of the grant | Notified Body audit within 90 days of application. Report due to the State authority within 30 days of the audit | Inspection within 60 days of application, by at least two Medical Device Officers or a Notified Body |
| Decision time | 45 days from application | 20 days from receipt of the audit report | Document scrutiny within 45 days; decision within 45 days of receiving the inspection report |
| Appeal | State Government, within 45 days | State Government, within 45 days | Central Government, within 45 days |
Sources for the table: [8][9][10]
On loan licences: no site inspection is needed for a Class C/D loan licence if the site already holds a licence to manufacture that device for sale or distribution (Rule 23(1) proviso) [10].
What every applicant must have (Rules 20(2)-(3), 21(2), 22)
- Fee and documents: the fee in the Second Schedule and the documents in Part II of the Fourth Schedule. Class A/B applications also need an undertaking that the Fifth Schedule Quality Management System requirements are met [8][9].
- Quality system: the site must comply with the Fifth Schedule QMS [10].
- Technical staff:
- Manufacturing supervisor: a degree in a relevant branch of engineering, pharmacy or science plus at least 2 years in manufacturing or testing of medical devices; or a diploma in engineering or pharmacy plus at least 4 years.
- Testing supervisor: a degree or diploma in a relevant subject plus at least 2 years in testing of medical devices [10].
- Investigational device or new IVD: you must get prior permission in Form MD-27 or MD-29 from the Central Licensing Authority. No manufacturing licence for any class of such device is granted without it (Rule 25(4)) [10].
- Adding devices at a licensed site: you need a further application for permission, with its own fee and documents (Rule 25(3)) [10].
Conditions after grant (Rule 26, applies to MD-5, MD-6, MD-9 and MD-10)
- Adverse events: report any suspected unexpected serious adverse event, and the action taken including any recall, within 15 days [10].
- Changes (as defined in the Sixth Schedule):
- Batch control: test every batch before release, in your own laboratory or one registered under Rule 83(3). For invasive devices and IVDs, keep at least one sample unit from each batch for 180 days after the batch expires [11].
- Records: keep an audit/inspection book in Form MD-11, and keep manufacturing and sales records open to inspection [11].
- Non-conforming lots: when directed, withdraw the rest of the lot from sale and recall it as far as practicable [11].
- Supply and supervision: devices offered for sale must come with a package insert or user manual where applicable. Manufacturing and testing must be done only under the competent technical staff [11].
- Stoppages: tell the authority if manufacturing stops, or the site closes, for 30 days or more [11].
Validity, oversight and change of ownership (Rules 27-30)
- Validity: licences "shall remain valid in perpetuity", provided the retention fee is paid before each five-year period ends. A late fee of 2% per month applies for up to 180 days. After that, the licence is deemed cancelled [11].
- Change in constitution: tell the authority within 45 days, and make a fresh application within 180 days. The existing licence stays valid until the new one is decided [11].
- Unannounced inspections (Class A/B): the State authority "shall" carry out random inspections. These must number at least 2% of the Notified Body audits in that State for that class [11].
- For-cause inspections: the State authority (Class A/B) or the Central authority (any class) may also order an inspection if it suspects non-conformity (Rule 20(8)) [9].
- Suspension and cancellation: follow a show-cause notice. You can appeal within 45 days [11].
Test licence (Rules 31-33)
- Application: Form MD-12 to the Central Licensing Authority, with the fee and:
- a device description and an undertaking on facilities;
- lists of equipment and qualified personnel;
- any existing manufacturing licence and any Government R&D approval.
- Grant: decided within 30 days, granted in Form MD-13, valid for 3 years [1].
- Conditions: use the devices only for the stated purpose at the place named in the licence. Allow Medical Device Officers to enter with or without notice. Keep records of the quantities made, tested and stocked, and what happened to them [1].
If you give me the device, I can check CDSCO's list of approved devices for existing manufacturing licences for it.