CDSCO · structured requirements

🇮🇳 India medical device regulatory data

Explore the medical device requirements currently available for India, organized by topic and linked to official sources.

48 facts22 dimensions13 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

Compare countries

Definitions used by the Drugs and Magic Remedies Act

advertising.dmra-scope

Fact-level verified

Under the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954, 'advertisement' includes any notice, circular, label, wrapper or other document and any announcement made orally or by means of producing or transmitting light, sound or smoke. The Act's definition of 'drug' includes substances intended for diagnosis, cure, mitigation, treatment or prevention of disease and articles, other than food, intended to affect the structure or any organic function of the body.

Misleading drug advertisements

advertising.misleading-claims

Fact-level verified

An advertisement relating to a drug is prohibited if it directly or indirectly gives a false impression regarding the drug's true character, makes a false claim, or is otherwise false or misleading in a material particular.

Penalty for contravention

advertising.penalty

Fact-level verified

A first conviction may be punished by imprisonment for up to six months, a fine, or both; a subsequent conviction may be punished by imprisonment for up to one year, a fine, or both.

Prohibited disease and condition claims

advertising.prohibited-claims

Fact-level verified

No person may take part in publishing an advertisement referring to a drug in terms calculated to lead to its use for the diagnosis, cure, mitigation, treatment or prevention of a disease, disorder or condition specified in the Schedule or specified by rules under the Act.

Savings and exemptions

advertising.savings-exemptions

Fact-level verified

The Act does not apply to an advertisement sent confidentially, in the prescribed manner, only to a registered medical practitioner. The Central Government may also exempt a specified drug or class of drugs from all or specified provisions of the Act subject to stated conditions.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

Compare countries

Perpetual licence validity

authorization.duration

Fact-level verified

Manufacturing licences (Forms MD-5/MD-6/MD-9/MD-10) remain valid in perpetuity subject to payment of the licence retention fee before completion of every five-year period, unless suspended or cancelled; import licences (MD-15) are likewise perpetual unless cancelled or surrendered, with retention fee per overseas site and per licensed device every five years.

Conditions

Retention fee per Second Schedule.
Manufacture: rule 29(1); import: rule 37.

Effective from 2018-01-01

Lapse on non-payment

authorization.lapse

Fact-level verified

If the retention fee is not paid within the permitted late-fee period, the licence is deemed to have been cancelled (and a fresh licence is then required).

Conditions

Manufacture licences: rule 29(2); import licences: rule 37 second proviso; MD-42 sale registration: rule 87C(1).

Effective from 2018-01-01

Retention fee and late-payment grace

authorization.renewal

Fact-level verified

Retention fee is payable every five years. The late-payment grace differs by authorisation type: import licences - deposit permitted up to 90 days after the due date with late fee of 2% per mensem (rule 37 proviso); manufacturing licences - up to 180 days with late fee of 2% per month (rule 29(2)); Form MD-42 sale registration - up to six months with late fee of 2% per month (rule 87C).

Conditions

Corrects the blanket 'late period up to 90 days' previously recorded: 90 days applies to import licences only.

Effective from 2018-01-01

Authority & regime

Which authority and binding regime govern this product, task, and date?

Compare countries

Competent authority

authority.competent-authority

Fact-level verified

CDSCO is the Central Licensing Authority (CLA) for import of all device classes, manufacture of Class C and Class D, clinical investigation of investigational devices, and clinical performance evaluation of new IVDs; State Drugs Controllers are State Licensing Authorities for manufacture of Class A/B and for sale of all classes.

Conditions

Central level: CDSCO (rule 8(1)); State level: State Drugs Controller (rule 8(2)).
Applies to devices regulated under the Medical Devices Rules, 2017.

Effective from 2018-01-01

Rule 8(2): 'The State Drugs Controller, by whatever name called, shall be the State Licensing Authority...' competent for '(i) manufacture for sale or distribution of Class A or Class B medical devices; (ii) sale, stock, exhibit or offer for sale or distribution of medical devices of all classes.'

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

Compare countries

Change-control outcomes

change.available-outcomes

Fact-level verified

Outcomes are: notification (minor changes, within 30 days), prior approval with deemed-approval on authority silence (major changes), or a fresh licence application (change in constitution of the licensee, within 180 days).

Conditions

Manufacture: rules 26(iii)-(iv); import: rules 38(v)-(vii); constitution: rules 27 and 39.

Effective from 2018-01-01

Major change prior approval and clocks

change.major-approval

Fact-level verified

Major changes listed in the Sixth Schedule (construction material; design affecting quality, indications, performance or stability; intended use; sterilisation method; approved shelf life; name/address of manufacturer or authorised agent; label; manufacturing process; primary packaging) require prior approval before implementation: CLA/SLA decision within 45 days for manufacture licences (deemed approved on silence); within 60 days for import licences (deemed approved on silence). Minor changes are informed within 30 days of taking effect.

Conditions

Sixth Schedule Part (A) = major; Part (B) = minor (design/process not affecting quality, packaging specifications other than primary packaging).

Effective from 2018-01-01

Rule 26(iii): approval or rejection 'within forty five days and in case where no communication is received within the stipulated time ... deemed to have been approved'; rule 38(v)-(vi): 'within sixty days' for import licences.

Fresh application triggers

change.new-application-triggers

Fact-level verified

A change in constitution of the licensee (including the overseas manufacturer that executed the power of attorney) triggers a fresh licence application within 180 days of the change; the existing licence remains valid until the fresh licence is issued or the application is rejected.

Conditions

Rule 39 (import); rule 27 (manufacture, application within 180 days, existing licence deemed valid).

Effective from 2018-01-01

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

Compare countries

No-predicate device permission

clinical.no-predicate-permission

Fact-level verified

Import or manufacture of a device without a predicate requires prior permission after clinical investigation (application Form MD-26, permission Form MD-27, decision within 120 days extendable by 30, fee INR 50,000). The CLA may abbreviate, defer or omit data for life-threatening or special-relevance indications; Class A investigational devices may not need investigation data; and clinical investigation results may be omitted where the device is approved in the UK, USA, Australia, Canada or Japan, has been marketed there at least two years, no Indian-population difference is expected, and the applicant undertakes post-marketing clinical investigation.

Conditions

Rule 63(1) provisos; two-year marketing plus safety/pharmacovigilance data satisfaction required.

Effective from 2018-01-01

Clinical investigation permission

clinical.permission-required

Fact-level verified

No sponsor may conduct a clinical investigation of an investigational device in human participants except under CLA permission (application Form MD-22 with Seventh Schedule data; permission Form MD-23; decision within 90 days per rule 52(ii)); academic clinical studies on licensed devices need no permission where the Ethics Committee approves and the data will not be used for a marketing application.

Conditions

Academic exemption conditions in rule 51(3)(a)-(b).

Effective from 2018-01-01

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

Compare countries

All-device definition

device.definition-all-devices

Fact-level verified

Since 1 April 2020 every device - instrument, apparatus, appliance, implant, material or other article, used alone or in combination, including software or an accessory, not achieving its primary intended action by pharmacological, immunological or metabolic means - is regulated as a drug for the listed purposes (diagnosis/prevention/monitoring/treatment/alleviation of disease or disorder; injury or disability; investigation/replacement/modification/support of anatomy or physiological process; supporting or sustaining life; disinfection of medical devices; control of conception).

Conditions

Effective from 01.04.2020 under S.O. 648(E), issued under s.3(b)(iv) of the Drugs and Cosmetics Act, 1940.

Effective from 2020-04-01

Devices regulated as drugs

device.drug-status

Fact-level verified

Medical devices are regulated as 'drugs' under s.3(b)(iv) of the Drugs and Cosmetics Act, 1940: devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease become drugs when notified by the Central Government in the Official Gazette.

Conditions

Central Government notifies device categories from time to time (all devices notified w.e.f. 01.04.2020 by S.O. 648(E)).

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

Compare countries

Import dossier evidence

dossier.import-evidence

Fact-level verified

Import licence applications require: notarised overseas plant registration and free sale certificate from the country of origin; notarised QMS certificate (or Full/Production Quality Assurance certificate); self-attested Indian wholesale or manufacturing licence; and a copy of the latest inspection/audit report by a notified body or authority within the last three years.

Conditions

Documents per Fourth Schedule Part II paragraph (i)(b), clauses (A)-(D).
Class B/C/D dossiers additionally include site/plant master file, device master file and essential principles checklist.

Effective from 2018-01-01

Power of attorney legalisation

dossier.power-of-attorney-authentication

Fact-level verified

The overseas manufacturer's power of attorney in favour of the Indian authorised agent must be authenticated in India either by a first-class Magistrate, or by the Indian Embassy in the country of origin, or by an equivalent authority through apostille.

Conditions

Applies to the power of attorney submitted with licence applications (Fourth Schedule Part I).

Effective from 2018-01-01

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

Compare countries

Indian authorised agent requirement

market-entry.local-role

Fact-level verified

A foreign manufacturer must appoint an Indian authorised agent - a person, firm or organisation appointed through a power of attorney - to undertake import of the device in India; the agent holds the import licence and must itself hold a manufacture/wholesale licence or an MD-42 sale registration.

Conditions

Required for all import licence applications (rule 34(1)).
Power of attorney authentication per Fourth Schedule Part I.

Effective from 2018-01-01

Change of authorised agent

market-entry.representative-change

Fact-level verified

Changing the name or address of the overseas manufacturer or the authorised agent is a major change under the Sixth Schedule requiring prior CLA approval before taking effect; a change in constitution of the licensee requires a fresh application within 180 days, with the existing licence deemed valid until decision.

Conditions

Import licences: rule 38(v)-(vi) prior approval (approval/rejection within sixty days, deemed approved on silence); constitution changes informed within 30 days (rule 38(viii)).

Effective from 2018-01-01

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

Compare countries

Sale registration certificate (Form MD-42)

establishment.sale-registration

Fact-level verified

Any person selling, stocking, exhibiting or offering for sale or distributing devices must obtain a registration certificate: application in Form MD-41 to the State Licensing Authority, granted as Form MD-42 within ten days, subject to a self-certificate of Good Distribution Compliance; the certificate is perpetual subject to five-yearly retention fee (late grace up to six months at 2% per month).

Conditions

Devices purchased only from importer, licensed manufacturer or registered/licensed entity (rule 87B(4)).
Records kept at least two years (rule 87B(7)).
Inserted by G.S.R. 754(E) w.e.f. 30.09.2022; rule 34(1) amended to accept MD-42 holders as import applicants.

Effective from 2022-09-30

Rule 87A(4): grant or rejection 'within ten days from the date the application is made'; rule 87C(1): 'shall remain valid in perpetuity, subject to payment of registration certificate retention fee ... before completion of the period of five years'.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

Compare countries

Electronic instructions for use

label.electronic-ifu

Fact-level verified

Electronic instructions for use are expressly recognised: G.S.R. 30(E) inserted 'or electronic instructions for use' into rule 3(v), rule 59(3)(iii) and the Fourth and Seventh Schedules.

Conditions

Amendment came into force on publication, 15 January 2019.

Effective from 2019-01-15

Label particulars and symbols

label.particulars

Fact-level verified

Labels must bear the device name, net quantity, month/year of manufacture and expiry (or shelf life), lot/batch number, storage conditions, sterile state and sterilisation method, single-use indication where relevant, and warnings; imported devices add, by stickering where not printed, the import licence number, importer name and address, manufacturing premises address and date of manufacture; BIS or ISO symbols may replace text.

Conditions

Full list in rule 44(1) clauses (a)-(o); symbol proviso requires the meaning to be obvious or safety not compromised.

Effective from 2018-01-01

Shelf life and residual shelf life on import

label.shelf-life-import

Fact-level verified

Shelf life ordinarily must not exceed sixty months from manufacture; imported devices must retain at least 40% residual shelf life (claims under 90 days), 50% (claims of 90 days to one year) or 60% (claims over one year) at the date of import.

Conditions

Longer shelf life possible with satisfactory evidence accepted by the CLA (rule 47 opening).

Effective from 2018-01-01

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

Compare countries

Chapter IIIA registration of all notified devices and transition

legal-basis.ch3a-registration-transition

Fact-level verified

From 1 April 2020 all devices notified under s.3(b) of the Act must be registered with the CLA on the Online System for Medical Devices (registration voluntary for 18 months, then mandatory); the exemption of registered devices from full licensing ends 30 months after notification for Class A/B and 42 months for Class C/D.

Conditions

Devices specified in the Annexure to the Eighth Schedule are outside Chapter IIIA.
Voluntary period: 18 months from 01.04.2020; exemption ceases after 30 months (Class A/B) and 42 months (Class C/D) from 11.02.2020 notification.

Effective from 2020-04-01

Eighth Schedule entry 7: 'such exemption shall cease after a period of thirty months for low risk - Class A and low moderate risk - Class B and after a period of forty-two months for moderate high risk - Class C and high risk - Class D devices'.

Primary rules and commencement

legal-basis.mdr2017

Fact-level verified

Medical Devices Rules, 2017 (notified as G.S.R. 78(E) dated 31 January 2017) under the Drugs and Cosmetics Act, 1940 govern medical devices and IVDs; the rules came into force on 1 January 2018.

Conditions

Applies to substances used for in vitro diagnosis, notified devices, and devices notified under s.3(b)(iv) of the Act (rule 2).

Effective from 2018-01-01

MDR 2017 = Medical Devices Rules, 2017 (G.S.R. 78(E)).

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

Compare countries

Periodic Safety Update Reports

pms.psur-md27

Fact-level verified

Holders of Form MD-27 no-predicate permission must submit Periodic Safety Update Reports to the CLA from the date of market launch: every six months for the first two years, then annually for two further years, and must inform the CLA of the launch date; Fifth Schedule 8.5.1 additionally requires documented advisory-notice procedures, complaint-investigation records and adverse-event notification to the authority.

Conditions

Rule 65(b) and (c); Fifth Schedule 8.5.1 for all manufacturers.

Effective from 2018-01-01

Official forms & portals

Which current form, portal, account, and submission package must be used?

Compare countries

Import application form and portal

forms.sugam-import

Fact-level verified

Import licence applications are made in Form MD-14 on the SUGAM online portal, with the licence issued as Form MD-15; state-side applications use the Ministry's identified online portal.

Conditions

Statement on CDSCO's official Medical Device & Diagnostics page.

Rule 34(1): application 'through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14'.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

Compare countries

QMS evidence for market access

qms.market-access-evidence

Fact-level verified

The Fifth Schedule QMS (design, manufacture, packaging, labelling, testing, installation, servicing) applies to manufacturers; for import and Chapter IIIA registration a notarised ISO 13485 certificate is the market-access evidence, while domestic manufacture remains subject to the Fifth Schedule, Notified Body audits and licensing-authority inspection.

Conditions

Manufacture licence applications include an undertaking of Fifth Schedule compliance (rule 20(3)).
Class B sites audited by a Notified Body before grant (rule 20(5)-(6)).

Effective from 2018-01-01

Notified Body audit timing

qms.notified-body-audit

Fact-level verified

For Class A manufacture no site audit is required before grant; the registered Notified Body must audit within 120 days after grant. For Class B the Notified Body audit precedes grant: audit within 90 days of application, report to the SLA within 30 days of audit, SLA decision within 20 days of the report.

Conditions

Class A proviso and Class B sub-rule 6 apply to manufacture licences under rule 20.
CLA may use Notified Bodies or experts for Class C/D inspections (rules 21(3)-(6)).

Effective from 2018-01-01

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

Compare countries

Recall duty and authority directions

recall.manufacturer-duty

Fact-level verified

A manufacturer or authorised agent who has reason to believe a placed device may be unsafe must immediately initiate procedures to withdraw it from the market and patients, indicate the reasons and inform the competent authority; where the CLA is satisfied a device does not conform, it may direct that the entire batch (or more than one or all batches) not be sold or be recalled, including from hospitals where stocked.

Conditions

Rule 89(1)-(3); rule 38(2) with proviso on multiple batches; manufacture lot-withdrawal duty in rule 26(vi).

Effective from 2018-01-01

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

Class A non-sterile non-measuring registration route

registration.classa-nsnm-registration

Fact-level verified

Class A devices that are non-sterile and non-measuring are exempt from the licensing regime: manufacturer and importer register them on the Online System for Medical Devices with self-certification (essential principles checklist, standards) and, for importers, a plant registration or free sale certificate.

Conditions

Applies only to Class A non-sterile and non-measuring devices per First Schedule.
Chapter IIIB inserted by G.S.R. 777(E) w.e.f. 14.10.2022.

Effective from 2022-10-14

All-device licensing regime start dates

registration.licensing-regime-dates

Fact-level verified

CDSCO notices fix the start of the licensing regime for all Class A and B devices at 1 October 2022 and for all Class C and D devices at 1 October 2023, following the G.S.R. 102(E) registration transition.

Conditions

Dates stated in CDSCO Medical Device & Diagnostics page notice titles referencing G.S.R. 102(E) dt. 11.02.2020.

Effective from 2022-10-01

Market-access route

registration.market-access-route

Fact-level verified

Route depends on class and origin: Class A/B manufacture licensed by the State Licensing Authority (Forms MD-3/MD-4 to MD-5/MD-6); Class C/D manufacture and import of all classes licensed by the Central Licensing Authority (Forms MD-7/MD-8 to MD-9/MD-10; import MD-14 to MD-15); Class A non-sterile non-measuring devices follow Chapter IIIB registration instead of licences.

Conditions

All imports: CDSCO regardless of class.
Class A/B domestic manufacture: State Licensing Authority.

Effective from 2018-01-01

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

India approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for India (14 records)

IndiaJapan MHLW / PMDA

Prior approval / evidence record

Japan PMDA

Authority: Japan PMDA
Accepted: Yes
Benefit: Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
Timeline Savings: None published — the saving is the clinical investigation, not the clock

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndiaGHTF

Prior approval / evidence record

Class C

class-c

Class Name

Class C

Risk Level

high

Pathway

Registration with clinical data

Official Timeline

Min: 90
Max: 90
Unit: days

Verification Status

official-verified

Official Source

Title: CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
Url: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 12
Max: 18
Unit: months

With Prior Approval

Min: 6
Max: 9
Unit: months

Prior Approval Benefits

GHTF country approval with predicate

Notes

Rules 21(4)/25(1): CDSCO document scrutiny within 45 days (restartable on deficiency rectification), then licence decision within 45 days of the site-inspection report
Clinical data required

Clinical Trial Required

Yes

Local Testing Required

Yes

Gmp Required

Yes

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndiaUS FDA · EU conformity assessment · Australia TGA · Japan MHLW / PMDA · GHTF

Prior approval / evidence record

Class A

class-a

Class Name

Class A

Risk Level

low

Pathway

Registration

Official Timeline

Min: 45
Max: 45
Unit: days

Verification Status

official-verified

Official Source

Title: CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
Url: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 6
Max: 9
Unit: months

With Prior Approval

Min: 3
Max: 5
Unit: months

Prior Approval Benefits

GHTF country approval (FDA, EU, Japan, Australia, UK)

Notes

Licence granted or rejected within 45 days of application (Rule 20(4)); Notified Body audit happens within 120 days after licence grant, not before (Rule 20(4) proviso (ii))
GHTF approval provides significant advantage

Clinical Trial Required

Local Testing Required

Yes

Gmp Required

Yes

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndiaGHTF

Prior approval / evidence record

Class D

class-d

Class Name

Class D

Risk Level

highest

Pathway

Registration with extensive clinical

Official Timeline

Min: 90
Max: 90
Unit: days

Verification Status

official-verified

Official Source

Title: CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
Url: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 15
Max: 24
Unit: months

With Prior Approval

Min: 8
Max: 12
Unit: months

Prior Approval Benefits

GHTF country approval

Notes

Rules 21(4)/25(1): CDSCO document scrutiny within 45 days (restartable on deficiency rectification), then licence decision within 45 days of the site-inspection report
Indian clinical trials may be required

Clinical Trial Required

Yes

Local Testing Required

Yes

Gmp Required

Yes

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndiaUK MHRA

Prior approval / evidence record

UK MHRA

Authority: UK MHRA
Accepted: Yes
Benefit: Named only in the Rule 63(1) proviso, which waives clinical investigation results for a no-predicate device marketed in the UK for at least two years. The UK is not in the Rule 36(3) list.
Timeline Savings: None published

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndiaEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: Yes
Benefit: A free sale certificate from an EU country triggers the same Rule 36(3) waiver of clinical investigation. The EU is not named in the Rule 63(1) proviso, so a no-predicate device still needs the MD-27 route.
Timeline Savings: None published — the saving is the clinical investigation, not the clock

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndiaNMPA

Prior approval / evidence record

BRICS regulators cooperation MoU (NMPA party): no recognition effect

reliance.china-nmpa-bilateral-programme

Pending verification

Statement: CDSCO and China's NMPA are both parties to the BRICS regulators' Memorandum of Understanding (together with ANVISA, the Russian Ministry of Health, Ministry of Industry and Trade and Roszdravnadzor, and SAHPRA), listed by CDSCO as valid until 31 January 2029. The instrument is a cooperation MoU and creates no recognition of NMPA approvals in India.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: india
China Classes In Scope: Not class-specific; regulatory-cooperation instrument only
Edge Type: Cooperation Mou
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Multilateral (BRICS), not a bilateral India-China device MoU
Cooperation/information-exchange instrument; no legal effect on licensing
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Source passage: 04 BRAZIL, RUSSIA, INDIA, CHINA, SOUTH AFRICA (BRICS) Memorandum of Understanding (MoU) ... The Central Drugs Standard Control Organization of The Republic of INDIA (CDSCO) ... The National Medical Products Administration of The People's Republic of CHINA (NMPA) ... 31.01.2029

IndiaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: A free sale certificate from the United States triggers Rule 36(3): the import licence is granted without clinical investigation. Rule 63(1) fourth proviso additionally waives clinical investigation results for a device without a predicate if it has been US-approved and marketed there for at least two years. Neither provision shortens the nine-month Rule 36(1) decision period.
Timeline Savings: None published — the saving is the clinical investigation, not the clock

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA

Regulatory reference

Free sale certificate reliance for import

reliance.fsc-import

Fact-level verified

Where a free sale certificate has been issued by the national regulatory authority of Australia, Canada, Japan, an EU country, the United Kingdom or the United States, the import licence is granted without carrying out clinical investigation.

Conditions

United Kingdom added to the rule 36(3) list by G.S.R. 174(E) w.e.f. 04.03.2022.
Devices from other countries: Class C/D need Indian clinical investigation (rule 36(4)); Class A/B need published safety/performance data or country-of-origin investigation plus FSC (rule 36(5)).

Effective from 2018-01-01

G.S.R. 174(E): for the words 'or the United States of America' the words 'United Kingdom or the United States of America' shall be substituted.

IndiaAustralia TGA

Prior approval / evidence record

Australia TGA

Authority: Australia TGA
Accepted: Yes
Benefit: Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
Timeline Savings: None published — the saving is the clinical investigation, not the clock

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndiaNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

Statement: For devices imported from countries outside the rule 36(3) list, Class C and D licences may be granted only after safety and effectiveness are established through clinical investigation in India, and Class A and B licences after published safety and performance data or a clinical investigation in the country of origin plus a free sale certificate from the country of origin. A China NMPA registration certificate or the NMPA-based free sale certificate therefore serves only as the country-of-origin documentary evidence required with Form MD-14/MD-15; it gives no abridged review.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: india
China Classes In Scope: NMPA Class II/III certificate or Class I filing used as country-of-origin evidence; Indian Class A/B (rule 36(5)) and Class C/D (rule 36(4))
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Class C/D: clinical investigation in India under Chapter VII (rule 36(4))
Class A/B: published safety/performance data or clinical investigation in the country of origin, and a free sale certificate from the country of origin (rule 36(5))
Import application must also include notarized copy of overseas manufacturing site registration in the country of origin and the Free Sale Certificate 'issued by the National Regulatory Authority or equivalent competent authority of the country concerned as referred under rule 36'
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2018-01-01

Source passage: (4) Where a medical device is imported from countries other than those referred to in sub-rule (3), the licence in case of Class C and Class D medical devices may be granted after its safety and effectiveness has been established through clinical investigation in India as specified under provisions of Chapter VII of these rules. (5) Where a medical device, is imported from countries other than those referred to in sub-rule (3), the licence in case of Class A or Class B medical devices may be granted after its safety and performance has been established through published safety and performance data or through clinical investigation in the country of origin and a free sale certificate from the country of origin is furnished.

IndiaGHTF

Prior approval / evidence record

Class B

class-b

Class Name

Class B

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 45
Max: 140
Unit: days

Verification Status

official-verified

Official Source

Title: CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
Url: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 8
Max: 12
Unit: months

With Prior Approval

Min: 4
Max: 7
Unit: months

Prior Approval Benefits

GHTF country approval

Notes

Rule 20(6) chain: Notified Body audit within 90 days of application, NB report to the licensing authority within 30 days of the audit, licence decision within 20 days of the audit report (140 days total)
Licence grant-or-reject clock is 45 days where it applies (Rule 20(4))
NABL testing may be required

Clinical Trial Required

Local Testing Required

Yes

Gmp Required

Yes

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndiaHealth Canada

Prior approval / evidence record

Health Canada

Authority: Health Canada
Accepted: Yes
Benefit: Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
Timeline Savings: None published — the saving is the clinical investigation, not the clock

CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndiaNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference

Pending verification

Statement: Rule 36(3) of the Medical Devices Rules, 2017 grants the import licence without an Indian clinical investigation only where a free sale certificate has been issued by the national regulatory authority of Australia, Canada, Japan, an EU country or the United States (the United Kingdom was added by amendment in 2022). China/NMPA is not on the list, so an NMPA registration certificate does not trigger the clinical-investigation waiver.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: india
China Classes In Scope: All NMPA classes; concerns Indian import licence (Form MD-15) for Class A-D devices
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

List is exhaustive: Australia, Canada, Japan, European Union countries, United States of America (plus United Kingdom by the 2022 amendment, not reflected in the consolidated CDSCO text quoted)
Devices from other countries fall under rule 36(4) (Class C/D) or 36(5) (Class A/B)
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2018-01-01

Source passage: (3) Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, or the United States of America, a licence shall be granted under sub-rule (1) to the applicant without carrying out clinical investigation.

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Deficiency response deadline

review.deficiency-response-no-predicate

Fact-level verified

Where the CLA intimates inadequate information on a no-predicate (Form MD-26) application, the applicant must furnish the required information within ninety days of the intimation or the application may be rejected; the same ninety-day response rule applies to new IVD (Form MD-28) applications under rule 64(2).

Conditions

Rule 63(2) second proviso; rule 64(2) second proviso (new IVD).

Effective from 2018-01-01

Stop-clock on rectifiable deficiencies

review.stop-clock-cd-manufacture

Fact-level verified

For Class C/D manufacture applications, where the CLA points out rectifiable deficiencies within the stipulated period, the 45-day scrutiny period under rule 21(4) runs from the date the deficiencies are removed.

Conditions

Distinct stop-clock rule supplementing the registration-timelines dataset.

Effective from 2018-01-01

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Custom-made device exemption

special.custom-made

Fact-level verified

Custom-made devices are exempt from the licensing chapters (IV and V) where made to a duly qualified medical practitioner's written prescription, under his responsibility, for the sole use of a particular patient, and labelled 'custom made device'; mass-produced devices merely adapted to user requirements are excluded.

Conditions

Eighth Schedule S.No. 1 read with rule 90; Explanation excludes adaptable mass-produced devices.

Effective from 2018-01-01

Government hospital import of investigational devices

special.govt-hospital-import

Fact-level verified

Small quantities of investigational devices not otherwise importable but approved in the country of origin may be imported for treatment of a patient with a life-threatening disease, disease causing serious permanent disability, or unmet medical need: application in Form MD-18 by a medical officer through the medical superintendent of a Government hospital or statutory medical institution; licence in Form MD-19; fee INR 500 per device.

Conditions

Use exclusively for the named patient; records of import/use maintained (rule 42(4)).

Effective from 2018-01-01

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Appeal against import refusal

appeal.import-refusal

Fact-level verified

An applicant whose import licence application is rejected may appeal to the Central Government within forty-five days; the Government decides within ninety days of the appeal. Documents found misleading, fake or fabricated lead to summary rejection after opportunity of hearing (rule 92), with possible debarment (rule 93, appeal within thirty days).

Conditions

Rule 36(2) (import); analogous 45-day appeals exist for manufacture refusals (rules 20(7), 25(2)) and 60-day disposal for no-predicate refusals (rule 63(3)).

Effective from 2018-01-01

Appeal against import licence suspension or cancellation

appeal.import-suspension

Fact-level verified

Against a CLA order under rule 43A (suspension, cancellation, stop-import or destruction of an import licence), the aggrieved person may appeal to the Central Government within thirty days of service of the order.

Conditions

Rule 43A inserted by G.S.R. 356(E) w.e.f. 18.05.2022.

Effective from 2022-05-18

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

UDI deferred pending Central Government order

udi.effective-date-pending

Fact-level verified

Rule 46 (as substituted by G.S.R. 918(E) with effect from 31 December 2021) requires every device approved for manufacture or import to bear a unique device identification from a date and in a manner to be specified by Central Government order. The substituted rule does not itself establish a calendar date for UDI marking.

Conditions

Rule as substituted by G.S.R. 918(E); manner of UDI also to be specified in the future order.

Effective from 2021-12-31

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Foreign regulatory action reporting by importers

vigilance.foreign-action-15days

Fact-level verified

Import licence holders must inform the CLA forthwith, and in all circumstances within fifteen days, of any administrative action abroad taken on account of an adverse reaction - market withdrawal, regulatory restrictions, cancellation of authorisation or declaration as not of standard quality - in the country of origin or any market where the device is sold; the authorised agent must then immediately stop despatch and marketing of the device.

Conditions

Rule 38(ii) and (iii); CLA may then direct withdrawal from the Indian market (rule 38(iv)).

Effective from 2018-01-01

Materiovigilance Programme of India

vigilance.mvpi

Fact-level verified

The Materiovigilance Programme of India (MvPI), approved by the Ministry of Health and Family Welfare on 6 July 2015, collects device adverse events: the Indian Pharmacopoeia Commission is the National Coordination Centre since 2018, SCTIMST Thiruvananthapuram is the National Collaboration Centre, and CDSCO is the national regulator; IPC publishes the adverse event reporting forms (licence holders/healthcare professionals, consumers, IVD) and a Field Safety Corrective Action form.

Conditions

Institutional programme; statutory reporting deadlines remain those of MDR 2017 rules 26(ii), 38(ii) and 65(d).

MvPI reporting-forms page (id=597) lists 'Field Safety Corrective Action Form' among official forms.

Suspected unexpected serious adverse event reporting

vigilance.susae-15days

Fact-level verified

Manufacturing licence holders must inform the State or Central Licensing Authority of any suspected unexpected serious adverse event and action taken, including any recall, within fifteen days of the event coming to notice; Form MD-27 permission holders must report such events to the CLA within fifteen days of awareness (rule 65(d)).

Conditions

Rule 26(ii) (manufacture licences); rule 65(d) (no-predicate permission holders).

Effective from 2018-01-01

Related structured datasets

Classification systems · 1 record

Open Risk classes A through D. →

india:medical-device

Jurisdiction Id

india

Domains

medical-device
ivd

Name

Risk classes A through D.

Classes

Id
a
Label
Class A
Normalized Risk Level
low
Id
b
Label
Class B
Normalized Risk Level
medium
Id
c
Label
Class C
Normalized Risk Level
high
Id
d
Label
Class D
Normalized Risk Level
highest

Regulator

CDSCO

Official Domains

cdsco.gov.in

Source Status

official-source-verified

Source Title

Medical Devices Rules 2017, Rule 4 and First Schedule (Parts I-II)

Source Url

https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf

Verified On

2026-08-25

Source Supports

class-axis
classification-rules
ivd-class-axis
ivd-classification-rules

Notes

Rule 4(1): Class A low risk, B low moderate, C moderate high, D high risk per Part I of the First Schedule; Rule 4(2): IVDs classified per Part II.
Rule 4(3): the Central Licensing Authority classifies devices based on intended use and First Schedule parameters (binding classification).
Only Class A devices that are non-sterile and non-measuring take the registration-only route (Sixth Amendment Rules 2022, Chapter IIIB, rule 19G(1)).

Registration pathways, prior approvals and planning · 1 record

Open India registration →

Country

India

Jurisdiction Id

india

Country Code

Flag

🇮🇳

Regulator

Central Drugs Standard Control Organisation

Regulator Abbrev

CDSCO

Region

asia-pacific

Tier

Risk Classification

4-class (A, B, C, D)

Classes

Id
class-a
Class Name
Class A
Risk Level
low
Pathway
Registration
Official Timeline
Min
45
Max
45
Unit
days
Verification Status
official-verified
Official Source
Title
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
6
Max
9
Unit
months
With Prior Approval
Min
3
Max
5
Unit
months
Prior Approval Benefits
GHTF country approval (FDA, EU, Japan, Australia, UK)
Notes
Licence granted or rejected within 45 days of application (Rule 20(4)); Notified Body audit happens within 120 days after licence grant, not before (Rule 20(4) proviso (ii))
GHTF approval provides significant advantage
Clinical Trial Required
No
Local Testing Required
Yes
Gmp Required
Yes
Id
class-b
Class Name
Class B
Risk Level
medium
Pathway
Registration
Official Timeline
Min
45
Max
140
Unit
days
Verification Status
official-verified
Official Source
Title
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
8
Max
12
Unit
months
With Prior Approval
Min
4
Max
7
Unit
months
Prior Approval Benefits
GHTF country approval
Notes
Rule 20(6) chain: Notified Body audit within 90 days of application, NB report to the licensing authority within 30 days of the audit, licence decision within 20 days of the audit report (140 days total)
Licence grant-or-reject clock is 45 days where it applies (Rule 20(4))
NABL testing may be required
Clinical Trial Required
No
Local Testing Required
Yes
Gmp Required
Yes
Id
class-c
Class Name
Class C
Risk Level
high
Pathway
Registration with clinical data
Official Timeline
Min
90
Max
90
Unit
days
Verification Status
official-verified
Official Source
Title
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
12
Max
18
Unit
months
With Prior Approval
Min
6
Max
9
Unit
months
Prior Approval Benefits
GHTF country approval with predicate
Notes
Rules 21(4)/25(1): CDSCO document scrutiny within 45 days (restartable on deficiency rectification), then licence decision within 45 days of the site-inspection report
Clinical data required
Clinical Trial Required
Yes
Local Testing Required
Yes
Gmp Required
Yes
Id
class-d
Class Name
Class D
Risk Level
highest
Pathway
Registration with extensive clinical
Official Timeline
Min
90
Max
90
Unit
days
Verification Status
official-verified
Official Source
Title
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
15
Max
24
Unit
months
With Prior Approval
Min
8
Max
12
Unit
months
Prior Approval Benefits
GHTF country approval
Notes
Rules 21(4)/25(1): CDSCO document scrutiny within 45 days (restartable on deficiency rectification), then licence decision within 45 days of the site-inspection report
Indian clinical trials may be required
Clinical Trial Required
Yes
Local Testing Required
Yes
Gmp Required
Yes

Prior Approvals

Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
A free sale certificate from the United States triggers Rule 36(3): the import licence is granted without clinical investigation. Rule 63(1) fourth proviso additionally waives clinical investigation results for a device without a predicate if it has been US-approved and marketed there for at least two years. Neither provision shortens the nine-month Rule 36(1) decision period.
Timeline Savings
None published — the saving is the clinical investigation, not the clock
Authority
EU CE Mark
Accepted
Yes
Benefit
A free sale certificate from an EU country triggers the same Rule 36(3) waiver of clinical investigation. The EU is not named in the Rule 63(1) proviso, so a no-predicate device still needs the MD-27 route.
Timeline Savings
None published — the saving is the clinical investigation, not the clock
Authority
Japan PMDA
Accepted
Yes
Benefit
Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
Timeline Savings
None published — the saving is the clinical investigation, not the clock
Authority
Australia TGA
Accepted
Yes
Benefit
Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
Timeline Savings
None published — the saving is the clinical investigation, not the clock
Authority
Health Canada
Accepted
Yes
Benefit
Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
Timeline Savings
None published — the saving is the clinical investigation, not the clock
Authority
UK MHRA
Accepted
Yes
Benefit
Named only in the Rule 63(1) proviso, which waives clinical investigation results for a no-predicate device marketed in the UK for at least two years. The UK is not in the Rule 36(3) list.
Timeline Savings
None published

Key Requirements

Indian Authorized Agent (for foreign manufacturers)
Rule 7: the device must meet the applicable Bureau of Indian Standards standard, or an ISO, IEC or pharmacopoeial standard where BIS has not laid one down. This is a conformity obligation in the dossier, not a separate BIS licence, which is only compulsory for the narrow set of products covered by a Quality Control Order.
NABL testing from accredited labs
Import license
Free Sale Certificate from home country
Import licence (Rule 36(1)): CLA grants or rejects within nine months of application; clinical investigation permission within 90 days of the MD-22 application (Rule 52(ii))
No-predicate permission (MD-26) 120 days extendable by 30; new IVD permission (MD-28) 90 days extendable by 30; test licence (MD-16) 30 days; personal-use import (MD-20) 7 days; sale registration (MD-41) 10 days

Local Rep Required

Yes

Local Rep Name

Indian Authorized Agent

Mdsap Accepted

Mdsap Benefit

Not accepted. The relief for foreign approvals runs through the Rule 36(3) free sale certificate list, not through MDSAP.

Registration Validity

Perpetual, not a fixed term. A manufacturing licence or loan licence in Form MD-5, MD-6, MD-9 or MD-10 stays valid indefinitely under Rule 29(1) and an import licence in Form MD-15 under Rule 37, in each case provided the retention fee is paid before every fifth anniversary. Miss it and the licence is deemed cancelled, after a 180-day late window with a 2% monthly surcharge for manufacturing licences and a 90-day window for import licences.

Verification Status

official-verified

Official Sources

Title
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Accessed Date
2026-08-25

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by CDSCO. Appoint a Indian Authorized Agent.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to CDSCO including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
CDSCO reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. CDSCO may issue questions.
Duration
45 days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, CDSCO issues India market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

Open India fees →

Country

India

Jurisdiction Id

india

Country Code

Authority

CDSCO

Low Risk Local

Min: 50
Max: 1000
Currency: USD
Per Product: Yes

High Risk Local

Min: 1500
Max: 3000
Currency: USD
Per Product: Yes

Details

Id
import-licence-class-a-site
Item
Import licence - Class A manufacturing site
Currency
USD
Amount Local
1000
Amount Local Formatted
USD 1,000
Frequency
Per site
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
import-licence-class-a-device
Item
Import licence - Class A device
Currency
USD
Amount Local
50
Amount Local Formatted
USD 50
Frequency
Per distinct device
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
import-licence-class-b-site
Item
Import licence - Class B manufacturing site
Currency
USD
Amount Local
2000
Amount Local Formatted
USD 2,000
Frequency
Per site
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
import-licence-class-b-device
Item
Import licence - Class B device
Currency
USD
Amount Local
1000
Amount Local Formatted
USD 1,000
Frequency
Per distinct device
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
import-licence-class-c-d-site
Item
Import licence - Class C/D manufacturing site
Currency
USD
Amount Local
3000
Amount Local Formatted
USD 3,000
Frequency
Per site
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
import-licence-class-c-d-device
Item
Import licence - Class C/D device
Currency
USD
Amount Local
1500
Amount Local Formatted
USD 1,500
Frequency
Per distinct device
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
import-licence-ivd-class-a-b-site
Item
Import licence - IVD Class A/B manufacturing site
Currency
USD
Amount Local
1000
Amount Local Formatted
USD 1,000
Frequency
Per site
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
import-licence-ivd-class-a-b-device
Item
Import licence - IVD Class A/B device
Currency
USD
Amount Local
10
Amount Local Formatted
USD 10
Frequency
Per distinct device
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
import-licence-ivd-class-c-d-site
Item
Import licence - IVD Class C/D manufacturing site
Currency
USD
Amount Local
3000
Amount Local Formatted
USD 3,000
Frequency
Per site
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
import-licence-ivd-class-c-d-device
Item
Import licence - IVD Class C/D device
Currency
USD
Amount Local
500
Amount Local Formatted
USD 500
Frequency
Per distinct device
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
manufacture-licence-class-a-b-site
Item
Manufacture licence - Class A/B site
Currency
INR
Amount Local
5000
Amount Local Formatted
INR 5,000
Frequency
Per site; retention fee is the same
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
manufacture-licence-class-a-b-device
Item
Manufacture licence - Class A/B device
Currency
INR
Amount Local
500
Amount Local Formatted
INR 500
Frequency
Per distinct device
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
manufacture-licence-class-c-d-site
Item
Manufacture licence - Class C/D site
Currency
INR
Amount Local
50000
Amount Local Formatted
INR 50,000
Frequency
Per site; retention fee is the same
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
manufacture-licence-class-c-d-device
Item
Manufacture licence - Class C/D device
Currency
INR
Amount Local
1000
Amount Local Formatted
INR 1,000
Frequency
Per distinct device
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
overseas-site-inspection
Item
Inspection of an overseas manufacturing site
Currency
USD
Amount Local
6000
Amount Local Formatted
USD 6,000
Frequency
Per inspection
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
pilot-clinical-investigation-permission
Item
Permission to conduct a pilot clinical investigation
Currency
INR
Amount Local
100000
Amount Local Formatted
INR 100,000
Frequency
Per permission
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
pivotal-clinical-investigation-permission
Item
Permission to conduct a pivotal clinical investigation
Currency
INR
Amount Local
100000
Amount Local Formatted
INR 100,000
Frequency
Per permission
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
clinical-performance-evaluation-permission
Item
Permission for clinical performance evaluation
Currency
INR
Amount Local
25000
Amount Local Formatted
INR 25,000
Frequency
Per permission
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
no-predicate-device-permission
Item
Permission to investigate a new device with no predicate
Currency
INR
Amount Local
50000
Amount Local Formatted
INR 50,000
Frequency
Per permission
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
new-ivd-permission
Item
Permission for a new in-vitro diagnostic device
Currency
INR
Amount Local
25000
Amount Local Formatted
INR 25,000
Frequency
Per permission
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25
Id
export-certificate
Item
Export certificate for a medical device
Currency
INR
Amount Local
1000
Amount Local Formatted
INR 1,000
Frequency
Per certificate
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Source Title
India Medical Devices Rules 2017, fee schedule
Verified On
2026-08-25

Notes

Import-licence fees are denominated in USD under the Medical Devices Rules; domestic-manufacture, investigation, and certificate fees are in INR.
Site and per-device fees are cumulative; IVD import fees are lower than the non-IVD schedule (e.g. USD 10 per Class A/B IVD device).
Test/evaluation/demonstration imports cost USD 100 per device; government-hospital patient-treatment imports cost INR 500 per device.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
India Medical Devices Rules 2017, fee schedule
Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

Open India certifications →

Slug

india

Market

India

Confidence

high

Schemes

Id
cdsco-electrical-emc-evidence
Name
CDSCO electrical/EMC evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
Standards hierarchy (Rule 7, Medical Devices Rules 2017): BIS or MoHFW-notified standards, else ISO/IEC or pharmacopoeial standards, else the validated manufacturer's own standards. Chapter IIIA registration (G.S.R. 102(E) rule 19B(2)(iii)) requires an ISO 13485 certificate accredited by NABCB or the International Accreditation Forum; IVD licence dossiers need a performance evaluation report from a central device testing laboratory or a rule 83(3)-registered laboratory; device testing laboratories register with the CLA (rule 81).
Source Urls
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/mdr%2C%202017%20%281%29.pdf
Source Binding
candidate
Id
wpc-eta
Name
WPC ETA
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Wireless Equipment In Licence Exempt Band
Source Urls
https://www.deveservices.dot.gov.in/equipment-type-approval-eta
Source Binding
candidate
Id
tec-mtcte
Name
TEC MTCTE
Category
Telecom Network Attachment
Status
Mandatory If Feature
Object
Notified Telecom Equipment
Source Urls
https://www.deveservices.dot.gov.in/equipment-type-approval-eta
Source Binding
candidate
Id
bis-compulsory-scheme
Name
BIS compulsory scheme
Category
General Electrical Components
Status
Mandatory If Feature
Object
Notified Product Or Component
Source Binding
unresolved
Id
aerb-x-ray-equipment-type-approval-and-supplier-import-permissions
Name
AERB X-ray equipment Type Approval and supplier/import permissions
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Product And Supplier
Source Urls
https://www.aerb.gov.in/english/regulatory-facilities/radiation-facilities/application-in-medicine/diagnostic-radiology
https://aerb.gov.in/index.php/regulatory-requirements-and-guidelines-for-suppliers-of-x-ray-equipment
Source Binding
candidate
Id
aerb-facility-operation-registration-licence
Name
AERB facility operation registration/licence
Category
Ionizing Radiation
Status
Mandatory For Use Site
Object
facility
Source Urls
https://aerb.gov.in/index.php/regulatory-requirements-and-guidelines-for-suppliers-of-x-ray-equipment
Source Binding
candidate
Id
legal-metrology-model-approval-registration
Name
Legal Metrology model approval/registration
Category
Legal Metrology
Status
Mandatory If Feature
Object
Regulated Measuring Instrument Or Packaged Product
Source Urls
https://lm.doca.gov.in/index.aspx
Source Binding
candidate

Official Sources

Authority
Department of Telecommunications
Topic
WPC equipment type approval
Url
https://www.deveservices.dot.gov.in/equipment-type-approval-eta
Authority
AERB
Topic
diagnostic radiology type approval and licensing
Url
https://www.aerb.gov.in/english/regulatory-facilities/radiation-facilities/application-in-medicine/diagnostic-radiology
Authority
AERB
Topic
supplier requirements for X-ray equipment
Url
https://aerb.gov.in/index.php/regulatory-requirements-and-guidelines-for-suppliers-of-x-ray-equipment
Authority
Department of Consumer Affairs
Topic
legal metrology
Url
https://lm.doca.gov.in/index.aspx
Authority
CDSCO
Topic
Medical Devices Rules 2017 standards hierarchy and testing laboratories
Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/mdr%2C%202017%20%281%29.pdf
Authority
CDSCO
Topic
G.S.R. 102(E) registration NABCB accredited ISO 13485
Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/MDR_G.S.R.%20102%28E%29%20dt_11.02.2020_Registration%20of%20certain%20medical%20devices.pdf

Keep researching this market

View the India resource hub →

Compare regulatory data across all countries →

Continue with this market

Need to apply India's requirements to a product?

Confirm the current CDSCO pathway, evidence, and local-role details for the actual device before filing.

Pricing