CDSCO market access

India medical device registration resources

Research CDSCO registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every India medical device resource.

71,807 license records11 free resources25/25 requirements covered22 regulations trackedAug 2026 fees reviewed

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Medical device registration database

Search official CDSCO device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official CDSCO regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current CDSCO application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely CDSCO pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent CDSCO policy, guidance, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary CDSCO risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other India requirements.

AI similar registered product finder

Describe a device and find comparable products in the CDSCO registration database.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 45 source-linked facts →

25 of 25 research dimensions currently covered · 17 official sources · latest verification 2026-08-30

Market entry

D01

Authority & regime

Verified

Competent authority: 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 performa…

1 source-linked fact

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Primary rules and commencement: 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…
Chapter IIIA registration of all notified devices and transition: 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…

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

All-device definition: 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 pri…
Devices regulated as drugs: 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 preventi…

2 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

Risk classes A through D.: Class A, Class B, Class C, Class D

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Market-access route: 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 b…
Class A non-sterile non-measuring registration route: 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 certi…

3 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

Free sale certificate reliance for import: 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…

1 source-linked fact

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Indian authorised agent requirement: 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 hol…
Change of authorised agent: 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 c…

2 source-linked facts

Checked 2026-08-26

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D08

Establishment, import & distribution

Verified

Sale registration certificate (Form MD-42): 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, gra…

1 source-linked fact

Checked 2026-08-25

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D09

Dossier requirements

Verified

Import dossier evidence: Import licence applications require: notarised overseas plant registration and free sale certificate from the country of origin; notarised QMS certificate (or Full/Production Quality Assura…
Power of attorney legalisation: 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 cou…

2 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Import application form and portal: 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.

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Label particulars and symbols: 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 us…
Electronic instructions for use: 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.

3 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

QMS evidence for market access: The Fifth Schedule QMS (design, manufacture, packaging, labelling, testing, installation, servicing) applies to manufacturers; for import and Chapter IIIA registration a notarised ISO 13485…
Notified Body audit timing: 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: audi…

2 source-linked facts

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Verified

CDSCO electrical/EMC evidence: Electrical safety
WPC ETA: Wireless / radio
TEC MTCTE: Telecom terminal

7 maintained overlays

Checked 2026-08-29

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D14

Fees

Verified

Import licence - Class A manufacturing site: USD 1,000
Import licence - Class A device: USD 50

21 maintained fee lines

Checked 2026-08-25

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D15

Review clocks

Verified

Class A · Registration: 45 days
Class B · Registration: 45-140 days
Class C · Registration with clinical data: 90 days

4 maintained pathways · 2 related facts

Checked 2026-08-30

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D16

Approval validity & renewal

Verified

Perpetual licence validity: 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…
Lapse on non-payment: 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).

3 source-linked facts

Checked 2026-08-26

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Lifecycle & post-market

D17

Change control

Verified

Change-control outcomes: 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…
Fresh application triggers: 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 ex…

3 source-linked facts

Checked 2026-08-26

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D18

UDI, listing & traceability

Verified

UDI deferred pending Central Government order: 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 i…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical investigation permission: 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…
No-predicate device permission: 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 extenda…

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Government hospital import of investigational devices: 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, diseas…
Custom-made device exemption: 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…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Periodic Safety Update Reports: 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 f…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Suspected unexpected serious adverse event reporting: 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 d…
Foreign regulatory action reporting by importers: 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 withdr…

3 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Recall duty and authority directions: 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 rea…

1 source-linked fact

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Definitions used by the Drugs and Magic Remedies Act: 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…
Prohibited disease and condition claims: 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,…

5 source-linked facts

Checked 2026-08-26

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D25

Submission communications & appeal

Verified

Appeal against import refusal: 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 fou…
Appeal against import licence suspension or cancellation: 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…

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (21 lines) →

CDSCO registration fees in USD · reviewed 2026-08-25

Fee line	Amount	Provenance
Import licence - Class A manufacturing site	USD 1,000	Verified
Import licence - Class A device	USD 50	Verified
Import licence - Class B manufacturing site	USD 2,000	Verified
Import licence - Class B device	USD 1,000	Verified

17 more fee lines on the full schedule · 21 of 21 rows source-verified

Registration timeline

Full registration timeline →

Central Drugs Standard Control Organisation (CDSCO) review clocks and planning ranges · 4-class (A, B, C, D) classification

Class / pathway	Review clock	Planning total	Provenance
Class A(Registration)	45 days	6-9 months	Verified
Class B(Registration)	45-140 days	8-12 months	Verified
Class C(Registration with clinical data)	90 days	1-1.5 years	Verified
Class D(Registration with extensive clinical)	90 days	1.3-2 years	Verified