Importing medical devices in India. Here’s a description to help importers make familiar with the regulation and registration process for medical devices. For further assistance or queries contact us at contact@cliniexperts.com or visit http://cliniexperts.com/india-regulatory-services/medical-device/

1. MEDICAL DEVICE REGISTRATION
PROCESS IN INDIA- FOR IMPORTERS
- CliniExperts Services (P) Ltd.
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2. Introduction of Medical Devices

3. Introduction
‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro
use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of:
 diagnosis, prevention, monitoring, treatment or alleviation of disease,
 diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
 investigation, replacement, modification, or support of the anatomy or of a physiological process,
 supporting or sustaining life,
 control of conception,
 disinfection of medical devices
 providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or
on the human body, but which may be assisted in its intended function by such means.
Reference: http://www.who.int/medical_devices/full_deffinition/en/

4. Definition
 Medical Devices are notified as DRUGS under Drugs & Cosmetics Act 1940 & Rules
1945.
 Section 3 (b) (iv) of D&C Act, 1940, defines Medical Devices as-
Devices intended for internal or external use in the diagnosis, treatment, mitigation or
prevention of disease or disorder in human beings or animals.
Reference: http://www.cdsco.nic.in/writereaddata/Drugs&CosmeticAct.pdf (Page No-2)

5. Classification
 No specific medical device classification currently exists in
India.
 Devices notified (regulated) by the Indian government must
register with the CDSCO.
 Non-Notified devices do not require CDSCO registration, and
may be imported into India according to formal customs
rules.
 Non-Notified Medical Device: The Devices which are not
notified under the drugs and cosmetics act.

6. Regulation Of Medical Devices In India
In India import, manufacturing, sale and distribution of Medical
devices is regulated under Drugs and Cosmetics Act, 1940; and
Rules, 1945. At present following notified Medical Devices are
regulated under the said Act.

7. Notified Medical Devices
1. Disposable Hypodermic Syringes
2. Disposable Hypodermic Needles
3. Disposable Perfusion Sets
4. In vitro Diagnostic Devices for HIV,
HbsAg and HCV
5. Cardiac Stents
6. Drug Eluting Stents
7. Catheters
8. Intra Ocular Lenses
9. I.V. Cannulae
10. Bone Cements
11. Heart Valves
12. Scalp Vein Set
13. Orthopedic Implants
14. Internal Prosthetic Replacements
Currently, there are 14 medical devices have been notified as Drugs. These are-
Reference: http://www.cdsco.nic.in/writereaddata/list-of-notified-medical-
device(1).pdf

8. Import And Registration Of Medical
Devices

9. Rules Related To Registration Of
Medical Devices In India

10. Rules Related To Registration Of Medical
Devices In India
 RULE 24: Form and manner of application for Registration Certificate
1) An application for issue of a Registration Certificate shall be made to the
licensing authority in Form 40, either by the manufacturer himself, having
a valid wholesale license for sale or distribution of drugs under these rules,
or by his authorized agent in India, either having a valid license under the
rules to manufacture for sale of a drug or having a valid wholesale license
for sale or distribution of drugs under these rules
 RULE 25 B: Registration Certificate for import of drugs manufactured by
one manufacturer.

11. Rules Related To Registration Of Medical
Devices In India
 Rule 27-A: Grant of Registration Certificate.
 Rule 28-A: Duration of Registration Certificate
 Rule 29A: Suspension and cancellation of Registration Certificate.
 Rule 109-A: Labeling of Medical Devices
 Rule 125-A: Standards for Medical Devices
 Schedule M III Rule: GMP Requirements
Reference: http://www.cdsco.nic.in/writereaddata/Drugs&CosmeticAct.pdf
(Page Nos. 38,40,41,128,142)

12. Registration & Import Procedure

13. Registration Of Medical Devices
 The import of notified medical devices need to be registered under the drug and
cosmetics act 1940 and Rules 1945 (as amended). Not only medical devices but
the manufacturing site needs to be registered for import.
 The application for Import Registration and Import License can be made to the
Licensing Authority under the Drugs and Cosmetic Act, 1940 and Rules 1945 as
amended i.e. to the Drugs Controller General (I) at CDSCO, FDA Bhawan, Kotla
Road, Near Bal Bhawan, New Delhi by the Local Authorized Agent of the foreign
manufacturer having a wholesale License in the country and will be accompanied
by the requisite fee and the information and undertakings specified in Schedules D-
I and D-II duly signed by or on behalf of the manufacturer.

14. Registration Of Medical Devices (Contd.)
 There are two steps that need to be followed for import of Notified medical devices:
1) Import Registration (Form 41)
2) Import License (Form 10)
The application for Import Registration and Import License can be made to the
Licensing Authority as per CDSCO Pre-Screening Checklist.
Reference: http://www.cdsco.nic.in/writereaddata/Revised-pre-screening-Checklist-for-
Medical-Devices-&-In-vitro-Diagnostics-applications.pdf

15. Summary of Registration & Import
Procedure
Medical Device
Appoint an Indian Authorized Agent who must have a valid wholesale license (Forms 20B
and 21B).
Grant Power of Attorney to your India Authorized Agent to manage registration in India.
File application for Device Registration Certificate to CDSCO using Form 40. Schedules D-1
and D-2 must be included, as well as verification of compliance with US, Canadian,
European, Japanese or Australian regulations.
Device manufacturers new to India require a Form 45 (New Drug License) in support of the
Form 40 application.
Obtain Registration Certificate Form 41 from CDSCO.

16. Summary of Registration & Import
Procedure (Contd.)
Identify distributor in India (holding forms 20B and 21B).
Apply for Import License using Forms 8 and 9 with rest of documents mentioned.
Obtain Import License (Form 10) from CDSCO.
You are now authorized to market your Medical Device products in India.

17. Documents Required For Registration Of
Medical Devices In India
1. Covering Letter
2. Authorization letter
3. Application in Form-40
4. TR-6 Challan
5. Apostilled Power of Attorney
6. Notarized Valid Wholesale license or
Manufacturing license of the Indian Agent
7. Schedule DI
8. Schedule DII
9. Duly Apostilled/Notarized Free Sale Certificate
10. Duly notarized PMS Study Report for last three
years (In case of re-registration)
11. Duly notarized valid copies of Quality
Certificate in respect of the legal and actual
manufacturing site (s) (wherever applicable)
(a) Certificate supporting Quality
Management System (b) Full Quality
Assurance Certificate / CE Type Examination
Certificate/ CE Product Quality Assurance (c)
CE Design Certificate (d) Declaration of
Conformity.
12. Notarized Plant Master file
13. Notarized Device Master File
14. Notarized IFU, Pack Insert of the devices.
15. Notarized Device Label

18. Documents Required For Import License
(Form 10)
 After getting the registration certificate from CDSCO, following documents are
further required to get Form 10 (Import license).
 Cover Letter
 Form-8 duly Signed & Stamped by applicant
 TR Challan- (Rs.1000 for 1st product then Rs.100 for each additional product)
 Form 9 (Undertaking given by Manufacturer or on behalf of manufacturer)
 Notarized copy of Wholesale License or Manufacturing License
 Copy of Registration Certificate in form 41.
 Notarized Labels of the device
Post grant of import license, the Indian agent can now import the products from the
manufacturer.

19. New Medical Device

20. Definition & Introduction
 New Medical Device: A “new” medical device is one which does not have a predicate medical device
registered / approved in India.
 Predicate Medical Device: A “predicate” medical device is one which is registered / approved in India
and has the same indications/ intended use, material of construction and design characteristics as
the device which is proposed for registration in India.
 Notified medical devices for which predicate devices are not registered in India are classified as
“new” medical devices. These medical devices are referred to the Medical Device Advisory
Committees (MDAC) to comment on safety, effectiveness, essentiality and desirability of proposed
New Devices.
 In case of New Devices/not yet approved in India, the applicant has to submit a copy of necessary
permission/NOC from the Drugs Controller General (I) along with the application.
Reference: http://www.cdsco.nic.in/writereaddata/FAQ-IMPORT-&-REGISTRATION-
02022013_DONEE.pdf (Page No. 9)

21. Approval Process for New Medical Device
Appl. in
Form44 as
per Schedule
Y and
TR6 Challan
of Rs.50000/
Review of
Clinical Trial
Protocol,
Published
reports,
literature,
Package Insert
etc. by CDSCO
Evaluation
By Medical
Device
Advisory
Committee
On Basis of
Recommen
dations of
MDAC
Permission
Under
Rule-122A
granted
Registration
and
Form-10

22. Applicable Fee, Timeline & Validity
Registration
Certificate(RC)
and Import
License-
Valid for 3 years
VALIDITY
Timeline as per
D&C Rules
For RC- 9 months
For Import
License- 45 days
TIMELINE
Application Fees:
Mfg. Site Registration- 1500
USD per Site
Product Registration- 1000
USD per device
Application Fees- Import
License (Form 10)
For one proposed device-
INR 1000
For each additional device-
INR 100.
FEE

23. Thank You