Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India. Indian market overview India’s medical device regulatory structure Categories of regulated medical devices in India No Objection Certificates Device Registration Certificate applications Import Licensing India Authorized Agent selection Costs and Timelines Developing Regulatory Issues in India

1. Medical Device
Registration in
India
Steps to register and sell medical device in
the Indian market
BY : CHETAN N. UMALE
Regulatory Affairs

2. Key Topics
 Indian market overview
 India’s medical device regulatory structure
 Categories of regulated medical devices in India
 No Objection Certificates
 Device Registration Certificate applications
 Import Licensing
 India Authorized Agent selection
 Costs and Timelines
 Developing Regulatory Issues in India

3. Indian Market Overview
Economic and demographic trends are driving medical device industry
interest in the Indian market
• India’s medical device market will reach $6 billion by 2015
• The number of Indian citizens over the age of 60 will reach 200 million by 2025
• “Medical tourism” attracts hundreds of thousands of visitors to India each year
• A rising Indian middle class is seeing increased incidence “lifestyle diseases” such as
heart disease and diabetes
Imports as a percentage of India’s GDP
have grown at a steady rate.
1970 – 4%
1990 – 8%
2010 – 25%
Sustained Indian demand for imported goods
includes medical devices. India relies on
imports for about 75% of its medical device
demands.
Opportunity for medical device exporters!

4. India’s Medical Device Market: Import-Dependent
India’s medical device market is highly dependent on imports:
about 75% of the country’s demand for medical devices is met
via imported products.
India’s Largest Medical Device
Importers
US (29%)
Germany (20%)
Other Countries (19%)
Other EU Countries (17%)
China (8%)
Japan (7%)

5. Longer Life Expectancies
Rising life expectancy rates in India means growing demand for
medical devices and health care products as more people age.
1960 – 43 1970 – 49
1980 – 55 1990 – 58
2000 – 62 2010 – 65
Healthcare Spending Increasing
As India’s economy expands, health-related expenditures are also rising.

6. Indian States and Territories
India has 28 states and 7 union territories, presenting potential challenges in
terms of distribution of medical device. Careful selection of distribution partners
is essential.

7. India’s Medical Device Regulatory Structure
Ministry of Health and Welfare
Drug Controller General of India (DCGI)
Central Drugs Standard Control Organization (CDSCO) – Medical Devices
Division

8. India’s Medical Device Regulatory
Structure
• India had no regulations for medical devices in place prior to 2005.
• The registration process for medical devices in India remains fluid, but regulators
are taking steps to develop a more formalized oversight policy.
India’s Medical Device Regulatory Structure
• The import, manufacturing, distribution and sale of medical devices in India are
overseen by the Drugs and Cosmetics Act (1940) and Rules (1945).
• 22 medical devices are currently “notified” under the Drugs & Cosmetics Act.
• Controls and inspections are carried out by the CDSCO, state drug controllers
and central/state laboratories.

9. Device Classification in India
• 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.

10. Disposable hypodermic syringes Condoms
Disposable hypodermic needles Tubal rings
Disposable hypodermic perfusion sets Surgical dressings
In vitro diagnostic devices for HIV, HBsAg
and HAV
Umbilical tapes
Cardiac stents Blood/blood component bags
Catheters Drug eluting stents
Disposable hypodermic needles
Intra ocular lenses
Disposable hypodermic syringes
Disposable hypodermic perfusion sets Intra ocular lenses
IV cannulae Heart valves
Bone cements Intra uterine devices
Scalp vein sets Skin ligatures, sutures and staplers
Orthopedic implants Blood grouping sera
Internal prosthetic replacements
List of Notified Medical Devices
The list of medical devices notified for registration with CDSCO (as of
February 2012) includes the following products:

12. No Objection Certificate (NOC) letter
The DCGI will review certain product information and provide written determination on
the regulatory status of a medical device 4 to 12 weeks to process applications
Registration Validity and Timeframes
Registration Certificates (Form 41) and Import Licenses (Form 10) are valid for 3 years
Following submission of your registration application, it typically takes 6 to 9 months for
CDSCO to issue the Registration Certificate
It usually takes 4 to 5 weeks to obtain an Import License
A provision of the Drugs & Cosmetics Act mandates inspections of overseas
manufacturing sites, at a cost of US$5000 to manufacturers

13. India’s Device Registration Process
Registration Checklist
The following documentation is required in order to apply for medical device registration
certification in India:
1. Covering Letter: states the intent of the application and lists all documents being submitted with
the application
2. Authorization Letter: identifies our India Authorized Agent
3. Form 40: general medical device registration application form
4. TR6 Challan: registration fee payment--$1,500 per site, $1,000 per device
5. Power of Attorney: necessary for proof of authorization from manufacturer to India Authorized
Agent; must be notarized by Indian embassy in device’s country of origin
6. Schedule DI and Plant Master File: information on device and manufacturing site(s)
7. Schedule DII and Device Master File: information on intended use, indications for use,
classification and any novel features, clinical data, post-market surveillance data and other details
8. Wholesale License: permits our India Authorized Agent to act on behalf of us.
9. Free Sale Certificate (FSC): must be from device’s country of origin; an FSC from a GHTF
country may also be required

14. 10. Manufacturing License: must be issued by the regulator of the device’s country of origin; also
known as Establishment Registration Certificate
11. ISO 13485:2003 Certificate: must be in place for the foreign manufacturing site
12. Quality Assurance Certificate: must be in place for the foreign manufacturing site
13. CE Design Examination Certificate: must be in place for device
14. Declaration of Conformity: must be in place for device
15. Inspection/Audit Report: must be carried out by appropriate Notified Body, national regulatory
authority or Competent Authority

15. Costs and Licensing Fees
Requisite fees prescribed by the Drugs & Cosmetics Act for
medical device registration include:
$1,500 for registration of manufacturing premises
$1,000 for device, plus $1,000 per additional device to be
imported to India
Labeling Requirements: “add on label” for India normally
includes the following
Imported & Marketed by:
MRP: Rs. xxxx/- (incl. of all taxes).
Qty:
Brand name:
Import Lic. No.:
"For further information or any complaints or queries please visit
website or call Customer care Executive at +91-xxxxxxxxxx"
Imported on: mm – yyyy

16. Form 10 Import License
Required of any registered medical device and non-critical IVD reagents
4 to 12 weeks to process application and issue license Rs1,000 for the first product on
an import license and Rs100 for any additional products from same manufacturing site
an in same Form 41
Device Family Categorizations
Determining product’s Device Family is crucial for registration process in India, and for
calculating associated fees will need to pay. The DCGI defines device families as
follows:
A group or family of devices manufactured by or for the same manufacturer, having the
same basic design, performance characteristic related to the device safety, effectiveness
and intended use (including variation in sizes and shapes) would be considered as one
single device. Further, a device may also include a package of various devices or sub-
systems that are required to be used together as a single functioning device that may
include variation in size or shape without any change in material or method of use.

17. Clinical Trials in India
Important: because India’s medical device regulations are currently based on the
country’s drug regulations, Phase III clinical trials in India are technically required for all
products notified for registration. It cannot be assumed that if product has already
obtained US FDA clearance or approval, for example, will not need to conduct further
clinical trials in India.
Clinical trials in India may be required for device regardless of the quality of any
existing clinical data may have already acquired for device in another market.
Combination as well as cardiovascular devices also often require clinical trials as part of
the Indian registration process.

18. India Authorized Agent Requirements
Foreign manufacturers with no local presence in India must appoint India
Authorized Agents to manage registration as well as post-market surveillance
requirements.
India Authorized Agent
India Authorized Agent is a person or company responsible for device registration and
liaising between manufacturer and the CDSCO’s Medical Devices Division. If device is
on the list of regulated devices in India, manufacturer must appoint an India Authorized
Agent to represent manufacturer.
India Authorized Agent Role and Responsibilities
• Must be a resident of India
• Must have prior experience in the healthcare industry
• Authorized through power of attorney to submit medical device registration documents
to CDSCO and act as point of contact between manufacturer and CDSCO
• Acts on manufacturer’s behalf in the event of an onsite inspection of manufacturer’s
facility

19. • At CDSCO’s request, the India Authorized Agent provides information on the
manufacturer’s device as well as designated distributors in India
• The India Authorized Agent also assists with coordination of inspections if regulators
select the manufacturer for an audit
• The India Authorized Agent must hold Drug Wholesale Licenses 20-B and 21-B
Regulatory Developments in India
The Indian health ministry is planning significant changes to its regulatory approach for
medical devices. Revisions will include:
Defining and regulating medical devices separately from drugs
Bringing ALL medical devices under regulation in India
Establishing a risk-based device classification system
Establishing clinical trial protocols
Setting up conformity assessment procedures
Increasing staff and resources at the CDSCO