The document outlines the regulatory framework for medical devices in India under the Drugs & Cosmetics Act, including definitions and classifications. It details the registration, licensing, and import processes for medical devices, as well as the fees and necessary application forms. Additionally, it mentions the roles of the Medical Device Advisory Committees (MDAC) in evaluating new medical devices for approval.

1. Medical Device Regulations
In India
3rdevaluationseminar
Facilitated by
DR. BALAMURALIDHARA V
Asst . Professor- Regulatory
Affairs Group
Dept. of pharmaceutics
JSSCP, Mysore
Presented by:
SURAJ P.S
1st M. Pharm ,
Pharma Regulatory
Affairs,
JSSCP, Mysore.

2. Medical Devices are notified as DRUGS under Drugs &
Cosmetics Act.
Section 3 (b) (iv) 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”

3. 14 medical devices have been notified as Drugs

4. B
A C
D

6. Functions of Medical Device Division
•Import Registration and Licensing of Medical
Devices
•Approval of New Medical Devices
•Manufacturing License to Indigenous Manufacturer
under CLAA Scheme
•Grant of Test License
•NOC’s for Import/Clarifications
•Neutral Code For Export
•Clinical Trials

7. Import. Registration & Licensing
Mfg sites and Products are required to be Registered
Issue of Registration Certificate in Form 41
Issue of Import License in Form 10 / 10A
Rules
21 to 30
Schedule
DI & DII
Rules related to grant of Registration
Certificate and Import License
Information required for registration of
Mfg site and Product
Rules
21 to 30
Registration Certificate(RC) and
Import License - Valid for 3 years

8. Import Procedure
Application For Registration
(Form- 40/ Schedule D(I)/ Schedule D(II), Power of Attorney)
Registration Certificate issued by CDSCO
(Form-41)
Application For Import License
(Form-8, Form 9)
Import License issued by CDSCO
(Form- 10)
Application Fees:
Mfg. Site
Registration
1500 USD per Site
Product
Registration
1000 USD per
product

9. Approval of New Medical Devices
Appl. in Form44 as per Schedule Y
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 Recommendations of MDAC
Permission Under Rule-122A granted
Registration
and
Form-10

10. Six Medical Device Advisory Committees
Constituted
MDAC - Cardiovascular
MDAC -Dental
MDAC - Reproductive and
Urology
MDAC - Orthopedics
MDAC - Ophthalmic
MDAC - Miscellaneous

13. You are now authorized to market your device or IVD in
India.
Obtain Import License (Form 10) from CDSCO. License valid
for up to 3 years, or until the Registration Certificate expires
Apply for Import License using Forms 8 and 9 available from
CDSCO. You must identify your chosen distributors on these
forms as well.
Identify your distributor in India (holding forms 20B and
21B).

14. According to rule 96, the following items must
be on the labeling for Notified Devices
• product description
• number of units of contents
• The name of the manufacturer and the address of the premises of
the manufacturer where the product has been manufactured
• A distinctive batch number, being preceded by the words ‘Batch No.’
or ‘B. No.’ or ‘Batch’ or ‘Lot No.’ or ‘Lot’.
• Date of manufacture, and the date of expiration

16. Reference
• http://cdsco.nic.in/html/sec_122_a.htm
• Drug&cosmetic Act