Medical Device RegulationsIn India

3rd

eval

uat

ion

sem

inar

Facilitated byDR. BALAMURALIDHARA VAsst . Professor- Regulatory Affairs GroupDept. of pharmaceuticsJSSCP, Mysore

Presented by:SURAJ P.S1st M. Pharm ,Pharma RegulatoryAffairs,

JSSCP, Mysore.

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”

14 medical devices have been notified as Drugs

B

A C

D

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

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

Rules21 to 30

ScheduleDI & DII

Rules related to grant of Registration

Certificate and Import License

Information required for registration of

Mfg site and Product

Rules21 to 30

Registration Certificate(RC) and

Import License - Valid for 3 years

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

Registration1500 USD per Site

Product Registration

1000 USD perproduct

Approval of New Medical Devices

Appl. in Form44 as per Schedule YTR6 Challan of Rs.50000/

Review of Clinical Trial Protocol, Published reports,literature, Package Insert etc by CDSCO

Evaluation By Medical Device AdvisoryCommittee

On Basis of Recommendations of MDAC

Permission Under Rule-122A granted

Registration and

Form-10

Six Medical Device Advisory Committees Constituted

MDAC - Cardiovascular

MDAC -Dental

MDAC - Reproductive and Urology

MDAC - Orthopedics

MDAC - Ophthalmic

MDAC - Miscellaneous

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).

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

Reference

• http://cdsco.nic.in/html/sec_122_a.htm

• Drug&cosmetic Act