Medical device and Patency By MDD 93/42 Any devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; investigation, replacement or modification or support of the anatomy or of a physiological process; supporting or sustaining life; disinfection of medical devices; and control of conception. What is 510(k) ? A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(a) FD&C act). 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” India had no regulation for medical devices in place prior to 2005. The import, manufacturing, distribution and Sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945) Control and inspection are carried out by the CDSCO, state drug controllers and central/state laboratories.

1. MEDICAL DEVICE & PATENCY
SHRUTI GANGURDE
1st year
M.Sc in Clinical
Research

2. What Is A Medical Device?
By MDD 93/42
Any devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone
or in combination, including a software or an accessory, intended by its manufacturer to be used specially for
human beings or animals which does not achieve the primary intended action in or on human body or animals by
any pharmacological or immunological or metabolic means, but which may assist in its intended function by
such means for one or more of the specific purposes of ―
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception.

3. MEDICAL DEVICES
BY
USA

5. What is 510(k) ?
A 510(k) is a premarket submission made to FDA to demonstrate
that the device to be marketed is as safe and effective, that is,
substantially equivalent, to a legally marketed device
(section 513(i)(1)(a) FD&C act).
FD&C Act Chapter V: Drugs and Devices
FD&C Act Section Number  Sec. 510.
Title 21 U.S.C. § (section) 360
(Registration of procedures of Drugs and Devices)
Sub section - (k)
Part A – Drugs and Devices
(sections 351 – 360n-1)
Code of Federal Regulations - Title 21 - Food
and Drugs

9. MEDICAL DEVICES
BY
INDIA

10. 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”
India had no regulation for medical devices in place prior to 2005.
The import, manufacturing, distribution and Sale of medical devices in India are overseen by the Drugs and
Cosmetics Act (1940) and Rules (1945)
Control and inspection are carried out by the CDSCO, state drug controllers and central/state laboratories.
INDIAN MEDICAL DEVICE REGULATORY STRUCTURE

11. The Drug & Cosmetic Act
• Covers the pharmaceutical products
and cosmetic. Added medical
devices as early as1992(syringes ,
needles, etc.)
• Additionally following products are
regulated as ‘Drugs’ under Drugs &
Cosmetics Act & Rules there under:-
- Blood grouping sera
- Ligatures , sutures & staplers
- Intra uterine devices, Condoms
- Tubal rings
- Surgical dressings
- Umbilical cord
- Blood/blood related products
S.No. Name of the Device Date of Notification
1 Disposable Hypodermic Syringes 17-03-1989
2 Disposable Hypodermic Needles 17-03-1989
3 Disposable Perfusion Sets 17-03-1989
4
In vitro Diagnostic Devices for HIV,
HBsAg and HCV
27-08-2002
5 Cardiac Stents 06-10-2005
6 Drug Eluting Stents 06-10-2005
7 Catheters 06-10-2005
8 Intra Ocular Lenses 06-10-2005
9 I.V. Cannulae 06-10-2005
10 Bone Cements 06-10-2005
11 Heart Valves 06-10-2005
12 Scalp Vein Set 06-10-2005
13 Orthopedic Implants 06-10-2005
14 Internal Prosthetic Replacements 06-10-2005
15 Ablation Devices 25-01-2016

13. Function Of Medical Device Division
• Grant of Certificate of Registration for a Notified Body for audit of Class A and Class B Medical Devices
• Grant of Import License or loan license to manufacture for sale or for distribution.
• Grant of test license to manufacture for test, evaluation, clinical investigations & to import for test, evaluation, clinical investigations, etc.
• Grant of license to Import investigational medical device by Government hospital or statutory medical institution for treatment of patient
• Permission to conduct clinical investigation of Investigational Medical Device & clinical performance evaluation for new in vitro diagnostic
medical device
• Permission to import or manufacture medical device which does not have its predicate device & new in vitro diagnostic medical device
• Registration of Medical Device Testing Laboratory
• Preparation of Guidance and FAQ on key activities.
• Processing of application for Issuance of Free Sale Certificate for domestic manufacturers Medical Devices.
• Processing of application for Issuance of Market Standing Certificate and Non- Conviction for Medical Devices
• Complaint, Not of Standard Quality (NSQ) Verification.
• Updating the list as per the Classification of Medical Devices from time to time.
• Post Approval Changes in respect of Medical Devices.
• Constitution of MD experts committee.
• Inspection of manufacturing site for compliance of QMS by CLA/SLA.
• Capacity building activities of technical management.
• Preparing and submitting replies of Parliament Questions/RTIs/Clarifications/NOCs/ Port office queries
• Providing clarification to applicant on the regulatory status of products

14. Many committees had been set up and given their opinion and recommendation , like the Mahelkar
Committee – Central Drug Standard Control Organization. All these are now being taken into to form the
Indian Medical Device regulatory Act (IMRDA)
Indian Medical Devices Regulatory Act come in force December 31, 2009.
According to proposed M-III draft by CDSCO
Class Risk Level Device Examples
A Low Risk Thermometers/ tongue depressors
B
Low-Moderate
Risk
Hypodermic needles/ suction
C
Moderate-High
Risk
Lung ventilators/ bone fixation plate
D High Risk Heart valves/ implantable defibrilator
BY CDSCO (IMRDA) & MDD- RISK BASED CLASSIFICATION
Other Six Medical Device
Advisory Committees Constituted
• MDAC- Cardiovascular
• MDAC- Dental
• MDAC- Reproductive and
Urology
• MDAC- Orthopedics
• MDAC- Ophthalmic
• MDAC- Miscellaneous

15. Phases Of Medical Device
Conception
And
Development
Manufacture Sale Use Disposal
Packaging
And
Labelling
Advertising
1 2 3 4 765
MANUFACTURER VENDOR USER

16. MEDICAL DEVICE REGULATION
1. For the import of medical devices in India, Registration Certificate in Form 41 and Import
License in Form 10 are required as per provisions of the Drugs & Cosmetic Act & Rules.
2. Requirements of Import License (Form 10): (2-3 months)
Covering Letter
Self-attested copy of authorization letter
Form-8
Form-9
Notarized copy of Wholesale Licence or Manufacturing Licence of the Indian Agent
Copy of Registration Certificate in form-41
Documents as stated in Registration Certificate (In case of conditional certificate)
Notarized Labels of the device as per Rule 109 A of Drugs & Cosmetics Rules.

17. IMPORT, REGISTRATION & LICENSE

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

19. Approval For New Medical Devices
Application in Form
44 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

20. MARKETING AUTHORIZATION

21. MARKETING AUTHORIZATION FOR IMPORT DEVICES

22. 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
In June of 2016, the FDA issued a final rule

23. SAMPLE OF LABELLING

24. THE INDIAN PATENT ACT
• “A patent is a grant from the government which confers on the guarantee for a limited period of time the
exclusive privilege of making, selling and using the invention for which a patent has been granted.”
• In India the grant of patents is governed by the patent Act 1970 and Rules 1972.
• The patents granted under the act are operative in the whole of India.
• History:-
The Patent Law of 1856
The Patent and Designs Act, 1911.
The Patents Act, 1970 and Rules 1972
The Patent amendment act 2005

25. TYPES OF PATENTS
Three types of patent are granted under the provisions of the act, namely:
• An Ordinary Patent: Is one which is granted on the basis of general & ordinary procedure of
application.
• A Patent Of Addition: It is a Patent secured for an improvement or modification of an invention,
for which a patent has already been applied for or granted.
• A Patent Of Convention: Patent granted under convention agreement.
A second type of classification of patent is:
• Product Patent
• Process Patent

26. PROCEDURE FOR PATENCY
Filling of patent application
Publication after 18 months
Pre-Grant Opposition/ Representation by any person
Request for Examination
Examination: Grant or Refusal
Post Grant Opposition to grant of patent
Publication for Grant of patent
Decision by controller

27. Documents Required For Filling Of A Patent Application
• Covering letter-indicating the list of documents;
• Application for Grant of Patent in Form 1 [section 7, 54 & 135 and Rule 20(1)] in duplicate;
• Complete/Provisional specification in Form 2 in duplicate [Section 10; Rule 13]
• Statement and Undertaking in Form 3 [Section 8; Rule 12];
• Power of Attorney in Form 26 (in original) (Rule 3.3 (a) (ii)); (if filed through attorney)
• Declaration of Inventor-ship in Form 5 (only in case of an Indian Application; (Rule 4.17);
• Request for examination: F18
• Requisite Statutory fees (cheque / DD).

28. REFERENCE
• https://www.fda.gov/medical-devices
• https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-
market-your-device
• https://www.fda.gov/regulatory-information/federal-food-drug-and-cosmetic-act-fdc-act/fdc-act-chapter-v-
drugs-and-devices#Part_A
• https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
• https://www.mondaq.com/india/patent/54494/patent-law-in-india?type=popular
• https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/
• https://www.slideshare.net/bdvfgbdhg/medical-device-16068264
• https://www.slideshare.net/surajpamadi/medical-device-regulations-in-india
• https://www.slideshare.net/AnkitGeete/regulation-of-medical-devices-in-us
SEPRATE SAMPLE OF FORMS WILL BE PRESENTED AND PLZ ASK IF REQUIRED