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.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
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
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
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
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
This short presentation is giving a brief introduction of the general status of china medial device industry, as well as an explanation about the CFDA and the medical registration process in china
the overall summary of regulation of herbal drugs in India and what document required for getting approval and summary of GMP, GCP guideline with labelling requirement.
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Importing and Exporting Drugs & Medical DevicesMichael Swit
Presentation (in outline form) to the Workshop on Importing and Exporting Drugs and Devices, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, given on March 19, 2002.
Medical device management in china and latest regulatory updates_EdwinCIRS China
Currently, China is one of the world's most promising markets for medical devices, which on the back of its vast market size, offers huge potential to medical device companies. All medical devices marketed or sold for use in China must be registered with China Food and Drug Administration (CFDA).
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
New Drug approval process in India, rules, and regulation according to schedule Y (Drug and cosmetics act 1940 ).
Fees and form for the submission of application.
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
This short presentation is giving a brief introduction of the general status of china medial device industry, as well as an explanation about the CFDA and the medical registration process in china
the overall summary of regulation of herbal drugs in India and what document required for getting approval and summary of GMP, GCP guideline with labelling requirement.
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Importing and Exporting Drugs & Medical DevicesMichael Swit
Presentation (in outline form) to the Workshop on Importing and Exporting Drugs and Devices, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, given on March 19, 2002.
Medical device management in china and latest regulatory updates_EdwinCIRS China
Currently, China is one of the world's most promising markets for medical devices, which on the back of its vast market size, offers huge potential to medical device companies. All medical devices marketed or sold for use in China must be registered with China Food and Drug Administration (CFDA).
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
New Drug approval process in India, rules, and regulation according to schedule Y (Drug and cosmetics act 1940 ).
Fees and form for the submission of application.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
A BRIEF OVERVIEW ABOUT CDSCO.
YOU CAN DOWNLOAD FILES FROM HERE-
MY SLIDESHARE ACCOUNT-
https://www.slideshare.net/varshawadnere
IF YOU HAVE ANY DOUBTS YOU CAN ASK ME THROUGH EMAIL-
pharmacypharmd8@gmail.com
THANK YOU.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
a concise yet very informative presentation, on drug approval process and clinical trial regulations in India, prepared for clinical research students
Please refer notes for abbreviations and additional information
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
This presentation explores a brief idea about the structural and functional attributes of nucleotides, the structure and function of genetic materials along with the impact of UV rays and pH upon them.
What is greenhouse gasses and how many gasses are there to affect the Earth.moosaasad1975
What are greenhouse gasses how they affect the earth and its environment what is the future of the environment and earth how the weather and the climate effects.
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
A brief information about the SCOP protein database used in bioinformatics.
The Structural Classification of Proteins (SCOP) database is a comprehensive and authoritative resource for the structural and evolutionary relationships of proteins. It provides a detailed and curated classification of protein structures, grouping them into families, superfamilies, and folds based on their structural and sequence similarities.
Seminar of U.V. Spectroscopy by SAMIR PANDASAMIR PANDA
Spectroscopy is a branch of science dealing the study of interaction of electromagnetic radiation with matter.
Ultraviolet-visible spectroscopy refers to absorption spectroscopy or reflect spectroscopy in the UV-VIS spectral region.
Ultraviolet-visible spectroscopy is an analytical method that can measure the amount of light received by the analyte.
This pdf is about the Schizophrenia.
For more details visit on YouTube; @SELF-EXPLANATORY;
https://www.youtube.com/channel/UCAiarMZDNhe1A3Rnpr_WkzA/videos
Thanks...!
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
Normal Cell Metabolism:
Cellular respiration describes the series of steps that cells use to break down sugar and other chemicals to get the energy we need to function.
Energy is stored in the bonds of glucose and when glucose is broken down, much of that energy is released.
Cell utilize energy in the form of ATP.
The first step of respiration is called glycolysis. In a series of steps, glycolysis breaks glucose into two smaller molecules - a chemical called pyruvate. A small amount of ATP is formed during this process.
Most healthy cells continue the breakdown in a second process, called the Kreb's cycle. The Kreb's cycle allows cells to “burn” the pyruvates made in glycolysis to get more ATP.
The last step in the breakdown of glucose is called oxidative phosphorylation (Ox-Phos).
It takes place in specialized cell structures called mitochondria. This process produces a large amount of ATP. Importantly, cells need oxygen to complete oxidative phosphorylation.
If a cell completes only glycolysis, only 2 molecules of ATP are made per glucose. However, if the cell completes the entire respiration process (glycolysis - Kreb's - oxidative phosphorylation), about 36 molecules of ATP are created, giving it much more energy to use.
IN CANCER CELL:
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
introduction to WARBERG PHENOMENA:
WARBURG EFFECT Usually, cancer cells are highly glycolytic (glucose addiction) and take up more glucose than do normal cells from outside.
Otto Heinrich Warburg (; 8 October 1883 – 1 August 1970) In 1931 was awarded the Nobel Prize in Physiology for his "discovery of the nature and mode of action of the respiratory enzyme.
WARNBURG EFFECT : cancer cells under aerobic (well-oxygenated) conditions to metabolize glucose to lactate (aerobic glycolysis) is known as the Warburg effect. Warburg made the observation that tumor slices consume glucose and secrete lactate at a higher rate than normal tissues.
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.
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
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
12.
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.
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
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
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
