This document outlines the requirements for factory premises manufacturing medical devices according to Schedule M-III of the Drugs and Cosmetics Rules 1945 in India. It discusses location, building, water supply, waste disposal, worker hygiene and medical facilities requirements. It also provides recommendations for equipment and space needed for manufacturing common medical devices like perfusion sets, syringes and needles. Manufacturers must follow good manufacturing practices and maintain processing and quality control records. Medical devices are classified based on risk into four classes from low to high risk.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
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.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
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.
The Cometic registration and Import registration process as per regulations in India. CliniExperts Services Pvt. Ltd. provides consultation services in Cosmetic Registration since the import registration of cosmetics came into existence and became mandatory. For further assistance or queries please contact us at contact@cliniexperts.com or visit our website www.cliniexperts.com
Niosomes are vesicles composed mainly of hydrated non-ionic surfactant with or without cholesterol used for targetted drug delivery. Niosomes are better than liposomes as they are cost effective, stable, and can be stored for a long period of time.
Quality of drugs is basically responsibility of manufacturers & GMP guidelines are a means to assure very quality.
Draft of GMP regulations was prepared in 1975 which could be finalized & implemented in 1988, in form of amended schedule M.
It embraces Rule 71,74,76 & 78 under D & C Rules 1945.
To achieve objectives of GMP, licensee shall comply with requirements of GMP as laid down in Schedule M.
Part I deals with GMP relating to factory premises, & Part II deals with plant & equipment for manufacture of drugs.
Niosomes are a novel drug delivery system, in which the medication is encapsulated in a vesicle. The vesicle is composed of a bilayer of non-ionic surface active agents and hence the name niosomes.
Schedule M, M1, M2, M3 are parts of Drugs And Cosmetics Act. Schedule M to M3 Contains Good manufacturing requirements for Drugs. This are formulated to ensure that Drugs intended for human consumption and diagnosis have required safety and efficacy.
Schedule M for Pharmacy Students, Here from Pharmaceutical Jurisprudence 5th Sem.
Make easy in Student language.
Both Pharmacy Students (B Pharm & D Pharmacy
This slides contain description about SCHEDULE T good manufacturing process of Indian system of medicine contains about the process of GMP in indian system of medicine...
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
Schedule T: (Schedule T describes the Good Manufacturing Practice for Ayurvedic, Siddha and Unani Medicines.)
The Good Manufacturing Practices (GMP) are prescribed as follows:
Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination.
The manufacturing process is as has been prescribed to maintain the standards.
Adequate quality control measures are adopted.
The manufactured drug which is released for sale is of acceptable quality.
Design and Construction of plant as per the GMP Guidelines.pdfMohiniTawade
GMP is that part of Quality assurance which ensures that the products are consistently
manufactured and controlled to the Quality standards appropriate to their intended use
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...
Schedule m iii
1. BABA SAHEB BHIMRAO
AMBEDKAR UNIVERSITY
A CENTRAL UNIVERSITY
A PRESENTATION ON – SCHEDULE M-III:
REQUIREMENT OF FACTORY PREMISES FOR
MANUFACTURE OF MEDICAL DEVICES
PRESENTED BY: GUIDED BY:
MOHAMMED FAIZAN MISS GUL NAAZ FATIMA
M.PHARMA(PHARMACEUTICS)
2. Drugs & Cosmetics Rules 1945:
Schedule M-III 1. General requirements:
1.1 Location & Surroundings – The factory building and
surrounding shall be located in a sanitary place.
• Away from public lavatory, open sewage, drains, factory
producing disagreeable or obnoxious odour, fumes, soot,
smoke, dust, chemical or biological emission.
• Building shall be located away from filthy surroundings.
1.2 Buildings – The building used for the factory shall be
constructed so as to permit production under hygienic conditions.
• Not to permit entry of insects, rodents, flies, etc.
• It shall be well ventilated & clean.
• The walls of the room shall be upto a height of six feet from
the ground. 2
3. • The walls shall be smooth, water proof, & capable of being kept
clean.
• The flooring shall be smooth, even, & washable.
• The flooring shall be such so as not to permit retention or
accumulation of dust.
1.3 Water supply – The water used in manufacture shall be of potable
quality.
1.4 Disposal of waste – Suitable arrangements shall be made for
disposal of waste water.
1.5 Health clothing and sanitation of workers –
• All workers shall be free from contagious or infectious diseases.
• They shall be provided with clean uniforms, masks, handgears and
gloves seperately wherever required.
3
4. • Washing facilities shall also be provided for both the sexes
seperately.
1.6 Medical services – Adequate facilities for first aid shall be
provided.
• Regular checkup of employees shall be done.
1.7 Work benches – shall be provided for carrying out operations
such as moulding, assembling, labelling, packing etc.
• Such benches shall be fitted with smooth impervious tops.
• Shall be capable of being washed.
1.8 Adequate facilities shall be provided for cleaning, washing,
drying of different containers of devices is required.
1.9 The premises shall be kept under controlled conditions of
temperature & humidity so as to prevent any deterioration in the
properties of materials and products due to storage and process
conditions. 4
5. 2. Requirements For Manufacture Of Medical Devices:
The process of manufacture of medical devices shall be conducted at
the licensed premises, wherever required, and shall be divided into
the following seperate operations/sections:-
Moulding(wherever manufacture of medical devices is to start
from granules.)
Assembling(include cutting, washing, drying, sealing, packing,
labelling, etc.)
Raw Materials.
Storage Area.
Washing , drying & sealing area(wherever required).
Sterilization.
Testing Facilities.
5
6. The following equipment and space are recommended for the
basic manufacture of medical devices such as –
A. Sterile Disposable Perfusion and Blood Collection Sets :
1) Moulding:
• Injection moulding machine.
• Extruder machine.
• PVC Resin compounding machine.
2) Assembling :
• Hand pressing machine.
• Bag sealing machine.
6
7. • Compressor machine.
• Leak testing bench.
• PVC Tube cutting machine.
• Tube winding machine.
• Welding machine
An area of 30 square meters for moulding and 15 square meter
for assembling are recommended for basic installation. The
assembling area shall be air-conditioned provided with HEPA
filters.
7
10. 3. Raw Material : The licensee shall keep an inventory of
all raw material to be used at any stage of manufacturing
devices and shall maintain records as per Schedule U.
• All such raw material shall be identified and assigned
control reference numbers.
• They shall be conspicuously labelled indicating the name of
the material, control reference number, name of the
manufacturer and be specially labelled “Under test” or
“Approved” or “Rejected”.
• The under test, approved, or rejected materials shall
appropriately be segregated.
• A minimum area of 10 square meter shall be provided for
storage of raw materials.
10
11. 4. Storage Area : The licensee shall provide separate
storage facilities for quarantine and sterilized products.
• An area of not less than 10 square meter shall be provided
for each of them.
5. Washing, drying and sealing area : The licensee
shall provide adequate equipments like water distillation
still, deionizer, washing machine, drying oven with trays,
for washing, drying and sealing of medical devices.
• An area not less than 10 square meter shall be provided.
6. Sterilization : The licensee shall provide requisite
equipments for sterilization of medical devices by
Ethylene Oxide gas, ionizing radiation, etc.
11
12. 7. Testing Facilities : The licensee shall provide testing
laboratory for carrying out chemical or physico-chemical testing
of medical devices and raw materials used in its own premises.
Provided that the licensing authority shall permit the licensee in
the initial stage to carry out testing of sterility, pyrogens, toxicity
on their products.
8. Records : The licensee shall maintain the records of
different manufacturing activities with regard to each stage
of manufacture in-process controls, assembling, packing,
batch records for the quantity of devices manufactured from
each lot of blended granules, duration of work.
12
13. All application for manufacture of devices shall be made in
accordance of rule 76, but in case of inspection & other
requirements Schedule M-III will apply.
1. GENERAL DEFINITION: For the purposes of this
schedule any instrument, apparatus, implement, machine,
appliance, implant, in-vitro reagent or calibrator, software,
material or other similar or related article shall be deemed to
be a device under the meaning, which is :
a) Intended by the manufacturer to be used alone or in
combination for one or more specific purposes of ;
• Diagnosis, prevention, monitoring, treatment of disease.
• Diagnosis, monitoring, treatment, alleviation of or
compensation for an injury.
13
14. • Investigation, replacement, modification or support of the
anatomy or of a physiological process
• Supporting or sustaining life
• Control of conception
• Disinfection of medical devices
• Providing information for medical or diagnostic purposes by
means of in-vitro examination of specimens derived from the
human body.
RELATED TERMINOLOGIES :
The definition of a devices for “in-vitro examination”
includes- reagents, calibrators, sample collection and storage
devices, control materials and related instruments or
apparatus.
14
15. “Accessory” means an article which whilst not being a device
is intended by its manufacturer to be used together with a
device to enable it to be used in accordance with the use of the
device intended by the manufacturer of the device.
“In-vitro diagnostic medical device” means any medical
device which is a reagent, calibrator, control material, kit,
instrument, apparatus, equipment or system, whether used
alone or in combination, intended to be used in in-vitro
examination of specimens, including blood & tissue donation
from the human body, solely or principally for the purpose of
providing information:
a. Concerning a physiological or pathological state, or
b. Concerning a congenital abnormality, or
c. To monitor therapeutic measures.
15
16. “Active medical device” is any medical device, operation of
which depends on a source of electrical energy or any source
of power other than that directly generated by the human body
or gravity and which acts by converting this energy.
“Active therapeutic device” is any active medical device,
whether used alone or in combination with other medical
devices, to support, modify, replace, or restore biological
functions or structures with a view to treatment or alleviation
of an illness, injury or handicap.
“Active device intended for diagnosis” is any active medical
device, whether used alone or in combination with other
medical devices, to supply information for detecting,
diagnosis, monitoring or to support in treating physiological
conditions, states of health, illness or congenital deformities.
16
17. Classification for medical devices:
CLASS RISK LEVEL DEVICE EXAMPLES
A Low risk Thermometer/tongue
depressor
B Low-moderate risk Hypodermic
needles/suction equipment
C Moderate-high risk Lung ventilator/bone
fixation plate
D High risk Heart valves/implantable
defibrillator.
17
18. Requirements for sale of medical devices:
For the purpose of this schedule, compliance with the essential
requirements shall be presumed in respect of devices when the
manufacturer relies on latest BIS standards or ISO standards or
any other official standards or the manufacturers own validated
standards.
It is necessary for the purpose of the conformity assessment
procedures, to group the devices into four product classes :
Class A : The conformity assessment procedure for class A devices
can be carried out under the sole responsibility of the manufacturer
in view of the low level of vulnerability associated with these
products.
18
19. The manufacturers are not required to obtain manufacturing
license from Central Licensing Authority (CLAA). The
manufacturer shall register with the CLAA.
Class B : A notified body should assess and certify the
manufacturing facility quality management system. Based on the
assessment by notified body CLAA shall have no objection to
manufacture such devices. The manufacturer shall register with
the CLAA.
Class C : Devices falling under Class C constitute a medium high
risk potential, certification by a notified body is required with
regard to the design and manufacture of the devices. The
manufacturers are required to apply for a license along with
supportive documents with respect to safety & effectiveness of
these devices to CLAA.
19
20. Based on these documents & certificate issued by the notified
body, the manufacturing license will be issued by CLAA.
Class D : Devices falling under Class D constitute a high risk
potential, certification by a notified body is required with regard
to the design and manufacture of the devices.
The manufacturers are required to apply for a license along with
supportive documents in respect of safety and effectiveness of
these devices to CLAA.
The manufacturing facility will also be inspected jointly by
CLAA and state licensing authority.
Based on the recommendations of joint inspection reports and the
certification by the notified body, the manufacturing license will
be issued by CLAA.
20
21. Fees required to be paid for obtaining a license in this schedule
shall be as specified in relevant Drug & Cosmetics Act rules.
Medical devices sold in this country should, bear the ICAC mark
(Indian Conformity Assessment Certificate) to indicate their
conformity with the provisions of this schedule to enable them to
move freely within the country and to be put into service in
accordance with their intended purpose.
Wherever possible sampling of a medical device shall be carried
out in accordance of the procedure laid down in Drugs &
Cosmetics Act, 1940.
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22. Post-Marketing Surveillance & Adverse
Event (Vigilance) Reporting :
Once a medical device is placed on the market in India, the
manufacturer shall adhere to requirements of post-marketing
surveillance (PMS) to systematically monitor the performance
of the device during use.
Medical device manufacturer should comply with post-marketing
surveillance and vigilance reporting guidance.
In addition, the manufacturer should submit to CLAA vigilance
reports for analysis. The manufacturer shall follow the
procedure referred to in Annex XII in respect of Adverse Event
Reporting.
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23. Indian Conformity Assessment Certificate
(ICAC) :
Devices, other than devices which are custom-made or intended
for clinical investigations, considered to meet the essential
requirements referred to in Rule 3 must bear the ICAC marking
of conformity when they are placed on the market.
The ICAC marking of conformity, consisting of the initials ‘IC’
must appear in a visible, legible and indelible form on its
packaging, where practicable and appropriate, and on the
instructions for use.
The various components of the ‘IC’ marking must be vertical,
and may not be less than 5mm in height.
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