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.
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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.
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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.
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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.
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8. B. Sterile Disposable Hypodermic Syringes :
1) Moulding :
• Granulator
• Injection moulding machine
• Weighing devices
2) Assembling :
• Blister pack machine
• Vaccum dust cleaner
• Rubber-tip washing machine
• Foil stamping or screen printing equipment.
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9. C. Sterile Disposable Hypodermic Needles :
1. Moulding :
• Needle grinding and levelling machine.
• Electro polishing machine.
• Cutting machine.
• Injection moulding machine.
• Air-compressor.
2. Assembling :
• Needle cleaning machine.
• Blister packing machine.
• Needle inspection unit.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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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