BABA SAHEB BHIMRAO AMBEDKAR UNIVERSITY

A CENTRAL UNIVERSITY

A PRESENTATION ON – SCHEDULE M-III:REQUIREMENT OF FACTORY PREMISES FOR

MANUFACTURE OF MEDICAL DEVICESPRESENTED BY: GUIDED BY:

MOHAMMED FAIZAN MISS GUL NAAZ FATIMA

M.PHARMA(PHARMACEUTICS)

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

• 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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• 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

2. Requirements For Manufacture Of Medical Devices:

The process of manufacture of medical devices shall be conducted atthe licensed premises, wherever required, and shall be divided intothe following seperate operations/sections:-

Moulding(wherever manufacture of medical devices is to startfrom 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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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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• 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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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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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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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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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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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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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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• 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

“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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“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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Classification for medical devices:

CLASS RISK LEVEL DEVICE EXAMPLES

A Low risk Thermometer/tonguedepressor

B Low-moderate risk Hypodermicneedles/suction equipment

C Moderate-high risk Lung ventilator/bonefixation plate

D High risk Heart valves/implantabledefibrillator.

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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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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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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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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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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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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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