ICAC Mark – An Overview

Schedule M 111 contains guidelines to the manufacture, import and sale of medical devices in India, regulated by Drugs & Cosmetics Act and Rules. The new guidelines Schedule M III which comes as extension to the Schedule M under India's Drug and Cosmetics Act that stipulates norms for the manufacturing and sales of pharmaceutical products in the country.

The medical devices and equipment are currently notified as drugs are regulated under the Drugs & Cosmetics Act and Rules. However, the guidelines will apply to inspections and other requirements of Schedule M III.

Classification of Medical Devices:

Medical Devices shall be classified as per their risk level and intended use according to Annex 1X. They shall be divided into Classes A, B, C, D.

Medical Devices shall be classified as per the Table 1 mentioned below. The examples given are for illustration only and the classification of Medical Devices must be done as per the classification rules for each medical device according to its intended purpose as per Annex IX

Figure 1: General classification system for medical devices

CLASS
RISK LEVEL
DEVICE EXAMPLES
A
Low Risk
Thermometers / tongue depressors
B
Low-moderate Risk
Hypodermic Needles / suction equipment
C
Moderate-high Risk
Lung ventilator / bone fixation plate
D
High Risk
Heart valves / implantable defibrillator

Conformity assessment procedure:

The conformity assessment procedures for Class A devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products. The manufacturers are not required to obtain manufacturing license from Central Licensing Authority CLAA. Class A device manufacturer shall register with the CLAA.

Class B devices, a Notified Body should assess and certify the manufacturing facility and quality management system. Based on the assessment by Notified body, CLAA shall have no objection to manufacture such device(s). Class B device manufacturers shall register with the CLAA.

Class C devices, which constitutes a medium high risk potential, certification by a Notified Body is required with regard to the design and manufacture of the device(s). The manufacturers are required to apply for a license along with supportive documents with respect to safety and effectiveness of these devises to CLAA. Based on these documents and certificate issued by the Notified Body, the manufacturing license will be issued by CLAA.

Class D devices, which constitutes 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 the supportive documents in respect of safety and effectiveness of these devices to CLAA. The class D devices manufacturing facility will also be inspected jointly by CLAA and state licensing authority. Based on the recommendations of joint inspections report and the certification by the Notified Body, the manufacturing license will be issued by CLAA.

Medical Device guidance document

Schedule M 111 Guide

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