Indian DTAB recommends strict implementation of ICAC mark for medical devices sold on Indian market

India has finalized the guidelines to the manufacture, import and sale of medical devices under Schedule M III.

The Drug Technical Advisory Board (DTAB) in India has recommended strict implementation of Indian Conformity Assessment Certificate (ICAC) for the medical devices manufactured, imported and marketed on Indian market.

Schedule M-III
REQUIREMENTS FOR THE MANUFACTURE, IMPORT AND SALE OF MEDICAL DEVICES
(Final Draft –DTAB, Date: 23rd Feb 2009)

India has finalized the guidelines to the manufacture, import and sale of medical devices under Schedule M III.

The Drugs Technical Advisory Board (DTAB) which provides technical guidance to the Central Drugs Standard Control Organization under the ministry of Health and Family Welfare has submitted the final draft of the guidelines on medical devices.

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 Schedule M III.

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.

Classification

Medical Devices shall be classified as per their risk level and intended use . They shall be divided into Classes A, B, C, D. Classification shall be carried out in accordance with Annex IX.

The classification rules set out in Annex IX may be adapted by CLAA in accordance in the light of technical progress and any information which becomes available under the information system provided for in 10. ( Information on incidents occurring following placing of devices on the market) Whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices;

Risk Level
Medical Devices shall be classified as per the Figure 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.
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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

Placing on the market and putting into service

Conformity assessment procedures

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.

For Class B devices, 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 device(s). Class B device manufacturers shall register with the CLAA.

For device(s) falling under Class C which constitute 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.

For devices falling under Class D which 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 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.

ICAC mark

Medical devices sold in India should, as a general rule, 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 devices shall be carried out in accordance of the procedure laid down in Drugs and Cosmetics Act, 1940. In case the nature of the devices is such that above procedure cannot be adopted, CLAA may take samples for evaluation from experts in the field or take any other measure to verify the claim of the manufacturer.

Essential requirements

The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.

Post-Marketing Surveillance and 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. As appropriate, events meeting certain criteria should be analyzed and reported to a designated authority (“vigilance reports”). As part of the manufacturer’s Quality Management System, appropriate corrective and preventive actions may be applied to prevent the recurrence of adverse events. Medical device manufacturers should comply with post-marketing surveillance and vigilance reporting guidance provided hereinafter. 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.

Free movement, devices intended for special purposes

CLAA shall not create any obstacle to
the placing on the market or the putting into service within the country devices bearing the ICAC marking provided for in ICAC marking which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Conformity Assessment procedure (11)

Note : It should be understood the requirement to bear the ICAC mark also applies to devices in Classes A and B (which do not require conformity assessment by a Notified Body.

CLAA shall not create any obstacle to
Devices intended for clinical investigation being made available to medical practitioners or authorized persons for that purpose if they meet the conditions laid down in Clinical Investigation (14) and in Declaration of Conformity (Annex VII ) and bear form12 License under D&C Act.

Custom-made devices being placed on the market and put into service if they meet the conditions laid down; Class B, C and D devices shall be accompanied by the statement, which shall be available to the particular patient or user identified by name, an acronym or a numerical code.

The following devices may not bear the ICAC marking:
At trade fairs, exhibitions, demonstrations, etc. there shall not be any obstacle to the showing of devices which do not conform to this Schedule, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply and the manufacturer has permission under appropriate Rules of the D&C Act.

Standards

In order for the manufacturer to demonstrate conformity with the relevant regulatory requirements, the CLAA shall adopt and recognize BIS 15575 or its revisions and ISO 13485 in respect of the specifications to be followed for Quality Management Systems.

For the purposes of this Schedule, reference to harmonized standards also includes the monographs of the Indian Pharmacopoeia and US, EU pharmacopoeia wherever applicable, notably on surgical sutures and on combination of pharmaceutical and devices.

Labelling

The packaging of medical devices shall be labelled as per the Annex XIII and relevant ISO standards.

Additionally relevant internationally accepted symbols denoting sterilization, single use etc, as per ISO 15223-1:2007 shall also be depicted.

Note 1: Medical Devices shall be exempted from mentioning Date of manufacture in labelling.

Note 2: In case of medical devices sold in bulk packaging without any primary packaging, labelling shall be on the bulk package.

Note 3: In case of Medical Devices imported to the country, the importer can take permission for further labelling of the package under provision of Rule 104A of the drugs and cosmetic rules from the CLAA before release for sale in the market.

Note 4: The rules for labelling specified as per Rule 109A shall not be applicable to medical devices

Shelf Life: In special circumstances to be mentioned in writing and permission taken thereof from the CLAA, shelf life of imported medical devices may not be covered under Rule 31 of the D&C Rules.

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. Where applicable, the ICAC marking must also appear on the sales packaging.

The various components of the ‘IC’ marking must be vertical, and may not be less than 5mm in height.

It shall be accompanied by the identification number of the notified body issued by CLAA responsible for implementation of the procedures set out in Annexes II, IV, V and VI.
It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the ICAC marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the ICAC marking is not thereby reduced.

Wrongly affixed ICAC marking

(a) where CLAA establishes that the ICAC marking has been affixed unduly or is missing in violation of the Schedule M III, the manufacturer or his authorized representative shall be obliged to end the infringement under conditions imposed by the CLAA;

(b) where non-compliance continues, the CLAA must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in this Schedule. (No 9).

Those provisions shall also apply where the ICAC marking has been affixed in accordance with the procedures in this Schedule M III, but inappropriately, on products that are not covered by this Schedule M III.

Indian Conformity Assessment Certificate (ICAC) mark