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Medical devices manufacturing guidelines finalized in India

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Tuesday, June 30, 2009, 18:58 This news item was posted in medical devices category and has 0 Comments so far.

ICAC mark to be made mandatory as quality benchmark of medical devices sold in India.

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 – the apex body to regulate drugs and cosmetics – under the ministry of Health and Family Welfare has submitted the final draft of the guidelines on medical devices to the drug controller.

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 of  medical devices

As per the new guidelines medical devices will be categorized into four classes –A,B,C, D as per their risk level and intended use.

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. Low risk devices and equipment such as thermometers / tongue depressors will come under class A. Low to moderate risk devices including hypodermic needles / suction equipment will belong to class B. Class C will comprise moderate to high risk equipment like lung ventilator / bone fixation plate etc. While high risk devices such as heart valves, implantable defibrillator etc would be under class D.

Regulatory requirement for the devices will be higher in accordance with the increasing risk. The  regulatory controls may include:  operation of a quality system (recommended for all devices); technical data; product testing using in-house or independent resources;  documentation of clinical evidence to support the manufacturer’s claims;  the need for and frequency of independent external audit of the manufacturer’s quality system and independent external review of the manufacturer’s technical data.

The classification rules will be adapted CLAA. CLAA will review each and every device specification in view of the diverse nature of the devices and technological progress in this field, and classify or re-classify the products.

If a manufacturer desires to reclassify a device to a lower class, it must submit justification to the CLAA for evaluation that less stringent class requirement will assure sufficient safety and effectiveness of the device.

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 devices may have to comply with all required norms including clinical investigations.

For the purpose of carrying out the clinical investigations, appropriate means have to be specified for the protection of public health and public order.

For devices falling within Class D and implantable and long term invasive devices falling within Class B or C, the manufacturer may commence the relevant clinical investigation after obtaining approval from CLAA.

The assessment of conformity of devices with the quality requirement will be done by the CLAA in consultation with the BIS or any other such competent body.

Clinical investigations

In the case of devices other than D, C and B  CLAA may authorize manufacturers to commence clinical investigations immediately after the date of information and submission to CLAA, provided that the ethics committee concerned has issued a favourable opinion on the program of investigation in question including its review of the clinical investigation plan.

The manufacturer will have to notify the CLAA of the end of the clinical investigation, with a justification in case of early termination.

Pharmacovigilance

Once a medical device reaches the market in India, the manufacturer will have to adhere to requirements of post-marketing surveillance (PMS) to systematically monitor the performance of the device during use.

Medical device manufacturers are required to comply with post-marketing surveillance and vigilance reporting guidance provided. In addition, the manufacturer should submit to CLAA vigilance reports for analysis as per the stipulated procedure.

Adverse events that result in unanticipated death or serious injury or represent a serious public health threat must be reported by the manufacturer within 48 hours.

All other reportable events must be reported as soon as possible by the manufacturer, but not later than 30-elapsed calendar days following the date of awareness of the event.

Medical devices: Quality standards

CLAA will adopt and recognize BIS 15575 or its revisions and ISO 13485 in respect of the specifications to be followed for quality in order for the manufacturer to demonstrate conformity with the relevant regulatory requirements.

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.

Medical devices: Labelling

The packaging of medical devices will have to be labelled as per the relevant ISO standards. Additionally relevant internationally accepted symbols denoting sterilization, single use etc, as per ISO 15223-1:2007shall also be depicted.

However, medical devices will be exempted from mentioning date of manufacture in labeling, in case of medical devices sold in bulk packaging without any primary packaging. Here the labelling shall be on the bulk package.

Imported medical devices

For the imported medical devices, 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. The rules for labelling specified as per Rule 109A shall not be applicable to medical devices.

As far as the imported devices the label are concerned, the outer packaging, or instructions for use, should contain in addition the name and address of either the authorized agent responsible or of the authorized representative of the manufacturer established within the country or of the importer established within the country. Shelf life of imported medical devices may not be covered under Rule 31 of the D&C Rules for devices imported into the country.

An expert committee consisting of experts of relevant fields of the devices constituted by the Government shall assist CLAA in evaluation of application of devices.

ICAC Mark of quality

According to the new guidance, all medical devices sold in this country should carry 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.

The conformity assessment procedures for Class A devices can be carried out 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 should register with the CLAA. For Class B devices, a notified body should assess and certify the manufacturing facility quality management system. Class B device manufacturers should register with the CLAA. For device falling under Class C which constitute a medium high risk

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 supportive documents with respect to safety and effectiveness of these devises 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 the manufacturing license will be issued by CLAA.

For devices falling within Class B, other than devices which are custom-made or intended for clinical investigations, the manufacturer will, in order to affix the ICAC marking, follow the procedure relating to the ICAC declaration of conformity.

For devices falling within Class A, other than devices which are custom-made or intended for clinical investigations, the manufacturer will have to, in order to affix the ICAC marking, follow the procedure referred and draw up the ICAC declaration of conformity required before placing the device on the market.

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