Cover Story

INVITING FEEDBACK FROM INDUSTRY
FOR
DRAFT medical device regulation Bill, 2006

• Medical Device Laboratories

The MDRA shall notify Medical Device Laboratories and research institutions preferably accredited by National Accreditation Board for Testing and Calibration Laboratories, National GLP Authority or any other equivalent accreditation agency for the purposes of evaluation of medical devices under this Act.

• Risk Based Classification of Medical Device

• While classifying medical devices under the regulation, the MDRA shall bear in mind that:

1. There is complexity and wide variety requiring classification of medical devices so that the level of regulation can be proportional to the level of risk associated with them

2. The level of risk inherent in the use of a particular device depends substantially on its intended purpose and is defined by the nature or degree of contact with the human body and the duration of such contact.

• Classification of Medical Devices

The risk classification system may generally consist of four risk classes namely

i) Class A- devices involving lowest risk levels
ii) Class B- devices involving low to moderate risks
iii) Class C- devices involving moderate to high risks
iv) Class D- devices involving highest risks

• Selection and Application of Medical Device Standards

• Medical Devices Standard

In the regulations, the MDRA shall specify standards that form the basis for the conformity assessment of the medical devices. The criteria for deciding the standards are elaborated.

• Conformity Assessment And Placing On The Market

• Placing medical devices on the market

It shall be binding on manufacturers of medical devices to conform to the essential principles of safety and performance and to demonstrate conformity before placing the medical devices on the market or export from India as stipulated in this Act.

• Conformity assessment procedures

The technical documentation must allow assessment of the conformity of the product with the requirements of this Act. The Draft Bill defines the contents of the technical documentation.

MDRA shall specify in the regulations, the requirements of conformity assessment for custom medical devices and the procedure relating to medical devices for clinical investigations.

• Import Of Medical Devices

MDRA shall ensure that any medical device imported into India meets the requirements of the essential principles of safety and performance as stipulated in this Act. MDRA may, for this purpose, formulate regulations for prescribing the ways and means for ascertaining conformity.

Every manufacturer or his representative shall ensure that the medical device imported into India satisfy the requirements of this Act and rules regulations made there under, at all stages of production, processing, import, distribution and sale within the businesses under his control.

The manufacturer or his representative who wishes to import a medical device into India shall ensure that information about the manufacturer / representative is provided in such a way as to allow his identification.

If the manufacturer / representative of a medical device arranges for a label or mark to be attached or affixed to the device for the purpose of complying with Conformity declaration, labeling requirements or for any other purpose, the label must not in any way adulterate the device or obscure the information provided with the device by the manufacturer.

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