Health Care :: Draft legislation to regulate medical devices ready – India

A draft legislation on regulatory framework to vallidate medical devices is ready and will be forwarded soon to Health Ministry, Science and Technology Minister Kapil Sibal said today.

“There is no mechanism or regulation in place for medical devices. The regulatory framework for medical devices is ready and we will be submitting it to the Ministry of Health soon. Hopefully it will be passed in the Parliament in a couple of sessions,” said Sibal, while inaugurating an International Conference on Medical Electronics Advancements in Products and Embedded Solutions, organised by FICCI here.

He said under the regulation the medical device will be given vallidation before they could be certified for use in India.

Sibal said his department was helped in framing the regulation by Srichitra Tirunal Institute of Medical Sciences in Kerala.

“They worked on it for two years and last week they finalised it and submitted it to us,”he said.

The minister said they would be soon giving the draft legislation to the Health Ministry. “We want a public debate on it before it is passed as a legislation,”he said.

“People everywhere want the best healthcare and don’t want any compromise on quality. But they also don’t want to spend more. It is the demand of the consumers,” he added.

Sibal said medical devices was not his sector, but as it is to do with technology, he took interest on the issue.

Providing healthcare to the poor living in the remote area should be the criteria, he said, adding it could reach them only if the medical devices are available at the lowest price.

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