second draft of medical device regulations disappointing: industry

by:Dino     2021-08-12
The statement said they were \"absolutely disappointed\" with the second draft of the medical device regulations notified by the EU health ministry on Wednesday, which industry insiders believe will be a fatal blow to the domestic medical device industry.
The new specification requires medical device manufacturers to follow labeling requirements that are different from globally recognized standards, and the product has a shorter validity period.
\"We were very disappointed and shocked!
Rajiv Nath, coordinator of the Forum of the Indian Medical Device Manufacturers Association, said: \"Why do we work for Cross Purposes (AIMED)
Lobbying groups in the domestic medical device industry.
\"The latest draft regulation is an attack on the \'Made in India\' program.
\"The proposed regulations will legalize the pseudo-manufacturing sector, leading to the closure of domestic manufacturing and the expulsion of jobs from India,\" he added . \".
The latest regulations are seen by the domestic industry as another blow to the domestic manufacturing industry and the \"Made in India\" efforts of the medical device industry.
\"While the globally accepted standard for medical devices is a 10-year expiry date, these specifications require 5-year expiry.
This will hurt the industry a lot, \"said another source, who declined to be named.
The proposed specification will be in the public domain next month, giving the industry time to give feedback on the latest version of the notice.
The domestic medical device industry is now worried about the future viability of the domestic manufacturing industry, unless some
The mandatory terms are not revoked or corrected.
\"India\'s manufacturing sector is falling, and there is no bigger example than medical devices.
Earlier, simple equipment such as thermometers, audiologists and hot water bottles made in India had been outsourced to China.
Not only did the government lose the opportunity to bring manufacturing back to India and attract investment, but he said: \"by distorting the definition of\" manufacturer, people who will get the medical equipment that another company makes on his behalf will be included and will now legalise the pseudo-manufacturing. \"Nath.
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