;    Medical Translation Insight: India to strengthen regulatory structure for medical devices - ForeignExchange Translations

India to strengthen regulatory structure for medical devices - medical translationAccording to Pharmabiz.com, Indian medical devices regulations will soon get an update. There's currently an amendment being proposed to a drug and cosmetics bill already being considered by India's parliament.

Incorporating a separate chapter in the bill for the "Import, Manufacture, Sale, Distribution and Export of Medical Devices," the proposed legislation seeks to provide comprehensive regulatory control over the medtech sector under a proposed Central Drugs Authority (CDA), which will have the authority to prescribe laws, monitor quality, and penalize violators.

The amendment is an attempt to separate medical devices in the country's regulatory framework, which so far have been treated in a similar fashion to drugs. The bill calls for creating a Medical Devices Technical Advisory Board to advise the government and CDA on technical matters.

The bill also seeks to expand the scope of the existing Drugs Consultative Committee, by renaming it the Drugs, Cosmetics and Medical Devices Consultative Committee, which would advise appropriate government bodies and the Medical Device Technical Advisory Board.

The government also hopes to appoint medical devices officers, similar to the ones currently used as drug inspectors.

Changes are happening slowly in India but they are happening.

[Via Medical Product Outsourcing]


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