The medical devices industry has approached the Central government to create a Medical Devices Advisory Board to have a proper policy and regulations to govern the sector.

Currently medical devices industry is not coming under the regulatory umbrella of any particular ministry or department of the Centre. The All India Syringes and Needles Manufacturers Association has urged the Government to set up the Board to give a concrete direction to the growing industry. The association has called for periodical training and competency assessment exercise for the inspectors of the state drug authorities to bring in uniformity at the national level.

The medical devices are very different from pharmaceutical products, in the terms that the pharmaceutical  products of the same terminology may have different doses with different formulae. However, the medical devices under a product family are of similar in nature, except for the size, gauge and length combinations.

As per the existing guidelines, the product families of medical devices are treated as one product rather than different products and for each size. However, some state authorities were having different interpretations and treat products of the same family as different individual products.  They also objected to the existing practice of getting separate permissions from the authorities for manufacturing one item in more than one brand.