Requirements For The Regulatory Control Of Medical Devices In India

In India import, manufacturing, sale and distribution of Medical devices is regulated under Drugs and Cosmetics Act and Rules. At present, Medical Devices notified by Central Government are regulated under the said Act. List of notified medical devices is available on...

Medical Devices Industry Welcomes DCGI’s Regulatory Guidance

The Association of Indian Medical Devices Industry (AIMED) has welcomed the new set of draft regulatory guidance issued by the Drug Controller General of India (DCGI) for medical devices segment. The regulatory guidance will prove to be a good beginning to address the issues in medical devices industry...

Guj FDCA To Get Support From US FDA Office In Medical Devices Regulation

The Gujarat state Food and Drug Control Administration (FDCA), which has initiated efforts to achieve expertise and facilities to effectively monitor and regulate the medical devices industry, is expected to receive tips from the US Food and Drug Control Administration (US FDCA) on the latest technology developments in the segment, it is learnt...

Union Govt May Lay Down Standards For Medical Face Masks Soon

Union government is working on to lay down a set of standards for medical face masks manufactured in the country and for imported ones soon. The need for a standard format comes is important with the onset of the second virulent wave of H1N1 flu. In the absence of a Medical Face Masks Association, Thea-Tex Healthcare (India) Pvt Ltd a leading manufacturer of high quality masks has provided its recommendations to model a standard on the European Surgical Mask format of EN14683...

Armor Plast Mulls Capacity Expansion At Rs 14 cr, Seek Tie Ups With Global Medical Device Majors

Armor Plast Ltd an integrated supplier of high-end medical engineering devices, has chalked out a Rs 14 crore investment plan to augment production capacity to introduce a range of new products. Going by the market potential for growth in medical engineering space and the need for high quality disposable devices, Armor has chalked its expansion plan to respond to the market opportunities and set new standards of efficiency...

Bilcare Completes Acquisition Of Plastic Film Making Unit Of INEOS

Indian pharmaceutical product packaging company Bilcare has completed a Rs 607-crore acquisition of the plastic film-making unit of petrochemical company INEOS, the company’s chairman said...