Medical devices are considered to be life saving products like drugs as many of them are implanted into the human body for critical care. These are usually expensive products and have to be recommended by the medical practitioners. Implanting of a poor quality or defective device can cost the very life of the patient and that necessitates certain minimum government standards for these products. Yet, almost all of these products numbering over 14,000, remained outside the regulatory umbrella of the country for years. Only in 2005, ten of these products like cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants, and internal prosthetic replacements brought under the purview of Drugs & Cosmetics Act, making it mandatory to get licenses for their manufacture, sale and distribution. Since then, the government has been debating with the Union ministry of health and Department of Science & Technology how to lay down a set of rules and bring an authority to govern this sector. The industry has also been demanding a separate definition and guidelines for medical devices, which are currently being classified as drugs. Broadly the designated authority with adequate powers can ensure standards, efficacy, safety and availability of medical devices manufactured or marketed in the country. It could also develop a system of classification of devices, notify standards and guidelines from time to time, provide a mechanism for conformity assessment using direct or third party notified bodies and stipulate the procedure and guidelines for testing laboratories. But, the Centre has not been able to come to a decision on the matter during the last four years as there has been tussle between the Health Ministry and Department of S&T regarding who will regulate the sector. Both the Health Ministry and the Department of S&T had prepared separate draft bills for regulating these products and establishing an authority to control the industry. Finally the whole confusion seems to have ended now with the intervention of the Prime Minister’s office last week. The PM’s office has entrusted the responsibility of regulating the sector with the health ministry and notification is expected to be issued by June 2010. The Health Ministry has been, however, asked to consult and study the draft document prepared by the Department of S&T and incorporate relevant inputs from it in the draft bill prepared by Health Ministry. It is important to have expert advice of the Department of S&T on the technical and quality aspects of medical devices but it is only appropriate to have regulatory control of the sector with the Health Ministry as these products are used for medical emergencies by the medical practitioners.