The Centre has initiated a dialogue with certification organisations including UL India Private Limited, an affiliate of the US-based Underwriters Laboratories Inc, for appointing an authorised certification company for Indian medical devices.

The discussion is a sequel to the Central Government’s decision to make it mandatory for all companies to have their medical devices certified.

The current global trend is that regulatory agencies in the US, Canada and Japan are authorising third party associates to act on their behalf with regard to product safety testing and certification. India is viewed as an emerging market with a lot of potential and UL is gearing up to support medical devices manufacturers in the country, Anil N Patel, director, Medical, Underwriters Laboratories Inc. who was in India, told Pharmabiz.

UL officials did not disclose information on the outcome of discussions with government of India. Patel said, “We are focussing on India to help the medical device manufacturing companies achieve global acceptance of their products and processes.”

With the Central Government passing stringent orders on registration and certification of medical devices, manufacturers in India are looking to have their range of medical products notified. With UL being an authorised service provider of regulatory authorities in the US, Canada, Europe and Japan it can handle any size of operations.

“The company’s Medical Devices Centre of Excellence located in Bangalore is aggressively chalking out a plan to start accessing companies located in Australia, South Asia and South Africa with India as a base. Stepping up level of quality systems, consistency and market sampling in the area of medical devices would be the key focus areas,” stated Patel.

The facility, which currently has strength of 110, including an audit team of six members to address any product safety and certification assignments, will increase its manpower to 150 by the end of 2006 informed R.A. Venkitachalam, managing director, UL India.