The Indian Trade Regulatory Authority allows the issuance of export certificates for EPC medical devices

In a bid to ensure uninterrupted exports of medical devices and streamline customs processes, the Directorate General of Foreign Trade (DGFT) under the Union Ministry of Commerce and Industry has issued a directive allowing the Medical Devices Export Promotion Council to issue registration documents – Membership Certificates (RCMC).

Medical device manufacturers can currently be members of various Export Promotion Councils (EPCs) such as Engineering Export Promotion Council (EEPC), Pharmaceutical Export Promotion Council of India (Pharmexcil) and Federation of Indian Export Organizations (FIEO). They can obtain RCMC from any of these EPCs.

The new directive now also includes the EPC for medical devices as the authority authorized to issue RCMCs. Previously, the Medical Devices EPC could not issue RCMCs because it was not operational. “Now that the system is operational, the government is announcing a transition system that will ensure that once the Medical Devices EPC is staffed and fully operational, it will take over the role of issuing RCMCs for medical device exporters,” a senior government official said.

This directive, detailed in a public notice dated June 23, 2023, addresses key challenges that hinder medical device exporters from obtaining RCMCs critical to enjoying export benefits under the Remission of Duties and Taxes on Exported Products Program (RODTEP).

The highlight of the new directive is the inclusion of the Export Promotion Council (EPC) for Medical Devices in Annex 2T of the Foreign Trade Policy (FTP) 2023, which empowers the EPC for Medical Devices to issue RCMCs for specific products, providing additional streamlining to existing equipment. Importantly, RCMC certificates issued by the Engineering Export Promotion Council of India (EEPC India) will remain valid until their scheduled expiry, ensuring continuity during the transition period, the directive reviewed by Business Today pointed out.

However, despite this forward-looking measure, the EPC card for medical devices is not yet fully operational or integrated with the DGFT common digital platform for the issuance of RCMC, creating temporary logistical challenges for exporters.

To circumvent these issues, the DGFT has provisionally authorized EEPC India and other relevant EPCs to continue issuing RCMCs for medical devices. This pragmatic temporary solution aims to alleviate delays and ensure that exporters can quickly obtain the necessary certificates to clear customs and export benefits.

EEPC India, a leading trade and investment promotion organization in the engineering sector, is well-placed to provide assistance given its extensive membership of over 12,000 people, including numerous SMEs. Customs authorities have been directed to accept RCMCs issued by EEPC India and other relevant EPCs until the EPC for medical devices is fully functional, the official said.

The Association of Indian Medical Devices Industry (AIMED) is championing this initiative to strengthen the Indian brand’s global presence and offer sector-specific focus and support to Indian manufacturers. “The DGFT’s action is welcome as it addresses the challenges of the transition until the Medical Devices EPC becomes fully operational. As outlined in the National Policy on Medical Devices 2023, the Medical Devices FTE plays a key role among six key strategies to make India a medical device manufacturing hub,” said Rajiv Nath, Coordinator, AIMED Forum.

“In the Indian medical device industry, exports have increased significantly, reaching approximately USD 668.9 million in 2022-23, an increase of 65%. This ranks India after Germany and China in terms of export volume, highlighting the industry’s commitment to quality and emerging global leadership,” said Rajiv Chhibber, Vice President, External Affairs, Sahajanand Medical Technologies Ltd on the sidelines of the inaugural edition of India Health Expo, organized by Informa Markets in India.

“India’s medical device industry, currently valued at $11 billion (Rs 91,300 crore), is growing at an annual rate of 18-20%, highlighting its rapid growth and global competitiveness. It is expected to reach $50 billion (Rs 4,150,000 crore) by the year. by 2030 and over $250 billion (Rs 20,750,000 crore) by 2047.” Chhibber said.