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Introduction:

The Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce and Industry, has released Trade Notice No. 05/2024-25. This notice introduces an important update regarding the Registration-Cum-Membership Certificate (RCMC) for medical devices. This update is significant for the exporter of medical device.

The DGFT has announced an amendment in Appendix 2T, which lists Export Promotion Councils vide Public Notice No. 18/2023 on June 23, 2023. This amendment introduces the Export Promotion Council for Medical Devices as a new entry at Sl. No. 38 in Appendix 2T. The introduction of this council aims to simplify the process of issuing the Registration-Cum-Membership Certificate (RCMC) for the specific items outlined in the accompanying table of the notification.

Validity of Existing RCMCs Issued by EEPC India:

The new amendment ensures that all RCMCs issued by EEPC India before the release of Public Notice No. 18/2023 on June 23, 2023, will stay valid until they naturally expire. This helps businesses with existing RCMCs avoid any interruptions in their operations or eligibility for export incentives. The DGFT has emphasized that from now on, EPC for medical device is the exclusive body responsible for issuing RCMCs for medical devices, which aims to clear up any confusion and streamline the process for everyone involved.

Delay in Functionality of EPC for medical devices

One of the conditions for availing benefits under the Remission of Duties and Taxes on Exported Products (RoDTEP) scheme for medical devices is obtaining an RCMC from the concerned EPC. The industry was facing significant operational hurdles due to difficulties in securing RCMCs from EPC for medical devices since the said council is not operational properly and council is yet to the regular functional. This delay has caused significant operational challenges for the medical device industry. The inability to secure RCMCs from the newly established council has hindered the industry’s ability to clear goods at customs points effectively. In response, the DGFT has decided that, until the Export Promotion Council for Medical Devices becomes fully functional, EEPC India and any other relevant Export Promotion Councils are authorized to issue RCMCs for medical devices.

Conclusion:

By facilitating the issuance of RCMCs through existing councils and clarifying the exclusive role of EEPC India, the DGFT aims to ensure that the industry can continue to operate smoothly and benefit from export incentives, despite the delays in the operationalization of the new Export Promotion Council for Medical Devices.

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