New Delhi, June 12, 2024 – The Directorate General of Foreign Trade (DGFT) under the Ministry of Commerce and Industry has issued Trade Notice No. 05/2024-25, mandating a significant update regarding the Registration-Cum-Membership Certificate (RCMC) for medical devices. This directive is important for medical device manufacturers and importers, ensuring streamlined compliance with the regulatory framework. The DGFT has reiterated its directive from Public Notice No. 18/2023 (June 23, 2023), stating that the Export Promotion Council (EPC) for India (EPC India) is the sole authority for issuing RCMCs for medical devices. This measure aims to eliminate confusion and ensure uniform handling of all RCMC issuances by EPC India.
Mandatory RCMC for RoDTEP Benefits
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 has faced difficulties in securing RCMCs and clearing goods at customs points due to these requirements. This latest directive aims to resolve such issues by clarifying the exclusive role of EPC India. Medical device manufacturers and importers holding RCMCs issued by other EPCs are advised to revalidate their certificates through EPC India, with the validity of such certificates extending until their expiry date. Addressing inconsistencies noted in prior DGFT communications, the trade notice clarifies the exclusive role of EPC India in handling RCMC applications for medical devices. This is intended to streamline processes and enhance regulatory clarity.
Customs Compliance
Customs authorities are instructed to recognize only those RCMCs issued by EPC India for medical devices, which is crucial for ensuring compliance during import and export procedures. Stakeholders are advised to stay updated with any future communications from the DGFT or EPC India regarding RCMC issuance.
Conclusion
This development underscores the importance of compliance with DGFT regulations for medical device manufacturers and importers. Ensuring that RCMCs are obtained exclusively through EPC India will be critical for maintaining smooth operations and avoiding any disruptions in trade. For medical device manufacturers and importers navigating these regulatory changes, Morulaa offers comprehensive support to ensure seamless compliance with CDSCO and DGFT requirements. Our expertise includes assisting in the RCMC application process, ensuring all necessary documentation is accurately prepared, and liaising with EPC India to expedite certification. By partnering with Morulaa, businesses can confidently manage their regulatory obligations and focus on their core operations. For further information on how Morulaa can assist with RCMC for medical devices and CDSCO compliance, visit Morulaa HealthTech.