Export Promotion Council for Medical Devices (EPCMD) - RCMC Registration, Fees & Process

Following documents must be submitted for EPCMD RCMC registration:

• IEC Certificate
• Certificate of Incorporation / Registration Certificate
• MOA & AOA (for companies)
• GST Registration Certificate
• Bank Certificate / Cancelled Cheque
• CDSCO Registration / License (for regulated medical devices)
• Product list with HS codes
• PAN Card
• Board Resolution (for companies)
• Digital Signature Certificate (DSC) for online portal submission

Note: EPCMD RCMC applications are submitted through the DGFT Trade Portal (dgft.gov.in) using the applicant's DSC and IEC-linked profile.

EPCMD commonly referred to as Export Promotion Council for Medical Devices is a non-profit organization registered under the Companies Act and constituted by the Ministry of Commerce and Industry to promote export of medical devices from India. Established under the administrative control of the Department of Pharmaceuticals, EPCMD serves as the nodal body connecting Indian medical device manufacturers and exporters with international markets.

The mandate of EPCMD covers the following functions:

• Issuance of Registration Cum Membership Certificate (RCMC) to eligible medical device exporters for availing benefits under the Foreign Trade Policy (FTP)
• Market development and promotional activities for Indian medical device exporters in international markets
• Organizing and participating in international trade fairs, exhibitions, and buyer-seller meets
• Liaising with foreign governments, international buyers, and regulatory bodies to facilitate market access for Indian medical devices
• Providing market intelligence, trade data, and regulatory guidance to member exporters
• Policy advocacy with the Ministry of Commerce and Industry on behalf of the medical devices export sector

Indian exporters of medical devices need to deal with two different regulatory agencies, each playing its own unique role

• CDSCO (Central Drugs Standard Control Organization) under the Ministry of Health and Family Welfare regulates the quality, safety, and performance of medical devices for manufacture, import, and domestic sale in India under the Medical Devices Rules, 2017. CDSCO registration or license is a product-level requirement
• EPCMD, on the other hand, operates under the Ministry of Commerce and Industry and focuses exclusively on export promotion. RCMC issued by EPCMD is an exporter-level registration that enables the exporter to avail FTP incentives

RCMC (Registration –Cum-Membership-Certificate) is a mandatory document for Indian exporters seeking to get benefits under the Foreign Trade Policy. EPCMD RCMC acts as official proof that an Indian exporter is registered with the government-authorized council for medical devices. RCMC is an official membership card that makes way for the exporter to access government benefit schemes and helps build credibility in global trade. A valid EPCMD RCMC enables exporters to claim duty exemptions under Advance Authorization, participate in EPCMD-organized international trade fairs, and register as a verified Indian medical device exporter on global buyer platforms.

Business Needs RCMC Certification Because:

• An RCMC certificate is mandatory for Indian exporters to avail benefits of government provided export benefits and schemes in India
• The certificate builds credibility with buyers and creates an official record of export operation
• RCMC is mandatory to receive benefits of RoDTEP, duty drawback, advance authorization, EPCG, and LUT for exporting without the need to pay IGST
• Certificate helps in ensuring an efficient customs clearance process by validating exporter's identity
• Using the Export Promotion Councils (EPCs) reduces delays and leads to fewer inspections of goods as well as facilitating the release of regulated and restricted items
• Exporters with RCMC certificate can participate in international trade exhibitions, trade fairs and buyer/seller meets organized by EPCs
• RCMC registration and renewal process is smooth and hassle-free with easy-to-follow procedures through the official DGFT portal

RCMC issued by the Export Promotion Council for Medical Devices is generally valid for 5 financial years from the date of issuance. An annual membership fee must be paid to maintain this validity. The EPCMD renewal application must be submitted online through the DGFT Common digital platform. RCMC must be renewed before expiry to maintain uninterrupted access to foreign trade policy benefits.

EPCMD issues RCMC for medical devices and related healthcare equipment across multiple product categories formally notified under DGFT Public Notice No. 18/2023 dated 23rd June 2023. These are the items listed under Entry No. 38 of Appendix 2T of the Foreign Trade Policy 2023, authorizing EPCMD to issue RCMC for specific medical device items with immediate effect. The relevant ITC (HS) code must be selected from the notified list while filing the e-RCMC application on the DGFT Trade Portal.

Not all health and wellness products fall under the jurisdiction of EPCMD products list India. The following categories are specifically excluded:

• Pharmaceutical drugs and medicines: Exporters of pharmaceutical products must obtain RCMC from PHARMEXCIL (Pharmaceuticals Export Promotion Council of India)
• Ayurvedic, Unani, Siddha, Yoga, and Homeopathy products: Exporters of AYUSH products must obtain RCMC from AYUSHEXCIL (Ayush Export Promotion Council)
• Borderline products: Certain products that overlap between medical devices and cosmetics, wellness products, or food supplements may require a product classification clarifi

The Export Promotion Council for Medical Devices (EPCMD) accepts RCMC applications from the following categories of exporters engaged in the medical devices sector:

• Manufacturer Exporter A business entity that manufactures medical devices in India and directly exports them to international markets.
• Merchant cum Manufacturer Exporter A business entity that both manufactures and trades in medical devices, engaging in export activities either directly from its own manufacturing unit or through third-party procurement.
• Merchant Exporter A trading entity that purchases medical devices from Indian manufacturers and exports them without engaging in manufacturing activity itself.
• Service Provider Entities that provide specialized services to the medical devices export ecosystem, including testing laboratories, calibration bodies, certification agencies, regulatory consultants, and quality assurance service providers are also eligible to obtain EPCMD RCMC under the Service Provider category.

Note: For manufacturers and importers dealing in regulated medical devices, a valid manufacturing license or import registration under the Medical Devices Rules, 2017 issued by the Central Drugs Standard Control Organization (CDSCO) is required as supporting documentation for the RCMC application. For devices classified under Class A and Class B, certain categories may not require a formal CDSCO manufacturing license.

Exporters avail several benefits after securing RCMC from the Export Promotion Council for Medical Devices. EPCMD benefits are listed below:

• Access to Foreign Trade Policy (FTP) Export Incentives: A valid EPCMD RCMC is the gateway to key FTP export incentives for medical device exporters in India.
• Market Access Initiative (MAI) Scheme Funding: EPCMD members are eligible to apply for financial assistance under the Market Access Initiative (MAI) scheme of the Ministry of Commerce and Industry.
• Participation in Global Medical Device Trade Fairs: EPCMD facilitates and supports Indian medical device exporters in participating in leading international trade exhibitions such as Medica (Germany), Arab Health (Dubai), and Medtrade (USA).
• Buyer-Seller Meets and Trade Delegations: The council organizes buyer-seller meets and outbound trade delegations to high-potential export markets, enabling EPCMD members to establish direct commercial relationships with overseas importers and healthcare institutions.
• Country-Specific Market Intelligence: EPCMD provides members with market intelligence reports, regulatory updates, and trade data specific to target export markets, helping exporters make informed decisions about market entry, pricing, and compliance requirements in destination countries.
• Certificate of Origin Facilitation: EPCMD assists members in obtaining Certificates of Origin for medical device shipments, required by several importing countries for customs clearance and tariff concession purposes.

Obtaining RCMC from the Export Promotion Council for Medical Devices is a critical compliance requirement for medical device exporters seeking to avail Foreign Trade Policy benefits, access institutional export promotion support, and establish credibility in international markets. The registration process involves multiple prerequisites, accurate ITC (HS) code selection, digital filing on the DGFT Trade Portal, and timely coordination with EPCMD.

Professional Utilities, with over a decade of experience in export compliance and RCMC registrations across more than 20 Export Promotion Councils, provides completes assistance for EPCMD RCMC Registration. Our experts ensure complete application assistance.