Assistance to Medical Device Clusters for Common Facilities (AMD-CF) Scheme
AMD-CF Scheme

AMD-CF Scheme Aims to strengthen Medical Device clusters by providing financial assistance and to strengthen and / or establish more Testing Laboratories for Medical Devices to improve quality and sustainable growth

Components Of The Scheme

1. Assistance for Common Facilities (CF)

To strengthen the medical device clusters’ capacity for their sustained growth by creating Common Infrastructure Facilities.

Intended Beneficiaries

  1. Medical Devices manufacturing units in a cluster who have come together to form a Special Purpose Vehicle (SPV) to execute the project of developing common facility. There shall be a minimum of 5 Medical Device manufacturing units as members of SPV.
  2. Medical Devices clusters promoted by the State Governments: Such a Project Implementing Agency shall be legal entity under the Indian law with foresight of the State Governments. Such a cluster may be exempted from the requirement of formation of SPV & will be deemed to be an SPV for the purpose of this Scheme, provided separate accounts are maintained for the funds to be used for the projects assisted under AMD-CF and an Executive Committee (EC) is set up for implementation of the project.

Eligibility Criterion For SPV

  1. The SPV or the Executive Committee, as the case may be, will have representatives from cluster members, financial institutions, State and Central Government and R&D organization.
  2. Individual manufacturing unit cannot hold more than 40% in the SPV.
  3. Medical Devices enterprises shall hold at least 51% equity of the SPV iv. The combined net worth of members of SPV shall be equivalent to total grant amount applied for and each SPV member must have a net worth of at least 1.5 times of their proposed equity contribution.

Incentive under the Scheme :

For Common Infrastructure Facilities (CIF) for the Medical Device (MD) clusters, the limit of support will be 70% of the approved project cost or Rs. 20 cr., whichever is less, as per the approval of SSC. In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 20 Crore per Cluster or 90% of the project cost of the CIF, whichever is less

2. Assistance for Testing Facilities (TF)

To strengthen availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices.

Intended Beneficiaries and Eligibility Criteria

  1. National or State level Government or Private institutions interested to establish or strengthen testing facilities for medical devices to test Class A, B, C and D medical devices including In vitro diagnostic medical devices under MDR, 2017.
  2. Such legal entity under the Indian law will open a separate account for the funds to be utilized for the projects assisted under the sub-scheme.

Incentive under the scheme:

For Testing Facilities (TF) of Medical Device (MD) products, the limit of support will be 70% of the approved Testing Facilities project cost or Rs. 5 cr., whichever is less, as per the approval of SSC. In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 5 Crore per Cluster or 90% of the project cost of the CIF, whichever is less. Any expenditure above the prescribed limit shall be borne by the selected applicant.

Eligible Activities

An indicative list of eligible activities, for the testing facilities for the MD clusters, under this Scheme are as under:

  1. Component Testing Centre for ESDM/PCB/Sensors facility
  2. Electro-magnetic interference & Electro Magnetic Compatibility testing lab
  3. Biomaterial / Biocompatibility /Accelerated Aging testing lab
  4. Electronic and Electrical measuring, calibration and testing center
  5. AERB and NABL Certified X-ray Radiation testing lab
  6. Other Medical Devices testing lab etc.

Tenure of the Scheme: The tenure of the Scheme is from Financial Year 2023-24 to Financial Year 2026-27

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