PLI Scheme for medical devices: DoP invites applications from Category B applicants under revised guidelines

Published On 2022-08-29 12:30 GMT   |   Update On 2022-08-29 12:30 GMT

New Delhi: In order to boost the production of medical devices in the country, through a recent notification, the Department of Pharmaceuticals(DoP), Ministry of Chemicals and Fertilizers, has invited applications from eligible Category B applicants under the revised guidelines of the Production Link Incentive (PLI) Scheme for medical devices.

This came after the Department of Pharmaceuticals (DoP) issued revised Guidelines for the Production Linked Incentive (PLI) Scheme for Medical Devices.

The Medical Dialogues Team reported earlier that, in accordance with the revised guidelines, on the basis of indicative eligible products, the medical devices were classified into two categories (A and B).

As per the revised guidelines, the list of indicative eligible products, coming under "Category B" applicants, includes Brachytherapy Systems, Radiotherapy Simulation Systems, Workstations-Radiotherapy Planning, Proton therapy systems, Cyclotrons, Needles-Anesthesia, Syringes-Anesthesia, Anesthesia Kits, Masks-Anesthesia, Biopsy Kits- Renal, Dialyser reprocessing system, Lithotripters-Extracorporeal Renal,Cochlear Implants, Spinal and neuro-surgical implants, Urogynecologic Surgical Mesh Implants, Hernia Surgical Mesh Implants, Cerebral Spinal Fluid (CSF) Shunt Systems, Implanted Pacemakers, insulin pump, implaqted neuro-stimulated device like Deep Brain Stimulators, lntraocular lenses and others.

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In light of the foregoing, the Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, has recently issued a notice inviting applications from eligible Category B applicants. Additionally, the notification stated that only online applications will be accepted from qualified applicants from 1.9.2022 to 31.10.2022.

"Department of Pharmaceuticals issued Notification Guidelines of the PLI Scheme for Medical Devices on 21.07.2020, which got revised on 29.10.2020, and as per this, so far, 21 applicants were selected based on the applications received under two rounds of inviting applications." the notice revealed.

"Based on the arising needs, the Department has further revised the Guidelines of the PLI Scheme for Medical Devices and issued the same on 18.08.2022," the notice added.

Pursuant to this, the department has invited applications from eligible Category B applicants for medical devices listed under four target segments in Annexure 1A of the revised scheme guidelines as given below;

Sl. No

Name of the Segment

Indicative Eligible Products

1

Cancer care Radiotherapy medical devices

Brachytherapy Systems, Radiotherapy Simulation Systems, Workstations- Radiotherapy Planning, Proton therapy system and other products* in this target segment.

2

Radiology & Imaging medical devices (both ionizing & non-ionizing radiation products) and Nuclear Imaging Devices

Cyclotrons and other products* in this target segment

3

Anesthetics & Cardio- Respiratory medical devices including Catheters of Cardio Respiratory Category & Renal Care Medical Devices

Needles-Anesthesia, Syringes-Anesthesia,Anesthesia Kits, Masks -Anesthesia, Biopsy Kits- Renal , Dialyser reprocessing system, • Lithotripters-Extracorporeal -Renal and other products* in this target segment.

4

All Implants including implantable electronic devices

Cochlear Implants, Spinal and neuro-surgical implants, Urogynecologic Surgical Mesh Implants, Hernia Surgical Mesh Implants, Cerebral Spinal Fluid (CSF) Shunt Systems, Implanted Pacemakers , insulin pump , implaqted neuro-stimulated device like Deep Brain Stimulator,lntraocular lenses and other products* in this target segment

*- as defined in Page-18 of the revised Guidelines dated 18.8.2022

"Eligibility threshold criteria and Evaluation criteria shall be applicable as Annexure 2A and Annexure 3A respectively as detailed for Category-B applicants in the revised Guidelines of PLI scheme for Medical Devices dated 18.8.2022." the notice added.

For more details, check out the official notice on the link below:

https://pharmaceuticals.gov.in/sites/default/files/Notice pli md .pdf

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