Last Updated on January 6, 2024 by The Health Master
Medical Devices Rules for Hospital Imports
The Drugs Technical Advisory Board (DTAB) has recently put forth a recommendation to the Ministry of Health and Family Welfare (MoHFW) regarding the procurement of medical devices directly from original equipment manufacturers (OEMs).
The proposal aims to introduce an amendment to the existing Medical Devices Rules (MDR), 2017.
In order to gather insights and perspectives, the DTAB suggests involving various stakeholders, including reputable institutions like the All India Institute of Medical Sciences (AIIMS) and officials from the MoHFW.
Current Practices and Proposed Amendment
During its recent meeting, the DTAB delved into various technical aspects related to drugs, medical devices, and related matters.
One of the key discussions revolved around creating a provision within the MDR, 2017 that allows hospitals to import medical devices directly from OEMs without requiring an import license.
Currently, renowned healthcare facilities such as AIIMS, Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh, Directorate General Armed Force Medical Services, and Medanta Hospital import medical devices directly from OEMs for internal use.
However, based on the Ministry of Health’s orders issued on February 8 and December 27, 2019, as well as a notification on February 11, 2020, an import license is mandated for the importation of medical devices, in accordance with the provisions outlined in the MDR, 2017.
Also read: Drugs Technical Advisory Board (DTAB): Minutes of meetings
In light of this, the DTAB has emphasized the need for a specific provision within the MDR, 2017 that permits hospitals to directly import such medical devices.
The suggested amendment would be incorporated into the Eighth Schedule of the MDR, 2017, exempting hospitals from Chapter V provisions and enabling them to import medical devices on behalf of authorized agents.
However, certain conditions would apply to ensure safety and quality control.
These conditions include the manufacturer and medical devices being registered using Form MD-15 by the authorized agent, submission of an authorization letter from the authorized agent to the Port Office of the Central Drugs Standard Control Organisation (CDSCO) during the import process, and the authorized agent assuming responsibility for the safety, quality, and performance of the imported medical devices.
Consultation and Further Steps
In order to gain a comprehensive understanding of the procurement practices currently followed by hospitals and institutes like AIIMS, PGIMER, Medanta, and DGFAMS, the DTAB recommends conducting consultations with these stakeholders and the advisor (costs) of the MoHFW.
These consultations would provide valuable insights to guide subsequent actions regarding the proposed amendment.
Background on the MDR Amendments
On February 11, 2020, the MoHFW introduced an amendment to the MDR, 2017, incorporating Chapter IIIA into the Rules.
This new chapter focused on the registration of specific medical devices and outlined provisions for registration applicable to both manufacturers and importers.
Notably, on February 8, 2019, the MoHFW issued a notification categorizing eight medical device categories, as drugs intended for use in humans including:
- Implantable medical devices,
- CT scan equipment,
- MRI equipment,
- Defibrillators,
- Dialysis machines,
- PET equipment,
- X-ray machines,
- Bone marrow cell separators.
This categorization came into effect on April 1, 2020.
Subsequently, a notification on December 17, 2019, extended the registration deadline for these medical devices to April 1, 2021.
Conclusion
The DTAB’s recent recommendation to the MoHFW regarding the procurement of medical devices directly from OEMs highlights the need for an amendment to the existing MDR, 2017.
This proposed amendment aims to create a provision allowing hospitals to import medical devices without an import license, subject to certain conditions.
By engaging in consultations with stakeholders, including renowned hospitals and institutes, the government can better understand the procurement practices and take appropriate action in this matter.
The previous amendments to the MDR, 2017, which categorized certain medical devices as drugs and established registration requirements, provide additional context for the current proposal.
Procedure to obtain license for manufacturing of Medical Devices
Procedure for registration of Medical Devices: CDSCO
Registration for sale of Medical Devices: Procedure and conditions
Latest Notifications: Medical Devices
Classifications of Medical Devices under the provisions of MDR 2017
Notified Bodies for Medical Devices
Updated list of Notified Bodies for Medical Devices
Updated list of Medical Device Testing Laboratories (MDTLs)
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