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Permission to Import Medical Devices and Mandatory Declarations u/Legal Metrology

May 13, 2021

The Ministry of Consumer Affairs, Food and Public Distribution has issued a notification dated April 28, 2021 to the Director General, Foreign Trade and Controllers of Metrology permitting the importers of medical devices to import the listed medical devices for three months from the date of the advisory[1]. The permission to import the medical devices is subject to the condition that the importers shall make all declarations required under Legal Metrology (Packaged Commodities) Rules, 2011 immediately after import/ custom clearance and before sale.

Medical Devices Allowed for Import

  1. Nebulizers,
  2. Oxygen concentrators,
  3. Continuous positive airway pressure (CPAP) devices,
  4. Bilevel positive airway pressure (BIPAP) devices]
  5. Oxygen concentrator along with flow meter, regulator, connectors and tubing
  6. Vacuum Pressure Swing Absorption (VPSA) and Pressure Swing Absorption (PSA) oxygen plants, Cryogenic Oxygen Air Separation Units (ASUs) producing liquid/ gaseous oxygen
  7. Oxygen Cannister
  8. Oxygen Filling Systems
  9. Oxygen cylinders including cryogenic cylinders
  10. Oxygen Generators
  11. Parts to be used for the manufacture of equipment for production transportation distribution or storage of Oxygen ‘ ‘
  12. Any other device from which Oxygen can be generated
  13. Ventilators (capable of functioning as high-flow devices) with nasal canula; Compressor including all accessories and tubing; humidifiers and Viral filters
  14. High flow nasal canula device with all attachments
  15. Helmets for use with non-invasive ventilation
  16. Non-invasive ventilation oronasal masks for ICU ventilators
  17. Non-invasive ventilation nasal masks for ICU ventilators

The mandatory declarations on these medical devices can be made by way of stamping or putting sticker or online printing.

While the entire nation is battling the pandemic and the demand for medical devices is increasing day-by-day, the permission issued by the Ministry for import of medical devices is a welcome move and is a huge sigh of relief when an acute shortage of medical devices has made people helpless and led to the death of several countrymen. However, while importing the medical devices, the importers shall adhere to the provisions of mandatory declarations required under the provisions of the Legal Metrology (Packaged Commodities) Rules, 2011.

To know more about the mandatory declarations made under the Legal Metrology (Packaged Commodities) Rules, 2011, click here.

Also read- Medical Devices Manufacturing- India

[1] https://consumeraffairs.nic.in/sites/default/files/file-uploads/latestnews/Permission%20for%20medical%20devices%20due%20to%20prevelent%20sutuation%20of%20Covid%2019.pdf

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