Import of 17 medical devices allowed

The Government of India recently allowed import of seventeen medical devices to provide relief to the COVID-19 patients. However, the importer should make mandatory declarations under Legal Metrology Rules, 2011.

Which devices were allowed?

The Department of Consumer Affairs has allowed the import of the following devices:

  • Nebulizers
  • oxygen concentrators
  • CPAP and BIPAP devices
  • Vacuum Pressure Swing Absorption
  • Pressure Swing Absorption
  • Oxygen Plants
  • Cryogenic Oxygen Air Separation Unit
  • oxygen canister
  • oxygen filling systems
  • oxygen cylinders including cryogenic cylinders
  • Ventilators

About the Notification

The notification issued by GoI says that the imported items should comply Rule 33(1) and Rule 6 of the Legal Metrology (Packaged Commodity) Rules, 2011. These rules makes it mandatory for the importers to put proper stamping or stickers or online printing revealing required information.

What are Legal Metrology Rules?

The Legal Metrology Rules were framed to regulate pre-packaged commodities. Under the rules, the pre packaged commodities have to comply mandatory labelling requirement.

The laws related to Metrology in India are as follows:

  • Legal Metrology Act, 2009
  • Legal Metrology (Packaged Commodities) Rules, 2011
  • Legal Metrology (General) Rules, 2011

About Import of Medical Devices in India

A person having license under the Drug and Cosmetics Act, 1940 can import medical devices in the country. Import, sale, manufacturing and distribution of medical devices are regulated by the same act. The Central Drugs Standard Control Organisation (CDSCO) governs the regulations of import of medical devices in the country.

CDSCO

It is responsible for approval of drugs. However, recently GoI included some of the medical devices under the Drugs and Cosmetics Act. Currently, there are thirty seven medical devices regulated under the act.

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