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1-10/ 22/ 2020-W&M
Government of India
Ministry of Consumer Affairs, Food and Public Distribution
Department of Consumer Affairs
Legal Metrology Division

Krishi Bhawan, New Delhi
Dated: 28.4.2021


1. Director General, Foreign Trade,
Ministry of Commerce & Industry, Udyog Bhawan, New Delhi

2. Controllers of Legal Metrology,
All States/ UTs

Subject: Permission for making mandatory declarations required under the Legal Metrology (Packaged Commodities) Rules, 2011 after custom clearance and before sale to importers of medical devices due to prevalent situation of COVID-19 – reg.

Sir/ Madam,

The undersigned is directed to refer to the above-mentioned subject and to state that due to prevalent pandemic situation of COVID-19 there is a steep demand of medical devices in this critical condition on urgent basis in view of the emergent health concerns and immediate supply to the medical industry.

2. Therefore, considering the pandemic situation of COVID-19 and to meet the demand of medical devices, in exercise of the powers conferred by rule 33(1) and rule 6 of the Legal Metrology (Packaged Commodities) Rules, 2011, the Central Government hereby permits the importers of medical devices to import the following medical devices for three months from the date of this advisory, subject to the condition that the importers shall make all declarations required under these rules immediately after import/ custom clearance and before sale by way of stamping or putting sticker or online printing, as the case may be:

(i) Nebulizers,

(ii) Oxygen concentrators,

(iii) Continuous positive airway pressure (CPAP) devices,

(iv )Bilevel positive airway pressure (BIPAP) devices]

(v) Oxygen concentrator along with flow meter, regulator, connectors and tubing

(vi) Vacuum Pressure Swing Absorption (VPSA) and Pressure Swing Absorption (PSA) oxygen plants, Cryogenic Oxygen Air Separation Units (ASUs) producing liquid/ gaseous oxygen

(vii) Oxygen Cannister

(viii) Oxygen Filling Systems

(ix) Oxygen cylinders including cryogenic cylinders

(x) Oxygen Generators

(xi) Parts to be used for the manufacture of equipment for production, transportation, distribution or storage of Oxygen

(xii) Any other device from which Oxygen can be generated

(xiii) Ventilators (capable of functioning as high-flow devices) with nasal canula; Compressors including all accessories and tubing; humidifiers and Viral filters

(xiv) High flow nasal canula device with all attachments

(xv) Helmets for use with non-invasive ventilation

(xvi) Non-invasive ventilation oronasal masks for ICU ventilators

(xvii) Non-invasive ventilation nasal masks for ICU ventilators

3. The importers, importing the said medical devices under this permission shall inform all such imports with quantity imported to the Director (Legal Metrology) and the Controller (Legal Metrology) in the State, where the import is made, immediately after import.

Yours faithfully

(B. N. Dixit)
Director of Legal Metrology
Tel: 011-23389489/ Fax.-011-23385322
Email: dirwm-caftnic.in

Copy to: All Industries/ Industry Associations/ Stake Holders


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