Mandatory Declarations for importers of Medical Devices in Covid-19 Pandemic

In the current pandemic situation of COVID19, there is a huge demand for medical devices. There is a dire need of various medical devices to the medical industry on an urgent basis to meet the needs of the population and provide effective patient care. On 28 th April, 2021, Ministry of Consumer Affairs, Food and Public Distribution, has made some relaxations for the medical device industry to help cope with increased demands. [1]

The Legal Metrology (Packaged Commodities) Rules, 2011:

Permission was granted for making mandatory declarations under Legal Metrology (Packaged Commodities) Rules, 2011 after passing goods through customs to enter or leave the country and before sale to importers of medical devices in the current situation of COVID-19. [1]
Rule 6 under the Legal Metrology (Packaged Commodities) Rules, 2011 states that every package kept for sale must bear the necessary details such as the name and complete address of the manufacturer and keep ready before import. Rule 33(1) under the Legal Metrology (Packaged Commodities) Rules, 2011 states that the central government has the power to relax one or more provisions of the rules to make the supply of imported goods easier and faster. [2]

The surge in need for medical devices:

Due to the serious shortage of essential medical devices, the health care system is overwhelmed. To meet the demand for medical devices in this current pandemic situation of Covid-19, the Central government has the power to permit a faster supply of the medical devices under rule 33(1) and rule 6 of Legal Metrology (Packaged Commodities) Rules,2011. It states that importers can import medical devices for a period of three months with a declaration made on every package immediately after customs clearance/ import and before the sale from the date of advisory. The central government can relax some provisions in the given rules considering the need of the hour and permit sending as many packages as possible without actually putting a label by way of stamping or stickering with all the necessary declarations as given under Rule 6 of Legal Metrology (Packaged Commodities) Rules, 2011.

Medical Device shortage related to Covid-19:

The following rules apply to the medical devices given: [1]

Sr No	Name of the Medical Device
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 and gaseous oxygen
7.	Oxygen Canister
8.	Oxygen Filing systems
9.	Oxygen cylinders, including cryogenic cylinders
10.	Oxygen Generators
11.	Parts to be used to manufacture 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 a nasal cannula; Compressors including all accessories and tubing; humidifiers and Viral filters
14.	High flow nasal cannula 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

Immediately after importing the medical devices mentioned above, under this permission, the importers should inform the quantity of all the imports to the Director (Legal Metrology) and Controller (Legal Metrology) in whichever state the import is made. [1]

We are in the midst of a global health crisis that expects the medical device industries to work closely with healthcare facilities with the help of government organizations and regulations to ease the supply of these devices for the sake of public health. To combat the current situation of the shortage in supply during the pandemic and to also avoid such crises in the future, it is important to focus on strengthening the medical devices sector with appropriate support from the government.

Summary:

We are in the midst of a global health crisis that expects the medical device industries to work closely with healthcare facilities with the help of government organizations and regulations to ease the supply of these devices for the sake of public health. To overcome the current situation of the shortage in supply the government is giving certain relaxations to medical device importers/manufacturers.

Short Description:

The Covid 19 pandemic has affected most of the healthcare sectors as well as the manufacturing sectors. Due to increased demand during the pandemic, the manufacturing supply chains are facing immense challenges to meet the high demand. The Central Government has made declarations for the importers of medical devices which provides some relaxation to speed up the supply process according to the rules which come under the Legal Metrology (Packaged Commodities) Rules, 2011.

References:

1. Ministry of Consumer Affairs, Food and Public Distribution: Department of Consumer Affairs, Legal Metrology Division. [Internet] Available at: https://consumeraffairs.nic.in/sites/default/files/file-uploads/latestnews/Permission%20for%20medical%20devices%20due%20to%20prevelent%20sutuation%20of%20Covid%2019.pdf Accessed on May 18, 2021.
2. Ministry of Consumer Affairs, Food and Public Distribution: Department of ConsumerAffairs, The Legal Metrology (Packaged Commodities) Rules, 2011 [Internet] Available at: https://megweights.gov.in/acts/Legal-Metrology-Packaged-Commodities-Rules-2011.pdf Accessed on May 18, 2021.
3. Rental Equipment TFR [Internet] Available at:
   http://www.totalfitnessrepair.com/rental-equipment-tfr.html Accessed on May 19,2021