Monday, May 31, 2021

Import Of Covid 19 Antigen Test Kit In US

Covid 19 antigen test kit and other in vitro diagnostic devices (IVDs) are FDA-regulated products that require FDA and Customs and Border Protection (CBP) clearance when imported into the US. The FDA regulates imported medical devices and IVDs. Generally, imported devices must have FDA marketing approval or must be authorized under an approved Investigational Device Exemption (IDE), or other FDA-approved application or exemption. Devices that cannot meet these criteria are often refused entry by the FDA.

Covid 19 antigen test kit, by contrast, could help to rapidly identify people who have high levels of virus — those who are most likely to be infectious to others — and isolate them from the community. 

Covid 19 antigen test kit – In US

The Covid 19 antigen test kit detect specific proteins — known as antigens — on the surface of the virus, and can identify people who are at the peak of infection, when virus levels in the body are likely to be high.  Proponents argue that this could be a game changer. Covid 19 antigen test kit could help to keep the pandemic at bay, because they can be rolled out in vast numbers and can spot those who are at greatest risk of spreading the disease. 

These tests are also a key element in the testing strategies of other countries, such as India and Italy. Covid 19 antigen test kit are much faster and cheaper than the gold-standard tests that detect viral RNA using a technique called the polymerase chain reaction (PCR).But antigen tests aren’t as sensitive as the PCR versions, which can pick up minuscule amounts of the SARS-CoV-2 virus that causes COVID-19. Covid 19 antigen test kit give results in less than 30 minutes, don’t have to be processed in a lab and are cheap to produce. Yet that speed comes with a cost in sensitivity. 

Import covid 19 antigen test kit

When importing Covid 19 antigen test kit or devices, importers must provide product details and specify which FDA authorizations apply to the devices in order to obtain a Customs and FDA release. Failure to declare the imported devices correctly may result in clearance delays or entry refusal by the agencies. To facilitate access to Covid 19 antigen test kit, the FDA has issued Emergency Use Authorization (EUA) and enforcement discretion policies that allow certain COVID-19 IVDs to be imported and marketed in the US. 

If  You Want Medical Devices Services Consultation For Following.
  1. Medical Device Consulting 
  2. cdsco registration 
  3. FDA 510k Clearance 
  4. ce mark medical device 
  5. CDSCO Manufacturing License 
  6. CDSCO import license 
  7. TURNKEY PROJECT CONSULTANT 
  8. medical device manufacturing 
  9. iso 15378 certification 
  10. 21 cfr part 210 and 211 
  11. ISO 13485 Medical Device Consultant 
  12. Primary Packaging Turnkey Project Consultant 
  13. Clean Room Design Consultant 
  14. manufacturing site conceptualization 
  15. Market Analysis and feasibility for Medical Devices 
  16. manufacturing plant layout design 
  17. medical device design and development 
  18. DMF file submission guideline 
  19. 21 cfr part 820 
  20. qms certification services 
  21. capa management 
  22. design control requirements 
  23. medical device process validation 
  24. combination product 
  25. continuous improvement program 
  26. Medical Device Compliance & Regulatory Services 
  27. Cdsco India authorized agent for medical device   

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Thursday, May 27, 2021

How to get Medical device registration in India?

With advancing medical technology, the medical device market is expected to grow over the next several years due to increased health awareness, a growing middle class, and government health initiatives. The medical device registarion process in India is overhauled in 2017 with the publication of the Medical Device Rules.The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare. today there are registration procedures for certain types of medical devices regulated under the Medical Device Rules. While the list of regulated products is specific, the CDSCO occasionally adds products to the list. Determining if your product is regulated by the CDSCO is the first step marketing entry in India.

Process for Medical device registration in India

Through the notification dated February 11, 2020 the Government has mandated the registration of all devices, except for the notified categories, through the procedure set down in Chapter IIIA of the Rules. In effect, combined with the amendment of the definition, all Medical devices require registration for manufacture and import from April 1, 2020 onward.

Classification of Medical Devices

At present, approximately 40-50 Medical device registeration in India, are done and those are notified, and there is no formal classification of the different types of medical devices for these devices. However, the categorization that  will be available in future is as follows:

Class A – Low Risk Medical Devices such as thermometers and tongue depressors

Class B – Low-moderate Risk Medical Devices such as hypodermic needles and suction equipment

Class C – Moderate-high risk Medical Devices such as lung ventilator and bone fixation

Class D – High Risk Medical Devices such as heart valves and implantable devices

If  You Want Medical Devices Services Consultation For Following.

    2.     CDSCO Registration
    3.     FDA 510 k clearance
    5.     Design Control Requirements
    6.     QMS Certification Services
 11. Medical Device Design And Development 


 

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Monday, May 24, 2021

Impact of COVID-19 on Medical Devices


Impact of COVID-19 on medical devices growth, has been expontential. Hospitals are struggling as the disease spreads faster than companies can produce masks, ventilators, and tests. As of early May 2020, over 4.7 million people have been confirmed to be infected with the SARS-CoV-2 coronavirus, and governments are scrambling to contain its spread. The high R0 value (a measure of contagiousness- estimated to be between 2.0 and 3.02) of SARS-CoV-2 means that those infected copiously spread the virus and develop complications suddenly.

As a result, health care systems are overwhelmed, and the effective delivery of medical care to all patients has become a challenge worldwide. The Impact by COVID-19 on medical devices industry has left the healthcare systems being overwhelmed. The effective delivery of medical care to all patients has become a challenge worldwide. Insufficient attention to early warning signs, inadequate stockpiling, lack of access to testing kits and personal protective equipment (PPE), and nationwide variability in the approaches to testing, distribution of PPE, and timing and degree of social distancing measures likely all affected the spread of the disease. 

Impact of COVID-19 on medical device  

The unprecedented situation created by the COVID-19, has resulted in alarm bells ringing across industries. After multiple lockdowns to curb the spread of infection, we are now in the phase of unlock 3.0 where businesses are cautiously starting to resume operations. It is estimated that due to the impact of COVID-19 on medical device the medical technology industry has suffered a 50-85 per cent drop in revenue across categories in April-June due to the situation. Slicing the data category wise shows us that the cardiology category experienced a downfall in revenue up to 60 per cent in the first quarter of the financial year.

The medical device industry has borne the brunt of these issues, and has been strained for revenues, it is bleeding, yet has shown resilience and commitment by working unrelentingly to ensure availability of products (for both COVID and non-COVID emergencies) across the country. The pandemic shortages have illustrated the limits of our resources despite existing medical companies maximising their efforts. Given the capacity constraints, the medical device regulatory environment is adapting to meet the challenges by becoming more agile to reduce time to market while attempting to keep quality and safety at the forefront.

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.
  1. Medical Device Consulting 
  2. cdsco registration 
  3. FDA 510k Clearance 
  4. ce mark medical device 
  5. CDSCO Manufacturing License 
  6. CDSCO import license 
  7. TURNKEY PROJECT CONSULTANT 
  8. medical device manufacturing 
  9. iso 15378 certification 
  10. 21 cfr part 210 and 211 
  11. ISO 13485 Medical Device Consultant 
  12. Primary Packaging Turnkey Project Consultant 
  13. Clean Room Design Consultant 
  14. manufacturing site conceptualization 
  15. Market Analysis and feasibility for Medical Devices 
  16. manufacturing plant layout design 
  17. medical device design and development 
  18. DMF file submission guideline 
  19. 21 cfr part 820 
  20. qms certification services 
  21. capa management 
  22. design control requirements 
  23. medical device process validation 
  24. combination product 
  25. continuous improvement program 
  26. Medical Device Compliance & Regulatory Services 
  27. Cdsco India authorized agent for medical device   

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CDSCO Import License for Medical Devices In India

  Central Drugs Standard Control Organisation is, known as CDSCO, is a regulatory body for the Indian medical devices industry, under the vi...