In the ongoing pandemic, the demand for disinfectants and sanitizers has grown manifold. To meet the increasing requirements, the WHO has recommended two formulations based on 75% Isopropyl alcohol and 80% Ethanol separately for local manufacturing. Know more here!
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Indian in vitro diagnostics market opportunity analysis 2018 - Reports CornerReports Corner
The Indian IVD market is valued at more than US$ 500 Million, and is expected to touch the US$ 1 Billion in 2016 growing steady at a CAGR of 19%. This remarkable growth can be attributed to increased healthcare awareness, desire to undergo preventive health checkups, availability of disease specific tests, corporate setups promoting health focus of employees, and drift from manual to semi-automated and automated equipment.
https://www.reportscorner.com/reports/16265/Indian-In-Vitro-Diagnostics-Market-Opportunity-Analysis-2018/
Medical device classification following MDR 2017/745Monir EL AZZOUZI
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Indian in vitro diagnostics market opportunity analysis 2018 - Reports CornerReports Corner
The Indian IVD market is valued at more than US$ 500 Million, and is expected to touch the US$ 1 Billion in 2016 growing steady at a CAGR of 19%. This remarkable growth can be attributed to increased healthcare awareness, desire to undergo preventive health checkups, availability of disease specific tests, corporate setups promoting health focus of employees, and drift from manual to semi-automated and automated equipment.
https://www.reportscorner.com/reports/16265/Indian-In-Vitro-Diagnostics-Market-Opportunity-Analysis-2018/
Medical device classification following MDR 2017/745Monir EL AZZOUZI
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Understanding FDA Requirements Medical Devicesmarchell
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
As FDA begins to restart on-site inspections of domestic and foreign sites, Health Canada on the other hand has all of its on-site domestic and foreign inspections for drug good manufacturing practices postponed until further notice...
MakroCare provides information about labeling requirements/changes in COVID period. FDA is committed to providing timely guidance to support response efforts to this pandemic situation of COVID-19.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
As you start to map out your global strategy beyond the US, Canada and Europe, there are six key steps to follow and multiple regulations to consider. Harmonization has increased in recent years, yet most countries still maintain distinct medical device regulatory systems. Careful analysis on a market-by-market basis will help you to fully realize compliance requirements affecting a particular market. Explore these six steps as we reveal insights into the unique medical device regulations affecting markets in Russia, Brazil, Japan, China, and India.
Can I Use My International SDS in Canada?Dell Tech
This session will provide a quick overview of the requirements for the Canadian Safety Data Sheet (SDS). Current Canadian SDSs must comply with the Hazardous Products Regulations (HPR) and in particular, GHS Version 5 statements.
If you manufacture or sell product(s) in other countries, you must have an SDS that is compliant for the country you are looking to sell to. Sending your US SDS and simply translating into Canadian French does not mean that your product SDS is compliant here - a fact that is often overlooked by many.
Health Canada’s COVID-19 Interim Guidance on Hand SanitizersEMMAIntl
Hand sanitizers in Canada are regulated by the Natural and Non-Prescription Health Products Directorate (NNHPD). When the pandemic was at its peak, NNHPD released an interim guidance for expedited approval of hand sanitizers to help mitigate supply shortages. The expedited process allowed for manufacturers to obtain a site license and a product license by implementing any of the following GMPs...
Canada has been facing the same difficulties as many other nations due to the novel coronavirus. In light of the shortage of medical equipment and the PPEs, Health Canada relaxed their policies to let medical equipment and other necessary supplies to be distributed in Canada. Below are some of the policies that Health Canada rolled out to prevent shortages of supplies and ensuring that safe and effective products are distributed in the market for use...
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Understanding FDA Requirements Medical Devicesmarchell
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
As FDA begins to restart on-site inspections of domestic and foreign sites, Health Canada on the other hand has all of its on-site domestic and foreign inspections for drug good manufacturing practices postponed until further notice...
MakroCare provides information about labeling requirements/changes in COVID period. FDA is committed to providing timely guidance to support response efforts to this pandemic situation of COVID-19.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
As you start to map out your global strategy beyond the US, Canada and Europe, there are six key steps to follow and multiple regulations to consider. Harmonization has increased in recent years, yet most countries still maintain distinct medical device regulatory systems. Careful analysis on a market-by-market basis will help you to fully realize compliance requirements affecting a particular market. Explore these six steps as we reveal insights into the unique medical device regulations affecting markets in Russia, Brazil, Japan, China, and India.
Can I Use My International SDS in Canada?Dell Tech
This session will provide a quick overview of the requirements for the Canadian Safety Data Sheet (SDS). Current Canadian SDSs must comply with the Hazardous Products Regulations (HPR) and in particular, GHS Version 5 statements.
If you manufacture or sell product(s) in other countries, you must have an SDS that is compliant for the country you are looking to sell to. Sending your US SDS and simply translating into Canadian French does not mean that your product SDS is compliant here - a fact that is often overlooked by many.
Health Canada’s COVID-19 Interim Guidance on Hand SanitizersEMMAIntl
Hand sanitizers in Canada are regulated by the Natural and Non-Prescription Health Products Directorate (NNHPD). When the pandemic was at its peak, NNHPD released an interim guidance for expedited approval of hand sanitizers to help mitigate supply shortages. The expedited process allowed for manufacturers to obtain a site license and a product license by implementing any of the following GMPs...
Canada has been facing the same difficulties as many other nations due to the novel coronavirus. In light of the shortage of medical equipment and the PPEs, Health Canada relaxed their policies to let medical equipment and other necessary supplies to be distributed in Canada. Below are some of the policies that Health Canada rolled out to prevent shortages of supplies and ensuring that safe and effective products are distributed in the market for use...
Earlier this year, the Department of Health and Human Services proposed exempting 84 types of Class II devices from 510(k) requirements, which stemmed from the relaxed regulations for the COVID-19 public health emergency. After reviewing adverse event data from both before and after the relaxed pandemic regulations, the FDA began to examine its current market authorization process for medical devices...
FDA Extends the Timeline to Respond to Additional Information RequestsEMMAIntl
The FDA revised its guidance document ‘Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers’ which was originally released in June, to give device sponsors additional time in responding to FDA’s requests for additional information for device applications that are on hold.
At the onset of the pandemic, FDA realized that device makers were faced with unprecedented challenges related to supply chain issues, human resources, etc., while on the other hand, the FDA saw a surge in EUA activities which required shifting of staff resources at the FDA. During this time, the FDA released a guidance document to extend the timeline for responding to the FDA’s requests for submissions/applications that were put on hold. The originally released guidance document provided a sigh of relief to device sponsors by allowing an additional 90 day period beyond the response date initially assigned...
COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, was officially declared a pandemic back in early March. Since then the medical device industry has been trying to adjust to the far-reaching obstacles presented by this public health emergency, such as global supply chain shortages, social distancing risks, and more. As such, the FDA has also had to make significant and unprecedented changes to mitigate risks and make sure that public safety is continuously protected. In this paper, we will explore the FDA’s response to COVID-19 cohesively, looking at how the agency has had to modify some of its processes and policies, relax regulatory requirements, and what the future of the regulatory-landscape looks like for the medical device industry post-COVID-19...
Amid the COVID 19 pandemic, with 10 states in the US declaring a ‘state of emergency’, foreign and international travel restrictions, FDA released a series of advisories and statements to keep the public informed of the situation. The FDA is working with U.S. government partners including the Centers for Disease Control and Prevention (CDC), medical product manufacturers, and international partners to control the situation surrounding the COVID 19 outbreak...
REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREME...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA 201T)
Semester II - Regulatory Aspects of Drugs and Cosmetics (MRA 201T)
Unit V - Regulatory pre-requisites related to Marketing authorization requirements for drugs and post approval requirements in Saudi Arabia
(REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREMENTS IN SAUDI ARABIA)
Drug approval process in Saudi Arabia - Saudi Food & Drug Authority
FDA’s Electronic Premarket Submissions Pilot ProgramEMMAIntl
The US FDA’s Center for Devices and Radiological Health (CDRH) announced a new pilot program that will allow the industry to submit premarket submissions electronically during the COVID-19 health emergency.
The Electronic Delivery of Premarket Submissions Pilot Program’s objective is to test CDRH’s capabilities to receive pre-market submissions using BOX, which is a cloud-based sharing service. CDRH began accepting participants for this pilot on October 6th,2020 and the program is intended to last 90 days during the COVID-19 pandemic...
A Survey on Current Applications for Tracking COVID-19EMMAIntl
The COVID-19 pandemic is still creating headlines in the health care domain. Around the world, governments, and organizations such as World Health Organization (WHO), European Medical Agency (EMA), and FDA are working together to eliminate lockdowns and get our society back up and running. In such cases, several companies, firms, and universities have found opportunities to provide critical services such as virus detection, tracking, data-driven decision-making algorithms, and visual analytic applications...
FDA’s Plan to Re-Start Routine InspectionsEMMAIntl
Back in March amid the beginning of the COVID-19 pandemic, the FDA announced that in addition to postponing all international inspections, it would also be temporarily halting all domestic routine surveillance inspections. This unusual move by the agency was made to protect the health of all FDA staff and in response to the growing industry concerns about visitors to medical device facilities...
Strategies for ensuring a Medical Device released under EUA will stay on the ...Greenlight Guru
During the pandemic the FDA has approved over 70 medical devices, so far, for use to diagnose or treat COVID-19. The EUA regulatory approval pathway requires that minimal supporting documentation be submitted to receive approval. The EUA approval is a temporary approval and authorization for use of devices approved under the EUA will end in the (relatively) near future. In this session RND Group will describe activities companies need to be doing now to prepare and submit their device for approval through non-EUA regulatory pathways to ensure their device can remain on the market after EUA approval expires.
Talk Takeaways:
• EUA approval is truly temporary and once EUA approval expires, a product must be removed from the market if it is not otherwise approved or cleared
• In parallel to EUA, a “normal” FDA submission should be prepared and submitted under 510(k), PMA, or other regulatory approval pathway
• Assessing the design and development approach used for an EUA-approved device will identify gaps to be addressed to prepare a “normal” submission
• Companies without prior successful FDA submission experience are most at risk for not being prepared and for not receiving a timely approval of a follow-up submission after their EUA expires
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Marketing Your Hand Sanitizer During the COVID-19 PandemicEMMAIntl
Health care facilities are facing shortages of medical equipment, drugs, PPEs and essentials such as hand sanitizers. Hand sanitizers were the first ones to go out of stock from stores. To account for this hand sanitizer shortage, FDA is asking for facilities with the ability to manufacture hand sanitizers to help during the outbreak...
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
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Sheet Metal Fabrication & Machining Parts Case StudyJohn William
Dragon Sourcing aimed to source sheet metal fabrication and machining parts from South of India, especially Tamil Nadu and other bordering states. The sourcing approach included demand analysis, supply market analysis, telephone pre-screening, NDA process, developing RFI/RFQ document, administering RFI/RFQ and then, analysing RFI/RFQ responses.
RFI process intended to find the right suppliers. After supply market analysis, supplier rejection analysis was done where many suppliers’ name struck off the list during the pre-screening, NDA and RFI/RFQ method. The E-sourcing GPS tool was used to score and rank the suppliers before making the final call.
Chennai, Puducherry, Coimbatore and Madurai have the highest suppliers of sheet metal parts. The company carried out the project in 2 months with 83 suppliers from the states of South Indian. The report prepared by our team has helped our client to recognise potential suppliers located across Tamil Nadu and neighbouring states.
Cooling Towel Sourcing Project - Case StudyJohn William
A leading German company was looking for potential suppliers of microfiber cooling towels from China and so they checked the Dragon Sourcing database. Find full case study here!
Newsletter on PPE: Classification of PPE and CE Certification Process in EUJohn William
In the wake of the high demand for PPE and medical devices in the EU, Chinese suppliers have restarted exporting to Europe. However, the European Safety Federation has identified some suspicious CE certificates for both PPE and medical devices. The suppliers have either used fake documents or showed certificates by the wrong authorities. Since a CE mark is compulsory for all PPE and medical devices exported to Europe, this newsletter delves into product classification for PPE and medical devices and product classification by EU regulation. There are 2 regulations, namely, Regulation (EU) 2016/425, which is on PPE and Regulation (EU) 2017/745, which is on medical devices and accessories. It has been mandated that all medical products and PPE to be sold in the EU need to come under any of these regulations. All suppliers should have knowledge about the procedure for Certified CE Mark, the risk categories, classification of medical devices and types of notified bodies as well as their names in the regulations.
Study on Sourcing Opportunities in VietnamJohn William
Vietnam is a rapidly developing economy largely depending on agriculture (70% of the population). As many as 20 popular retail companies like Tesco and Metro have set up purchase offices in the country. While its textile & garment and footwear industries are growing, they are attracting famous brands, the likes of which are Abercrombie, Decathlon and Adidas, Nike respectively for each industry. Endowed with over 60 types of minerals, it is the 3rd largest mineral producer in South East Asia. Vietnam is suitable for the seafood industry andis the 4th biggest seafood from aquaculture producer in the world. It is the 2nd largest producer and exporter of coffee, besides the largest cashew exporter for the 9th year in a row in 2018. Get in touch with a Vietnam sourcing agency after you read this report and are interested to procure from the country.
Study on Sourcing Opportunities in BrazilJohn William
The economy of Brazil is developing and it is the world’s 9th largest free-market economy in terms of the GDP. In 2018, their oil seeds industry achieved an export value of 33.5 billion USD, with the top destinations being the Netherlands, China, Thailand, Spain and Taipei. Following this mark is the country’s mineral fuels sector with its natural gas and crude oil reaching a value of $29.6 billion. The mining industry also backs them up with its iron ore business, which climbed up to $23.6 billion by mostly exporting in Japan, China, Korea, Germany, and the Netherlands. Although not close to its top mark, Brazil also relies on its industrial machinery and steel and iron products. Check the complete report for insights into the region’s sourcing opportunities that are displayed using stats and graphical representations.
Study on Sourcing Opportunities in EthiopiaJohn William
Ethiopia, located in the horn of Africa, is a reservoir of plenty. With abundant natural resources, it is one of the favoured developing countries for investing. You can talk to an Ethiopia sourcing agency to learn about the various opportunities of trade in the country. The birthplace of Arabic coffee, the nation exported 963031 thousand USD in 2017 of coffee and spices. The government plans to export 1.8 million tons of coffee by 2024. Known for its diversity in cultivated sesame, the country partners with Israel, the USA and China among others. Ethiopia has been mining gold since ancient times and it is the major mineral export. Boasting Africa’s largest livestock population of 60 million, Ethiopian goat and ship skin is known across the world for making designer gloves.
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Sanitizer & Disinfectants During COVID 19 – A Brief Study
1. Sanitizer & Disinfectants during Covid-19
A Brief Study
Newsletter VII
Covid-19 cases by 3rd August, 2020
August 2020
2. Coronavirus pandemic has already crossed 18.4 million cases globally.
No vaccine or medicines are yet invented to break off this pandemic.
One and most common way adapted all over the world to protect self from this deadly
virus is to repeatedly wash hands with soap or sanitizer and keep the surroundings clean
using disinfectants.
Regarding skin reactions, Hand rub with alcohol-based solutions are better tolerable
than hand washing with soap and water. But if hands are visibly soiled then soap and
water are recommended.
This increased sales and demand of sanitizers and disinfectants dramatically, worldwide.
In order to cope up with surging demand, WHO has recommended two alcohol-based
hand rub formulations for local production.
FORMULATION 1 FORMULATION 2
Ethanol 80% (v/v) Isopropyl alcohol 75% (v/v)
Glycerol 1.45% (v/v) Glycerol 1.45% (v/v)
Hydrogen Peroxide 0.125% (v/v) Hydrogen Peroxide 0.125% (v/v)
Distilled water 18.425% (v/v) Distilled water 23.425% (v/v)
(Above mentioned are the final concentrations of the formulations.)
Many local manufacturers and pharmacies are already using theses WHO formulations,
following the guidance available on official WHO website.
For healthcare settings, Centers for Disease Control and Prevention (CDC) recommends
using alcohol-based hand rub (ABHR) with ethanol more than 60% or isopropanol more
than 70%.
CDC recommends use of EPA-registered household disinfectant and has issued List N:
Products with Emerging Viral Pathogens AND Human Coronavirus claims for use against
SARS-CoV-2 (containing 469 entries with latest update on 30th
July 2020).
3. FDA Classification for Disinfectants
I. Chemical/Physical Disinfectant devices:
II. Ultraviolet (UV) Disinfecting Devices:
o Class II devices under 21 CFR 880.6600 (product code OSZ)
o Uses UVA or UVC light to produce a germicidal effect.
These devices are classified under medical device classification and require submitting
a premarket notification (510(k)) submission to FDA before introducing them to in
market.
FDA has issued Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency in March
2020. To receive a copy of guidance, one can send an email request to CDRH-
Guidance@fda.hhs.gov
As declared by, Department of Health and Human Services (HHS), this policy is intended
to be in effect on for the duration of public health emergency related to Covid-19.
Although, in normal condition, manufacturer or supplier must complete the premarket
notification 510(k) submission process, as follow:
Classification
Regulation
Device Type
Product
Code
Device Classification
21 CFR 876.1500
Cleaning accessories for
endoscope
FEB II
21 CFR 880.6885 Medical devices sterilant MED II
21 CFR 880.6992
Medical devices
disinfectors
MEC
II (exempt from premarket review unless
indicated for high level disinfection or for
use on endoscopes and accessories)
21 CFR 880.6992 Medical devices cleaners MDZ II
21 CFR 892.1570
High level disinfection
reprocessing instrument
for ultrasonic
transducers, mist
OUJ II
21 CFR 892.1570
High level disinfection
reprocessing instrument
for ultrasonic
transducers, liquid
PSW II
4. Manufacturer/Supplier must meet the requirement of 510(k) submission. Before marketing a device, each submitter must
receive an order, in the form of a letter, from FDA which finds the device to be Substantially Equivalent (SE) and states that
the device can be marketed in the US. This order “clears” the device from commercial distribution.
A 510(k) submission must be submitted in an electronic format (eCopy), should be sent to CDRH’s or CBER’s
Document Control Center (DCC), which is available on eCopy Program for Medical Device Submissions
When the DCC receives the 510(k) submission, it assigns the submission a unique control
number "510(k) number," or "K number", begins with K followed by 6 digits
If the proper user fee has not been paid and/or a valid eCopy has not been provided, then the
DCC will email a Hold Letter to the 510(k) submitter, usually within 7 days of receipt of the
510(k). Submitter needs to resolve it within 180 days. If not resolved, it will be considered as
withdrawn and has to submit new 510(k) FDA marketing clearance
After the Acknowledgement Letter is sent, the DCC routes the 510(k) to the appropriate ODE or
OIR Division
Within 15 days of the receipt of the submission, the submitter will receive an electronic
notification of the Acceptance Review result, which will: Identify name & contact information of
FDA Lead Reviewer and Indicate the status
If the Lead Reviewer sends an AI (Additional Information) Request, the submission is placed on
hold. The submitter must submit the response, with a valid eCopy, to the DCC within 180
calendar days of the date of the AI Request; including the submitter’s name; 510(k) number;
identify the submission as Additional Information (AI) to the 510(k); date of FDA's request for AI
and provide the requested information in an organized manner
When a decision is made, FDA will issue the decision letter to the submitter by email to the email
address provided in the 510(k) cover letter. A 510(k) that receives an SE decision is considered
"cleared." And submitter will be added in the 510(k) database, which is updated weekly.
The 510(k) Submission Process
By Day 1
•FDA
receives
510(k)
submission
By Day 7
•FDA Sends
Acknowledgement
Letter OR
•FDA Sends Hold
Letter if
unresolved issue
with User Fee
and/or eCopy
By Day 15
•FDA conducts
Acceptance
Review
•FDA informs
submitter if
510(k) is
accepted for
Substantive
Review or
placed on RTA
Hold
By Day 60
•FDA conduct
Substantive Review
•FDA communicates
via Substantive
Interaction to inform
the submitter that
the FDA will either
proceed with
Interactive Review or
that the 510(k) will be
placed on hold and
Additional
Information is
required
By Day 90
•FDA sends
final MDUFA
(Medical
Device User
Fee
Amendments)
Decision on
510(k)
By Day 100
•If MDUFA
Decision is not
reached by Day
100, FDA
provides missed
MDUFA
Decision
communication
that identifies
outstanding
review issues
FDA Process Timeliness
5. Hand Sanitizers under FDA
Hand sanitizers are regulated as over-the-counter (non-prescription) drugs by the U.S.
Food and Drug Administration.
Hand Sanitizer Registration process with the FDA:
Generally, Hand Sanitizer FDA registration may take approximately 14-20 days working
days. NDC (National Drug Code Directory) number may consume maximum time around
7-14 days, once requested with FDA.
To help meet the increased demand for hand sanitizers during the COVID-19 public
health emergency, FDA has published three guidances. During this pandemic, entities
which are currently not registered as drug manufacturers can register over-the-counter
(OTC) drug manufacturers and make alcohol-based hand sanitizers, pharmacies and
registered outsourcing facilities can compound the alcohol-based hand sanitizers and
alcohol manufacturers can produce alcohol for sanitizers, by following the conditions
outlined in the FDA guidances for industry.
The guidance copies are available on official FDA website, and can also be requested on
mail to druginfo@fda.hhs.gov or COVID-19-Hand-Sanitizers@fda.hhs.gov
Also, FDA is testing the quality of different hand sanitizers used by the public and found
many of them containing methanol, or wood alcohol – which is used to create fuel and
not acceptable active ingredient for hand sanitizer, as they can be toxic when absorbed
through skin and can be life threatening if ingested.
FDA is warning not to use hand sanitizer from the list of companies mentioned on
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-
consumers-should-not-use
1.
Assess the list of
active Ingredients
2.
Determine
Registration Pathway
3.
Assess of Label
Compiance
4.
Request NDC code &
Labeler code from
FDA
5.
Register the
manufacturer
establishment with FDA
6.
List the Drug with
FDA
6. EU Standards
Hand disinfectants (soap, gel, wipes) are considered Biocides in Europe.
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) replaced the Biocidal
Products Directive (BPD) also known as the Biocides Directive is European Union
Directive, (98/8/EC), and officially known as Directive 98/8/EC of the European
Parliament and of the Council of 16 February 1998 concerning the placing of biocidal
products on the market.
The Biocides are classified as (according to Annex V):
•Product-type 1: Human hygiene biocidal products
•Product-type 2: Private area and public health area disinfectants and other biocidal products
•Product-type 3: Veterinary hygiene biocidal products
•Product-type 4: Food and feed area disinfectants
•Product-type 5: Drinking water disinfectants
Group 1
Disinfectants and general biocidal products
•Product-type 6: In-can preservatives
•Product-type 7: Film preservatives
•Product-type 8: Wood preservatives
•Product-type 9: Fibre, leather, rubber and polymerised materials preservatives
•Product-type 10: Masonry preservatives
•Product-type 11: Preservatives for liquid-cooling and processing systems
•Product-type 12: Slimicides
•Product-type 13: Metalworking-fluid preservatives
Group 2
Preservatives
•Product-type 14: Rodenticides
•Product-type 15: Avicides
•Product-type 16: Molluscicides
•Product-type 17: Piscicides
•Product-type 18: Insecticides, acaricides and products to control other arthropods
•Product-type 19: Repellents and attractants
Group 3
Pest control
• Product-type 20: Preservatives for food or feedstocks
• Product-type 21: Antifouling products
• Product-type 22: Embalming and taxidermist fluids
• Product-type 23: Control of other vertebrates
Group 4
Other biocidal products
7. Authorisation Process:
The authorisation of biocidal products takes place in two consecutive steps:
1. Active Substances
Such as Ethanol, propanol, chlorhexidine, chlorine, quaternary ammonium compounds,
used in a biocidal product must be assessed positively for safety & efficacy.
• Assessments evaluations are to be completed by the Competent Authorities of
the Member State (MSCA) or the European Chemical Agency (ECHA), and then
approved by the European Commission for a specific Product Type (PT)
• According to Article 95 of the BPR, companies placing the active substance on the
market needs to make sure either ‘substance supplier’ or ‘product supplier’ must
be in the list of approved active substances and suppliers published by ECHA.
2. Biocidal Product containing Active Substance
Before being used or sold in the market, biocidal products must be authorised by Competent
Authorities (MSCA or ECHA). And the active substance contained by it must be previously approved.
There are two types of biocidal product authorisation processes
depending on the approval status of the active substance in it:
Pending approval for active substance
With subject to national registration granted
by the relevant Member State, Biocidal
products containing active substances which
are currently in Review Programme can be
made available and used in EU market.
For eg., ethanol-based hand sanitizer
Approved active substance
The biocidal product with approved active substance
in Review Programme with specific product type,
must be authorised according to the procedures and
requirements mentioned in the BPR.
For eg., sodium hypochlorite-based hand sanitizer
(chlorine released)
The national Competent Authority or ECHA can authorise a disinfectant if:
• The active substance is under review or approved for relevant PT
• The product is effective for its intended use(s)
• The product and its usage is safe for animal, human and environmental health
• Efficacy claims such as Antibacterial, Disinfectant, Fight germs, Kills 99% bacterial,
etc. must have been supported by the testing
8. Contact Us
EUROPEAN Offices
Dragon Sourcing Paris
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Tel::+33 (0)7 50 65 09 23
Email: bonjour@dragonsourcing.com
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08012 Barcelona, Spain
London, W1U 6PZ, UK
Tel:+ 34 689 87 09 02
Email: hello@dragonsourcing.com
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Moscow, 108801,Russia
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Dragon Sourcing Turkey
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Nilufer Bursa, Turkey
Tel: +90 505 506 86 76
Email: merhaba@dragonsourcing.com
ASIAN Offices
Dragon Sourcing Shanghai
Suite 1502-1503, Jin Tian Di International Mansions
998, Renmin Road – Shanghai, 200021, P.R.China
Tel: +86 21 61 41 39 55
Fax: +86 21 61 41 39 66
Email: contact.asia@dragonsourcing.com
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148 Connaught Road Central, Hong Kong
Tel:+852 91 80 40 57
Fax: +852 25 80 24 26
Email: contact.asia@dragonsourcing.com
Dragon Sourcing Vietnam
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Email: hello@dragonsourcing.com
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Tel: +966 11 810 2252
Email: hello@dragonsourcing.com
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Andheri West, Mumbai – 400053
India
Email: contact.india@dragonsourcing.com
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Email: contact.hello@dragonsourcing.com
NORTH AMERICAN Office
Dragon Sourcing Houston
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Missouri City, TX 77459
Phone: 832- 406-0281
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LATIN AMERICAN Offices
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4800, Tower II Office 102 Floor 1
SANTA FE CUAJIMALPA, MEXICO CITY,
Phone +52 312 1217217
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