Ozg Healthcare Projects

07/12/2020

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the Food and Drug Administration of the United States (FDA) it is a plan announced by the way government to bring all medical devices, including implants and contraceptives, under the view of the Central Drugs and Standard Control Organization (CDSCO).

manufacturing license of medical devices is covered under CLAA scheme and signed for granting by State Licensing Authority may be considered for approval by CLAA with the condition that licensee shall fulfill requirements of Medical Devices Rules. Manufacturing of notified medical devices comes under the CLAA scheme for sale in India, in manufacturing license in Form -28 is required under drugs and cosmetics rule is required for grant of manufacturing license.

Phase I – Applicant Registration:

In thisphase after applying client can have an active account on CDSCO Online System for Medical Devices registration site.

Document requirements:

Documents required for this phase are address proof like certificate of registration or certificate of incorporation or Import-export certificate or any bills of corporate site, ID proof of authorized person, this person can be any person apart from management team who will be authorized to all types of registration. Also, if client is having whole sale license or manufacturing license thenself-attested copy has to be submitted and in absence of any of these licenses then justification on company letter head stating the same.

Procedure:

First online form has to be filled and all above required documents have to be uploaded. In online form details of manufacturing company like complete corporate address, contact details like email and contact No., fax No., name of authorized person name, ID proof number, Company type (Ltd, Pvt. Ltd etc.), email id for registration, password, alternate email id etc.

Once form submitted, preliminary approval mail will be received from CDSCO then another mail stating hard copy submission will be received. Hard copies of all uploaded documents have to be couriered to CDSCO address with specific subject mentioned in that mail.

Hard copies submitted will be verified with online submitted information and documents and then CDSCO will approve application registration. Mail will be received from CDSCO after approval to verify log in details and hence online account will be generated.

If rejection of application happened from CDSCO for submitted application then mail will be received stating reason for rejection then revised document have to be submitted during reapplication and same process have to follow again.

Phase II – Testing License application

This license is required to have permission to manufacture small quality of device for testing, evaluation, demonstration and training of personnel.

Procedure:

For Application on online portal, form has to be filled with device related information like generic name, brand name, class of device, category of device, packaging configuration, shelf life, sterile / non-sterile, intended use, product description, accessories and model details if any.

After form filling, uploading of all above documents to be done. Then payment as per fee structure of CDSCO has to be done online. Download the legal pdf form. Put digital signature and then again upload this form for final submission of application. Once application is successful firm will receive mail from CDSCO.

Application submitted will be moved to stage of In-process when review is in-process. Then either application can be approved or if any query raised then that query related revised documents or any justification for that have to be uploaded online against that query.

Phase III – Manufacturing license application

This license is required to have permission to manufacture device for commercial purpose.

Procedure:

For Application on online portal, form has to be filled with device related information like generic name, brand name, class of device, category of device, packaging configuration, shelf life, sterile / non-sterile, intended use, product description, accessories and model details if any.

After form filling, uploading of all documents to be done. Then payment as per fee structure of CDSCO has to be done online. Upload payment receipt on online poral then a legal form will be generated based on product information filled and transaction done. Download the legal pdf form. Once application is successful firm will receive mail from CDSCO.

Application submitted will be moved to stage of In-process when review is in-process. If query compliance is acceptable then approval of test license will be received and email related to same will be send by CDSCO. Then after visiting portal cover and permission letter can be downloaded.

07/12/2020

What is FDA 510 k Clearance?

Every device manufacturer who wish to trade in the US market for the classified medical device Class I, II, and III. Premarket approval application (PMA) is not necessary if those are meant to human use. But must submit FDA 510 k unless the device is exempt from 510 k necessity of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), and does not overreach the circumstance of exemptions of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).

FDA 510k is a premarket approval process made by FDA to signify that the device to be marketed is at least as safe and effective, substantially equivalent, to a lawfully marketed device (21 CFR 807.92) that is not subject to premarket approval. The appliers must measure their medical device to one or more similar legally marketed devices to support their substantial equivalency claims. And important to note that FDA does not execute 510 k pre-clearance facility inspections. The appliers may market their device immediately after 510 k clearance is permitted at any time after FDA 510 k clearance.

The FDA does not “approve” FDA 510 k submissions. It “clears” them. It is not legal to advertise a 510(k) cleared device as “FDA-approved.

510 k clearance

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k).

US FDA 510k certification

Types of 510(k)

There are typical 3 types of 510(k) established under the US FDA clearance system. The Traditional Program is the original submission type as provided in 21 CFR 807. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of

certain types of submissions subject to 510(k) requirements. These Programs were previously described in The New 510(k) Paradigm guidance. In 2019, the FDA split “The New 510(k)

Paradigm guidance into two distinct guidance documents: The Special 510(k) Program and The Abbreviated 510(k) Program. The Special 510(k) and Abbreviated 510(k) submission types can be used when a 510(k) submission meets certain factors.

Traditional 510(k):

This type of 510(k) is what is known as the original 510(k) submission or for a change/modification done to a previously cleared device under 510(k). This may be used under any circumstances.

Abbreviated 510(k):

This type of 510(k) is when the submission relies on:

FDA guidance document(s),
Demonstration of compliance with special control(s) for the device type, or
Voluntary consensus standard(s).
Special 510(k):

This type of 510(k) is considered when there is modification to a device however modification should have no effect on intended use or alter the fundamental scientific technology. Examples for these modifications can include:

Change in environmental specifications
Change in performance specifications
Change in ergonomics of the patient user interface
Dimensional specifications
Software or firmware
Where to start US FDA 510 k clearance Process.

FDA 510 k service is an online process, starts from classifying the devices & gathering information about the company products and then uploading them, through an online process. For class II devices, there is a process called the US FDA 510 k process or the pre-market clearance. In this, the safety & effectiveness of the device is established through substantial equivalence.

Who needs FDA 510 k and Why?

The domestic medical device manufacturers from any country trying to introduce a new device to the US market. Re-packers or Re-labellers who make labelling changes or whose operations significantly affect the device. In simple words, FDA 510 k is the name of a process, but technically it is a complicated and equally important process to submit your device documentation for clearance, To determine whether the device is safe and effective and hence permissible to legally sell in USA market.

Device identifications point for FDA 510 k

A device is considered identical only if, in comparison to a predicate it.

The device has to have the same intended use as the predicate; and
Also, the device should have the same technological characteristics as the predicate;
Deliberate use should be remaining the same as the predicate
Whether the device has different technological characteristics and does not raise different questions of safety and effectiveness
The data submitted to the FDA reveals that the device is at least as safe and effective as the legally marketed device.
FDA 510 k medical device approval process

State of considerable equivalence does not mean the new and predicate devices must be identical. Significant equivalence is established with respect to the intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards and other characteristics, as applicable. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the US market.

Preparation for FDA 510 k Application

Anyone who wants to sell a device in the U.S. It is required to make the US FDA 510 k submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. Change in the intended use of a device which you already have in commercial distribution. If there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness. A new US FDA 510 k submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different indication for use. The medical device manufacturer which makes the products GMP non exempted are expected to implement the 21 CFR Part 820 as a quality management system.

The products which are marked as GMP Non-exempted, the quality management system as per 21 CFR Part 820. The US FDA 510 k submission shall be prepared and submitted along with the review fees, the US FDA 510 k review fees can be remarkably reduced based on the turnover. The entities including its affiliates shall have less than 100 million dollars turnover to be qualified as SBU (Small Business Unit). The review is conducted by CDRH (Centre for Devices and Radiological Health) and raise queries if any. After successful completion of the activity, the US FDA 510 k number is approved. After US FDA 510 k approval, the Establishment registration and device listing shall be done in order to supply products in the US.

What is an Acceptance Review?

Once Acknowledge letter is sent to submitter the DCC routes to appropriate ODE or OIR division and the Lead Reviewer conducts the Acceptance Review

Assess if 510(k) is administratively complete using acceptance checklist
Acceptance review usually results in:

The 510(k) was accepted for substantive review; or
The 510(k) was not accepted for review (i.e., considered refused to accept or RTA); or
The 510(k) is under substantive review because FDA did not complete the acceptance review within 15 calendar days.
The submitter has 180 calendar days to fully address the deficiencies cited in the RTA Hold. If this is not done, the 510(k) is considered withdrawn and deleted from our review system. If the 510(k) is deleted, the 510(k) submitters will need to submit a new, complete 510(k) to pursue FDA marketing clearance for that device.

18/07/2013

FCNR (B) loans - The borrower is not required to go to the International market for raising the funds as foreign currency funds are made available in India reducing the cost of raising such funds. Get more info @ http://fundraising.ozg.in/2013/07/fcnr-b-loan-consultant-for-business-ecb.html

03/06/2012

www.facebook.com/Ozg.Center

Follow 🩷 ODFC Digital (INDIA)
Visit Website: 🖥️ odfcdigital.com
Gaming 🎯 Forex/Trading 🎯 Mining

28/11/2011

The United States Agency for International Development (USAID) in Ukraine is seeking grant proposals from NGO or for-profit nongovernmental organizations (NGOs) to assist in implementation of Improved HIV/AIDS Services among Most-at-Risk Populations (MARPs) in Ukraine. READ MORE - http://healthcare.ozg.in/2011/11/usaid-ukraine-hiv-aids-program.html

The United States Agency for International Development (USAID) in Ukraine is seeking grant proposals from NGO or for-profit nongovernmental organizations (NGOs) to assist in implementation of Improved HIV/AIDS Services among Most-at-Risk Populations (MARPs) in Ukraine. USAID plans to provide a maxim...

23/10/2011

The 24/7 Services for Legal, Financial & Technical Documents.

20/10/2011

Tech-Law Solution 24/7

18/10/2011

India wants to be a preferred destination for medical tourism, but its health care offering for its own citizens is lacking. The doctor-to-population ratio for the country is 6:10000, compared to a global ratio of 14:10000. It is estimated that over the next two decades, India will need twice as man… -- http://healthcare.ozg.in/2011/10/state-of-health-care-in-india.html

India wants to be a preferred destination for medical tourism, but its health care offering for its own citizens is lacking. The doctor-to-population ratio for the country is 6:10000, compared to a global ratio of 14:10000. It is estimated that over the next two decades, India will need twice as man...

18/10/2011

The rate of growth of the health care industry in India is moving ahead neck to neck with the pharmaceutical industry and the software industry of the country. Much has been said and done in the health care sector for bringing about improvement. Till date, approximately 12% of the scope offered by t… -- http://healthcare.ozg.in/2011/10/health-care-industry-in-india.html

The rate of growth of the health care industry in India is moving ahead neck to neck with the pharmaceutical industry and the software industry of the country. Much has been said and done in the health care sector for bringing about improvement. Till date, approximately 12% of the scope offered by t...

18/10/2011

An assessment of the health status and health problems is the first requisite for any planned effort to develop health care services. This is also known as community diagnosis. Healthcare in India features a universal health care system run by the constituent states and territories of India. The Con… -- http://healthcare.ozg.in/2011/10/health-status-and-problems-in-india.html

An assessment of the health status and health problems is the first requisite for any planned effort to develop health care services. This is also known as community diagnosis. Healthcare in India features a universal health care system run by the constituent states and territories of India. The Con...

18/10/2011

The advent of cheaper sensors and wireless transmitters, along with ubiquitous computing power in the form of smart phones, is making it easier and easier for patients with chronic diseases to track their conditions at home. But many health-care providers seem reluctant to adopt these technologies. -- http://healthcare.ozg.in/2011/10/how-healthcare-sys-slows-mobile-medical.html

The advent of cheaper sensors and wireless transmitters, along with ubiquitous computing power in the form of smart phones, is making it easier and easier for patients with chronic diseases to track their conditions at home. But many health-care providers seem reluctant to adopt these technologies.

18/10/2011

Health is undeniably one of the most precious assets of human beings. Unfortunately, the contemporary lifestyles and unhygienic environmental exposures have put the health of human beings at stake. Emergence of different types of medical disorders has subsequently rendered potentially harmful conseq… -- http://healthcare.ozg.in/2011/10/health-insurance-plan-in-india.html

Health is undeniably one of the most precious assets of human beings. Unfortunately, the contemporary lifestyles and unhygienic environmental exposures have put the health of human beings at stake. Emergence of different types of medical disorders has subsequently rendered potentially harmful conseq...