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Required Documents for Class C & D Medical Device to Grant Manufacturing Permission

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Required Documents for Class C & D Medical Device to Grant Manufacturing Permission

The Central Drugs Standard Control Organisation (CDSCO) supervises the manufacturing of notified medical devices in India. This regulatory body handles granting licenses and approval of the manufacturing of medical devices.

The manufacturer must apply for the Grant of License to sell and distribute Class C and D Medical devices. As per the Medical Devices Rules (MDR), 2017 provisions, CDSCO grants license approval for manufacturing Class C or D Medical devices in Form MD-9. 

For obtaining manufacturing permission, device master file, site master file, and quality management system documents are necessary.


Forms Required for Class C D Medical Device Manufacturing Permission

Two forms are essential for availing the manufacturing approval of medical devices. The forms are as follows:

Form MD-7: The application form required to be submitted for a manufacturing license

Form MD-9: The License obtained for the manufacturing of Class C or D Medical device


Eligibility and The Process of Medical Device Manufacturing Application

Any individual who wishes to manufacture Class C and D Medical Devices can apply to the Central Licensing Authority via Form MD-7. In addition, the applicant can submit the application forms via an online portal of the Central Government.

The documents mandatory during the application process are listed in table 1. The applicant must prepare the technical documents carefully per the latest MDR guidelines. Failure to do so may cause in postponement in submission or other problems. 


List of documents required

  • Cover letter 
  • Device and site master files
  • The establishment, tendency, and site ownership agreement of the firm 
  • Quality Management System Documents which are specified as per the 5th schedule of Medical Device Rules and performance evaluation report (Only in vitro diagnostic device)
  • Valid copies of the Quality Certificate of the manufacturing site (Should be duly notarized)
  • Valid Test License (for the testing and generation of quality control data)
  • A signed undertaking which should state that the provisions of the Fifth Schedule are being followed



Government Fee for Class C D Medical Device Manufacturing

The government charges for one Class C or D Medical Device manufacturing device is 50000 INR, whereas the cost for each distinct medical device is 1000 INR.


Inspection for issuing Form MD-9 license

After the individual submits Form MD-7, CDSCO will review the application. This can be followed by an inspection of the manufacturing site, which is done by Medical Device Officers or a Notified body. The inspection will be conducted within 60 days from the date of application. An expert may or may not accompany Medical Device Officers or a Notified body during the examination. 

Based on the results obtained during the inspection, CDSCO may grant the license in Form MD-9. The license is granted within 45 days after receiving the inspection report.


Validity of the Medical Device Manufacturing License

The Form MD-9 license does not have a fixed time for expiry. This license can be valid forever; however, as per the Second Schedule, the license retention fee must be paid promptly within five years of the issue date. 

If the license holder does not make timely payments, the license will get cancelled or suspended.



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Paulmark 2022-05-24
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Use Healthcare Mailing’s Medical Distributor List for market research and learn about your audience. Keeping our Medical Device Distributors List GDPR-compliant and opted-in effectively increases your email deliverability and reduces bounce rates. Our Medical Device Distributors Email List is segmented geographically for easy reference, and further customization is done based on your requirements. Our Medical Device Distributors Mailing List integrates easily into your CRM at no further cost. View our related lists- ·        Email List of Medical Device Vendors Database ·        Surgical / Medical Instruments Email List              ·        Spinal devices Distributors Email List·        List of Medical Device Manufacturing Companies             ·        Durable Medical Equipment Mailing List               ·        Neuro-modulation Devices Distributors EmailsWhen you consistently reach out to prospects on our Email List of Medical Device Distributors, they will want to know more about your products, visit your website, sign up for your list, and get closer to lead conversion.
Information about CDSCO Import License For Medical Device
Jassy Sam 2022-09-21
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As per the new Guidance of CDSCO, suspense and cancellation of the Class A & B medical devices may be if importer fails to meet the deadline specified by CDSCO. This procedure is applicable when we import medical devices from other countries to India. Speed up your import licensing process with us; Operon Strategist will assist you at every step of medical device importing license. 29/ Misc/ 03/ 2021- DC( 28) on April 18th, 2021 the Central Drugs Standard Control Organization( CDSCO) now requires the following medical devices gain an Import License previous to importation. All Implantable Medical Devices CT Scan Equipment MRI Equipment Defibrillators PET Equipment Dialysis Machines X-Ray Machines Bone Marrow Cell Separators CLASSIFICATION OF MEDICAL DEVICES The medical devices are classified into the following 4 orders based on the risk involved in operation Class A – low risk Class B – low to moderate risk Class C – moderate to high risk Class D – high risk The devices are further classified into Surgical andNon-Surgical based on their invasiveness.
Medical Device Testing Market Industry Analysis, Size, Share, Growth and Forecast To 2029
Data Bridge Market Research 2022-03-22
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The Medical Device Testing Market Scope and SizeWhile generating this finest Medical Device Testing Market research report, marketing administration has taken into account the minds of their target markets, their feelings, their preferences, their attitudes, convictions and value systems with a formalized and managerial approach. Global Medical Device Testing Market report estimates CAGR values in percentages which designate the rise or fall occurring in the market for particular product for the specific forecast period. The scope of this Medical Device Testing Market research report involves industry research, customer insights, market sizing and forecast, competitive analysis, market entry strategy, pricing trends, sustainability trends, innovation trends, technology evolution, and distribution channel assessment. com/reports/global-medical-device-testing-marketKey Players Medical Device Testing MarketCharles River Laboratories International, Inc. , TÜV RHEINLAND, UL LLC, Eurofins Scientific, ASTM, Element Materials Technology, Avomeen, Gateway Analytical among other domestic and global playersMAJOR TOC OF THE REPORTChapter One: Medical Device Testing Market OverviewChapter Two: Manufacturers ProfilesChapter Three: Medical Device Testing Market Competition, by PlayersChapter Four: Medical Device Testing Market Size by RegionsChapter Five: Medical Device Testing Market Revenue by CountriesChapter Six: Medical Device Testing Market Revenue by TypeChapter Seven: Medical Device Testing Market Revenue by ApplicationChapter Eight: Medical Device Testing Market Revenue by IndustriesChapter Nine: Medical Device Testing Market Revenue by Deployment ModelChapter Ten: Medical Device Testing Market Revenue by End UserGet TOC Details: https://www.
Global Medical Device Reprocessing Market Report 2024: Growth Rate, Major Segments And Regions
saikiran TBRC 2024-03-02
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Learn More On The Medical Device Reprocessing Market:https://www. The medical device reprocessing market size is expected to see rapid growth in the next few years. An increase in surgical procedures is expected to propel the growth of the medical device reprocessing market going forward. Major companies operating in the medical device reprocessing market are adopting new technologies to sustain their position in the market. The medical device reprocessing market report table of contents includes:1.