www.corpzo.
com
Easing Compliance
Incubating Growth
COMPLIANCE | FINANCE | LEGAL | INVESTMENT | GROWTH | ENVIRONMENT
www.corpzo.com
MD-15
Licence to import medical
devices in INDIA
Business licence
ACCELERATING BUSINESS EVOLUTION
ABOUT US
✓ We are a Corporate Compliance organization having our presence across the globe aiming to ease compliance
and assist in business evolution.
✓ We ensure that your business is up to pace with todays hyper-dynamic corporate legal structure(s)
✓ We take care of your compliance, so you can focus on your business.
✓ We are a corporate compliance organisation with expertise at providing pollution related and waste
management advisory.
✓ Our experts have facilitated the incorporation of more than 1000 clients.
✓ We have facilitated more 5000+ clients in attainment of there business licences and registrations and more than
300 clients in obtaining there Ayush Manufacturing Licences throughout India.
✓ Successfully executed 20+ MD-15 Licence applications throughout India.
Corpzo VISION & mission
OUR VISION is to simplify the compliance, accounting and OUR MISSION is to make the business journey simpler, more
tax regime for SME’s and emerging corporates and pleasant and growth oriented for SME’s and emerging corporates by
remove growth barriers by efficient and bespoke solutions helping them steer through finance, compliance and legal challenges
aimed at unlocking the full potential of the business. We in the smoothest manner possible. We are experts at helping
are set out to become one of the most preferred and startups in:
accessible advisory group for SME’s and emerging
corporates of India ✓ Mentoring support
✓ evaluating the business idea and creating business plan
✓ concept to commissioning of projects
✓ setup of your business
✓ Regulatory Compliance Support
✓ regular accounting management and book-keeping
✓ complete finance, compliance management
✓ bespoke accounting and auditing solutions
✓ Tax planning and management
✓ attainment of registrations, licences and approvals
✓ business process management
What is MD-15 license?
The new regulatory framework published by the Central Drugs Standard Control Organization (CDSCO) has developed
new guidance documents or legal documents for the registration and re-registration of notified medical devices. Those
legal guidelines were drawn up on the basis of the 2017 regulations on medical devices, which legally came into force on
11 January 2018. CDSCO is authorised for approving the application for permission to import medical devices in India,
Import, Distribution And Registration Of Medical Devices In India.
Any approved agent who already holds a license to manufacture, sell or distribution medical devices in India can apply for
an approval for importing medical device in India. In addition, any wholesaler who wishes to import medical devices for
sale and transfer shall also apply for an import license.
An importer of Rapid test kits for Corona Virus or Covid-19 strain needs to mandatorily apply for permission for import
of such kits. Any foreign manufacturer willing to supply test kits for corona virus in India will need to avail this
permission for import in MD 15.
The licensing process is governed by the Ministry of Health and Family Welfare of the Central Government. The Ministry
has an electronic portal from which an application for an import license has to be made. The application shall be made to
the Central Licensing Authority using Form MD-14 only by person having a valid wholesale or manufacturing drug licence.
APPLY NOW
Pre-requisites for MD-15 approval
✓ AREA:
The minimum area for obtaining a MD-5 approval should be a commercial space having a minimum area of 15 square
meters.
Wholesale drug licence:
✓
The first step towards importing a medical device in India is procuring a Wholesale Drug License (WDL) which is issued to
a person who is engaged in the business of wholesale drugs and medicines. Read More
✓ Import export code:
Any type of import or export activity in India cannot be carried without having a valid import export certificate issued by
the Director general of Foreign Trade. Read More
Documents of manufacturer for md-15 approval
1. Details of the product intended to be imported the devices are of a good quality.
2. Details of Manufacturing Site (Foreign Manufacturer) 14. Device Master as per Appendix II of Medical Devices Rules 2017 File specifying
3. Power of Attorney technical, clinical and safety related information and test data of the medical
4. Notarized copy of ISO 13485 Certificate device being imported.
5. GMP Certificate 15. A plant master file/quality manual as per specified in Appendix 1 of the
6. Notarized CE Design Certificate Forth Schedule of the Medical Devices Rules
7. Declaration of conformity 16. Batch Release Certificate
8. PMS Report 17. Device Master File for Medical Devices
9. Business Licence/Plant Registration Certificate 18. Detailed test report of all components used / packaged in the finished in
10. Software verification and validation if software is used medical device, package size and labelling, product inserts.
11. Latest Inspection Report or Audit Report carried out by notified bodies or 19. Detailed evaluation report, if carried out by any laboratory in India,
national regulatory authority or competent authority within last 3 years showing the sensitivity and specificity of the in vitro diagnostic medical
12. Free Sale Certificate (FSC) (Notarized/Apostilled, as applicable) device and basic processing specifics such as safe handling, material
13. Full Quality Assurance Certificate of the Foreign Manufacturers to ensure that control, area control, process control, etc.
In case any further information or document is required, Our Compliance team will collect the same within 7 days begin the process.
Documents of importer for md-15 approval
1. A Cover Letter in proper format mentioning the following details:
a. a. Details of the Intended product
b. b. Details of Manufacturing Site (Foreign Manufacturer)
2. Power of attorney
3. TR6 challan (custom duty paid)
4. GMP certificate (Indian Entity)(We can help with this)
5. ISO (Indian Entity/Importer) (We can help with this)
6. Audit report (Past 3 financial years)
7. Test Report of the product by an Indian Lab.
8. Self attested copy of Wholesale Drug Licence
In case any further information or document is required, Our Compliance team will collect the same within 7 days begin the process.
Documents for Wholesale drug Licence
Following Documents of the Indian Entity (IMPORTER) shall be required: ✓ The affidavit from the Regd. pharmacist/competent person (System
✓ Online fee deposit receipts. Generated)
✓ Application Form No. 19/19A/19B/19C as applicable (System Generated) ✓ For proof of premises:
✓ Layout plan and key plan of the premises. o Regd. Sale Deed / Regd. GPA / Conveyance Deed or Electricity Bill /
✓ MOA & AOA along with Copy of resolution Passed, in case of the company. Water Bill/property tax receipt Along with GPA in the name of the
✓ Deed of partnership, duly attested by Notary Public, in case of the owner if the property is owned
partnership firm. o Rent Receipt and either Regd. Rent Agreement, or Unregistered
✓ Trust deed, in case of trust/society. Rent Agreement along with ownership documents of the landlord,
✓ Photo ID proof of proprietor/partner/director of the firm. as stated above, in case of rented premises
✓ Affidavit regarding non-conviction of Prop./Partner/Director as well as the ✓ Documents of Technical Staff:
firm under Drugs & Cosmetics Act, 1940. o Proof of qualification i.e. final degree certificate / provisional
✓ Affidavit regarding the compliance of MPD 2021. certificate with mark sheets
✓ Registration / Conversion charge /Parking charge receipt issued by MCD o Experience Certificate,
with relevant documents in support of commercial use as per MPD 2021 o Appointment Letter, and Bio-data.
viz; document indicating the Name of notified commercial / mixed-use
road/street.
In case any further information or document is required, Our Compliance team will collect the same within 7 days begin the process.
Process flow for MD-15 approval
The first step towards importing a medical device in India is
procuring a Wholesale Drug License (WDL) which is issued to a
01 Wholesale Drug licence person who is engaged in the business of wholesale drugs and
medicines.
The documentation of MD-15 is a bit extensive in nature. Hence,
02 Collection of documents we prefer to collect all the requisite documents from the foreign
manufacturer parallelly with the filing of wholesale drug licence
Import of medical devices in India is regulated by the CDSCO
and a permission from the CDSCO is to be obtained before
03 Md-15 Licence importing any type of medical device(s) in India including but
not limited to predicate IVD kits, Masks etc.
Steps for MD-15 License
Collection & Verification of Soft Copy of all
the relevant Documents & Information
including brand name, logo and business
Review of the duly signed and executed activity.
Documents by our experts and request for
additional information/documents
Preparation of
draft Our team scrutinizes the documents and
prepares the draft application in form MD-14 for
the approval of MD-15 Licence and requisite
attachments as may be needed
FILE SUBMISSION
Submission of application for MD-15 Approval
along with the attachments and prescribed fees
post which the Challan is generated.
APPROVAL
The file is meticulously scrutinized by the
designated officers which may be followed by a
site inspection of the Unit by the
MD-15 is issued by the departments within designated/authorised officer of the department
a period of 45-60 working days after
successfully reviewing your application and
conducting a site inspection.
SCOPE OF WORK
END TO END Advisory for Medical Device import and Ensuring compliance with the essential norms
✓ trade ✓ prior to submission of application
Preparation of the application in consonance with Assistance in preparation/compilation of all the
✓ the your team and requirements ✓ necessary documents and attachments
✓ Submission of MD-14 Application and prescribed fees ✓ Pro-active follow up with the designated officer
RELATED SERVICES
PRIVATE LIMITED COMPANY REGISTRATION
01
ANNUAL FILING
02
ACCOUNTING & BOOKKEEPING
03
FINANCIAL ADVISORY
04
DRUG LICENCE
05
BUSINESS LICENCES
06
Our Services
01 Business Strategy Compliance Management
05
o Business Plan o Annual Compliance
o Startup Pitch Deck o Periodic Filing and Returns
o Feasibility Analysis o Change in Business
o Techno Economic Evaluation o FERA & FEMA
o Listing Compliance
Business Incorporation Environment Approvals
02
o
o
Indian Business Incorporation 06 o Pollution Noc/Consent
International Incorporation o EPR Authorisation (E-waste & Plastic)
o Foreign Subsidiary / India Entry Steps to a o Bio Medical Waste
o Financial Business Incorporation o Solid Waste
o NGO Incorporation Successful o Hazardous Waste
o Joint Ventures/Speacial Purpose Vehicles o CGWA NOC
o Trust/ Society/ Section 8/ NGO Business Financial Advisory
Intellectual Property o Accounting & Book Keeping
03 07 o Loans & Funding
o Trademark
o Patent o Credit Rating Advisory
o Copyright o Audit & Assurance
o Representation & Appeal o Tax Advisory
o Financial Controls
Licence & Registration o Financial Restructuring
o Labour Licences Transaction Support
04 o RBI Licences 08 o Transaction Advisory
o Drug & Cosmetics o Due Diligence
o Ayush & Herbal o Mergers & Acquisition
o Urban Local Body Approval o IPO & FPO
o Regulatory Approvals
OUR APPROACH Our processes are aimed at solving
most complex business problems,
reducing risk and gain a competitive
advantage by achieving good
governance and financial control
ASSESSING REQUIREMENTS DEDICATED PROFESSIONAL REGULAR UPDATES
Understanding the client’s business needs and We align a professional to ensure to discuss in We thrive to keep you apprised about the status of
analyzing the requirements on call or in person as detail the compliance requirements of your your application until its completion. Every
the need be business and thorough assistance throughout the development on your application is brought to
process. your attention.
Stage 2 Stage 4
Stage 1 Stage 3 Stage 5
SIGNING OF SLA DOCUMENTS & INFORMATION
We share the estimated expenses and a service Following the SLA the necessary documents and
level agreement for the requested service information are collected from the client
Our Presence and Growth
Significant
Growth in Client 2000 +
Base Last 3 Years
2020 Happy Clients
2010 Across Industry Verticals
Clients
Around the Globe
2017
813 Clients
2013 145
850
40
100
110
50
400
350
754
75
545
200
900
400
525
171 Clients
FMCG Automobile Packaging Financial Waste Real Food &
Services Management Beverages Transport &
& Printing Estate
Leisure
Information Healthcare Consumer
Textile Metals & Energy & Banking &
Technology & Retail
Minerals Natural Insurance
Pharmaceuticals
Resources
OUR PRESENSE ACROSS INDUSTRY VERTICALS around the globe
Why Us? O U R
PROMISE
✓ We promise perfection!
✓ We promise business evolution!
✓ We ensure accuracy!
✓ We believe in business ideas!
✓ We promise OUR BEST!
Who we are
We believe in empowering businesses.
Technology Based Compliance Platform
Corpzo is an initiative by Corpzo Ventures Private Limited with a team of more than 1000 legal, finance and banking professionals, set out to
assist entrepreneurs around the globe in their business quests. We believe that every business needs nourishment in its budding stages. Ensuring
smooth navigation through the bumpy ride of legal compliance, financial risks is what we are good at.
We understand that the journey of an entrepreneur begins with his idea of a business. We, at, Corpzo, offer a complete range of professional
services and tailor-made solutions for the evolution of your business ranging from incorporation compliance, legal, financial, taxation,
technology, Intellectual Property Management, Registrations, Licensing and Marketing.
We assist you in choosing the best suited mode of business, get appropriate protection for your intellectual property, attain all the relevant
mandatory and voluntary registrations, approvals, permits and certifications. We also assist in managing the accounts, taxation, finance and
funding aspects of your business. In essence we wish for you to concentrate on your idea while we focus on the rest for you.
Our team of experts aims at easing Compliance and incubating your business growth with maximum efficiency & minimalist timeline.
ALL YOU NEED TO DO IS CALL US AND LET US WORRY ABOUT THE REST !! IT’S THAT EASY!!
www.corpzo.com
corpzo Ventures Private Limited
+91- 99991 39391
[email protected] www.corpzo.com
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