What is Forms MD-14 and MD-15

FORM MD-14 and MD-15
Ganesh Nair
| Updated: Sep 07, 2022 | Category: CDSCO

Central Drugs Standard Control Organisation (CDSCO) is the authority that works under the Directorate General of Health Services. CDSCO is responsible for permitting new medicines, creating rules/ regulations, monitoring the effectiveness of the drugs and being in coordination with the state authorities in matters related to healthcare. Another essential function of CDSCO is that it also grants certification for the import and export of medical equipment; for this, the manufacturer/ importer needs to acquire Form MD-14 and MD-15. This article shall throw light on what is Forms MD-14 and MD-15.

Form MD-14 and MD-15: Meaning

If any person wishes to import devices that fall under the category of ‘notified medical device’. Then he must possess Form MD-15 from CDSCO. If the applicant doesn’t have the import license, then he needs to file an application to the CDSCO via Form MD-14. The applicant can obtain this license through an authorised Indian representative who shall file the application on his behalf.

  • MD-14: the applicant fills in this form, along with requisite fees and documents, to obtain an import license.
  • MD-15: The applicant obtains the import license in Form- MD-15 for the import of medical devices from Class A-D

Which authorities are involved in granting licenses under Form MD-14 and MD-15

The applicant has to get permission from two authorities/bodies for the grant import license under Form MD-14 and MD-15; these are:

  • State licensing Authority (SLA)- The state license authority is responsible for giving out loans, manufacturing licenses and wholesale licenses to medical devices that fall under Class A and B.
  • Central Licensing Authority (CLA): The Central licensing authority is responsible for providing licenses for the import of medical devices in the country. CLA also assists with providing manufacturing loans to devices under categories C & D.

The fee to be paid in Form MD-14

The applicant will be required to pay the following fees to get the License MD-15

License fee for Form MD-14 (other than In vitro)

S.no

Purpose

For Site

For Device

1.

Import license Class A

$1000

$500

2.

Import license Class B

$2000

$500

3.

Import license Class C /Class D

$3000

$1500

License fee for Form MD-14 (For In vitro)

S.no

Purpose

For Site

For Device

1.

Import license Class A

$1000

$10

2.

Import license Class B

$1000

$10

3.

Import license Class C /Class D

$3000

$500

Who can apply for import through Form MD-14 and MD-15?

The importer must appoint an authorised Indian agent. The agent must possess a manufacturing or wholesale license in FORM 20B and 21 Bas per the CDSCO guidelines. The agent shall then apply for the license through Sugam online portal.

Documents required to obtain a license in MD-15

There is a comprehensive list of documents required to obtain a license in MD-15

  • A Covering letter
  • A self-attested copy of the agent’s wholesale/ manufacturing license
  • A notarized copy of the Free sale certificate of the product as granted by the National regulatory authority of the country of origin
  • The latest copy of the audit/ inspection report carried out by competent authority within the past three years. (if applicable)
  • Certified copy of the ISO: 13485
  • Certified copy of the CE quality assurance
  • Certified copy of the CE design certificate
  • Plant master file
  • Device master file
  • Flow chart of device design
  • Flow chart of the manufacturing process
  • Notarised copy of the manufacturing site overseas
  • Power of attorney
  • Copy of FEE challan

The process to obtain an import license as Form MD-15

  • The applicant must evaluate the product as per the Medical device Rules 2017[1].
  • Then the applicant must log on to the Sugam portal of CDSCO with the registered ID and password.
  • Appoint the authorised agent
  • The applicant needs to fill in the required details on the portal
  • Upload relevant documents as mentioned in the list above
  • Recheck /Confirm the data in the draft application and submit it
  • Reply to any query raised by the regulatory authorities
  • Medical device Import approval via Form MD-14 shall be received.

Validity of the License obtained under Forms MD-14 and MD-15

The validity of the license issued in Form MD-15 is perpetual. The applicant does not have to renew the license as long as the retention fee is being paid as per the norms stated in the second schedule. The retention fee must be paid in a timely manner in a span of five years from the date of issue unless the Central Licensing authority revokes it.

Conclusion

Forms MD-14 and MD-15 are essential to acquire permit import of medical devices in India. CDSCO has streamlined this possible by making the stakeholders obtain this permission easily by applying through the Sugam portal. This license shall be valid to the applicant for perpetuity as long as he pays the retention fee.

Read our Article:Registration of Software as Medical Device in India

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Ganesh Nair

Ganesh Nair completed his graduation in law from IP university. He is an ardent researcher who has written various research papers and articles on contemporary legal issues. His keen interest in the field of research made him pursue a career in legal research. His core area of interest include Cyber, IPR and Finance laws.

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