What are Forms MD-14 and MD-15? | Import License for Medical Devices in India | Swarit

Central Drugs Standard Control Organisations responsible for permitting new medicines, creating rules, monitoring the effectiveness of the drugs, and being in coordination with the state authorities in matters related to healthcare. CDSCO 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.

what do Forms MD-14 and MD-15 Signify?
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 applicants can obtain this license through an authorized Indian representative who shall file the application on their behalf.

Which authorities are responsible to license under Form MD-14
There are two authorities that are responsible for granting licenses these are the State licensing Authority and Central licensing authority.
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. It also assists with providing manufacturing licenses to devices under categories C & D.

Who can apply for import through #form #MD14 and #MD15
The importer must appoint an authorized 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
• 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
• The latest copy of the audit/ inspection report 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.
• 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
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.

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