Import License for Medical Devices from CDSCO

In India, if a medical device is to be imported, the importer must obtain an import license from the Central Drugs Standard Organisation (CDSCO) which is the regulatory body that is responsible for the registration and regulation of medical devices in India.

Steps for Applying for an Import License from CDSCO

• Step 1- Classification of the Medical device as per their risk class (Class A, B, C, D)
• Step 2- Registration on the Sugam Portal of CDSCO
• Step 3- Uploading all the necessary documents in the Sugam Portal
• Step 4- Submission of the Government Fee
• Step 5- Submission of the Application
• Step 6- Queries could be raised by CDSCO on the Submitted Application
• Step 7- Replying to the Queries raised by the Central Drugs Standard Organisation (CDSCO)
• Step 8- Approval or Rejection of the Application
• Step 9- Grant of License

Documents Required for an Import License

• Quality Certification (CE Certification, USFDA, Health Canada etc)

For any medical device which is imported in India it must have any one of the globally accepted quality certifications to ensure that the imported devices don’t possess a threat to the safety and health of the population.

• Declaration of Conformity in the prescribed formats.
• Power of Attorney
• Device Master File
• Plant Master File
• Free Sales Certificate
• Legal Form
• Cover Letter

Who can apply for an Import License

For importing a medical device in India the foreign manufacturer has to appoint a local authorized agent who must possess a license for either manufacturing medical devices for distribution and sales (Form 20B) or wholesale distribution of medical devices (Form 21B). The applicant will then submit an application on the Sugam portal of CDSCO.

How will Maven assist you in Obtaining the Import License

We at Maven, understand the complexities of medical device regulations. Let us handle the application process of Import License and you can focus on your core business areas. Our team of experts ensure meticulous attention to detail which results in error-free applications, avoiding rejections and delays for obtaining the license.

Our scope includes:

• Explain & share the documentation requirement for an import license.
• Review the submitted documents of foreign manufacturers.
• Preparation of administrative and other documents required to be submitted to CDSCO.
• Application and uploading the documents to the Central Drugs Standard Organisation (CDSCO) portal for Import License.
• Reply to the comments if any are received from the authority.
• You will get your license after the successful closure of comments.

Government Fee to be Paid to CDSCO

The government fee to be paid is determined by the Class of Medical device based on the risk category. The fee to be paid are: