Process To Get A Medical Device Import License for Testing, Clinical Evaluation or Investigation in India

Comments · 81 Views

Process To Get A Medical Device Import License for Testing, Clinical Evaluation or Investigation in India. Hire a Medical Device Import License Consultant to get support for Medical Device Import Test License in India.

STEP-BY-STEP PROCESS TO GET AN IMPORT TEST LICENSE IN INDIA

  • In India, a test license is required to import medical devices.
  • The medical device is divided into four categories A, B, C, and D; thus, for all the classes test license is required.
  • The test license gives a heads up to the government of India to keep an eye on the ongoing testing of medical devices.
  • Testing medical devices is a method to determine if a medical device is fit for use, side effects, corrective actions, and areas of improvement.

 

  • Medical devices are tested to prove that they are safe for both the user and the operator.
  • Medical device testing should occur in NABL accredited labs. Applicant shall submit the report issued by the central medical devices testing laboratory or a medical device testing laboratory registered under rule 83 or by any laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories or by any hospital accredited by National Accreditation Board for Hospitals and Healthcare Providers or by any Central Government or State Government Laboratory of any hospital or of any institute, specified by the concerned State Licensing Authority or the Central Licensing Authority 
  • In medical device rule,2017 Chapter V with title import of medical device has sub-rule (40) which states that:
  • Applicants can import any medical device for clinical investigation, testing, assessment, demo, or training.
  • The CLA (central licensing authority) handles the import of medical devices for any purpose.
  • Anyone who wants to import a medical device for any investigation can apply through Form MD-16.
  • Form MD 16: The application to import medical devices for testing, evaluation, demonstration, or training.
  • Form 17: It is the permission to import medical devices for testing, evaluation, demonstration, or training.
  • If the CLA gets a satisfactory response from the applicant during the inquiry, then permission to import medical devices is granted.

 

Application form

Approval form

Class

fees

Licensing authority

Form MD-16

Form MD-17

USD 100

CDSCO

 

 

  • Steps to get the Test License(Import) in India:

  • Step 1 – Chapter V, rule 34 states that:
  • Medical devices imported shall be used exclusively for clinical testing, evaluation, demo, and training and not for any other purpose.
  • The applicant shall mention where testing will be done in the test license.
  • The applicant shall give prior information to CLA if the medical device needs to be taken to any other place for testing.
  • The license holder needs to document the activities, manufacturer name, import quantity, and date.
  • The invoice shall be present along with the medical device's quantity and name.
  • Unused Medical devices can be exported back or destroyed as per CLA orders.

 

  • Step 2 – Fill out the Form:
  • Fill the Form MD -16 at cdscomdonline.gov.in.

Note: If the person who wants to get a test license is not from India, then they need the help of the authorized agent.

  • The authorized agent must have a valid wholesale or sale or manufacturing license.

 

  • Step 3Pay the fees
  • Fees Rs. 100 USD under the head of the account through the government treasury challan.

 

  • Step 4 -Collect the documents:Technical documents to import test licenses for medical devices.
  • Cover letter
  • A brief description of the medical device, intended purpose, construction material, and design shall be present.
  • Quantity justification imported
  • Protocol of test, clinical investigation (if any)
  • Quality certificate, QMS of the manufacturer
  • Labels, IFU
  • An undertaking declaring the medical device planned to import will be used solely for testing purposes mentioned in serial 7 of MD-16 and will not be used commercially.
  • The applicant will provide a declaration from the testing laboratory declaring the types of equipment, instruments, and human force to test the medical device.
  • Fees
  • Legal form

 

  • Step 5 – Decision of CLA

 

  • If CLA is satisfied with the report, then a test license to import medical devices for testing is granted in Form MD – 17.
  • If CLA is unsatisfied with the report, it rejects the application. 

 

  • License validity – 

 

  • The validity of Form MD – 17 is for three years.
  • If, in any case, the license gets suspended or cancelled, then the applicant can apply within 45 days from the action date. 

Summary – 

  • To compensate for the increasing demand for medical devices in India, the government is launching new policies to import medical devices smoothly and quickly.
  • India's government is continuously strengthening the infrastructure required to test medical devices and prepare detailed SOPs.
  • The government plans to make medical device testing mandatory in the coming years.
Comments