The Procedure to apply for InVitro Diagnostic import license is followed.

• Step 1 Evaluation

Initially, evaluation of the product is to be done to ascertain whether it meets the basic norms needed to file an application for an import license as per the Medical Rule of 2017. The Competent authority should do the evaluation process.

• Step 2 Classification

If it needs Registration according to the Medical Device Rule, 2017, then classification of the In Vitro Diagnostic Device is done based on the Product Risk category.

• Step 3 Documentation

Documents required according to the New Medical Device Rule 2017 should be kept ready and should also be duly signed by the signatory authority.

• Step 4 Appointment of agent

An agent who has a license to manufacture a Medical Device and In Vitro Devices for sale and distribution is to be appointed via Power of Attorney by an Overseas Manufacturer.

• Step 5 Form Filing

An application form is generated  online.  With all its attachments the form should be duly filled. 

• Step 6 Approvals by Agent

An authorized agent is to be approved to submit the draft application form.

• Step 7 Follow up

Follow-up with the Regulatory Authority and query Management can be done in case of any doubt.

• Step 8 Grant of Approval

If all needed norms and guidelines are fulfilled, a License to Import InVitro Diagnostic Device is granted by a regulatory authority.

By using these 8 steps we can apply for InVitro Diagnostic import license.

An Overview of Apply for InVitro Diagnostic Import License

The import of InVitro Diagnostic is governed by New Medical Device Rules, 2017, in India. CDSCO (Central Drugs Standard Control Organization) has an online platform of SUGAM portal for issuing permits and submitting applications to Import InVitro Diagnostic falling by any Category A, B, C, or D respective online form is required to submit on SUGAM  is a central Licensing Authority for such products.

Eligibility to Apply for InVitro Diagnostic Device Import License

In India, for license, the international manufacturers cannot straight apply as an applicant. To submit their Application for registration in In Vitro Diagnostic Device Import License, they have to appoint an Indian Entity who is an authorised agent or license holder. The authorized agent has either a license to manufacture for sale or distribution or a wholesale license for distribution and sale for a grant of CDSCO Import License that can apply to the CDSCO. Through power of attorney, an authorised agent is any firm or organisation that an overseas manufacturer has appointed to undertake InVitro Diagnostic Devices import in India.

Forms Required for Application and Permission

• Form MD 14: Application for an import license for Class A, B, C and D IVD Diagnostic Device.
• Form MD 15: Approval Form from central licensing agency to granting permission to import IVD Diagnostic kit by grant the license. CDSCO has the  Authority to grant the license.

Important Document required to apply for InVitro Diagnostic Device Import License

According to  part II of the IV schedule of New Medical Rules 2017, the applicant is required to submit the following Documents for import registration.

Covering letter-

• The applicant has to specify whether the Application is for Registration or re-registration
• A list of Documents should also be included in the letter.
• An authorized signatory should duly sign all the Documents
• Details of Products to be imported
• Detail of manufacturing site
• Regulatory and other required Documents for attachment as per Form MD 14
• Power of Attorney
• ISO13485 Certificate
• TR 6 Challan
• GMP Certificate
• CE Design Certificate
• Declaration of Conformity
• PMS Report
• Business License/Plant Registration Certificate
• Audit Report
• Constitution Details of the Indian Agent
• For Registration of import of Invitro Diagnostic Kit valid wholesale or manufacture license of the agent authorized in India.
• Quality certificate by overseas Manufacturers providing assurance of product’s quality.
• A free sale Certificate (FSC) is needed to be submitted along with the Application. FSC provides assurance that the intended InVitro Devices to be imported are sold freely in the export country, and there is the approval of it for trade liberalization and export. 

Plan master files must include the following details

• Detail of manufacturing procedure of In Vitro Diagnostic Medical Device
• Detail of source of antigen/antibody
• Characterization of antigen/antibody
• Detailed Composition of the InVitro Diagnostic Device
• Medical Flowchart Process of InVitro Diagnostic Device
• Batch release Certificate
• Detailed Test Report

Validity of License

The import license granted in form MD 15 remains Valid  provided the license retention fees are paid as specified in the second schedule prior to the expiry of 5 years from the date of its issue . This is done only when the License is not Suspended canceled or Suspended by CDSCO (the Central Drugs Standard Control Organization).

Key points

For a Medical Device Import license, some important points must be kept in mind before applying.

• One should ensure the availability of “Free Sale Certificate” from GHTF countries.
• Check the number of Manufacturing sites which are involved in the Application
• The Power of Attorney format must be in asimilar manner as specified in the guidelines for Regulation of Medical Device rules, 2017.
• The Documents needed for Device Master File and Site Master File or any Technical Documents should also be based on the Medical Device Rules of 2017.
• Apostillation and Notary should also be based on the Guidelines of Medical Device Rules of 2017.
• If an Authorized agent has a license to manufacture for sale and distribution or has a License of wholesale sale and distribution then an agent in India is considered an Authorized agent for Grant of License for InVitro Diagnostic Device.