Overview of InVitro Diagnostic Device Import License
New Medical Device Rules, 2017, govern the import of InVitro Diagnostic. Central Drugs Standard Control Organization has made an online platform, SUGAM, for submitting applications and granting permission Of Import of IVD falling under any Category A, B, C, or D respective online form is required to be submitted on SUGAM, which is a central Licensing Authority for such products.
Who can apply for InVitro Diagnostic Device Import License?
The foreign Manufacturers can not directly apply as an applicant in India for Registration. They must appoint an Indian Entity who is an authorized agent or license holder to submit their Application for Registration of Imported InVitro Diagnostic Device. The authorized agent having either License to manufacture for sale or distribution or a wholesale License for sale & distribution can apply to the CDSCO for a grant of Import License. An authorized agent is any firm or organization that has been appointed by an overseas manufacturer through ‘Power of Attorney ‘to undertake Imports of InVitro Diagnostic Devices in India.
Forms Required for Application and Permission
Application Form to get import license for IVD Diagnostic Device
Approval Form from central Licensing Agency to grant permission to import IVD Diagnostic kit
Authority to Grant license
A, B, C,&D
What is a process to apply for License of Import of InVitro Diagnostic Device?
Step 1 Evaluation
Firstly evaluation of product is to be done to ascertain whether it fulfills the basic norms required to file application for import license as per Medical Rule of 2017. The process of evaluation must be done by competent authority.
Step 2 Classification
If it requires Registration as per Medical Device Rule, 2017, then classification of the In Vitro Diagnostic Device is done as per the Product Risk category.
Step 3 Documentation
Documents required as per the New Medical Devise Rule 2017 must be kept ready and must also be duly signed by signatory authority.
Step 4 Appointment of agent
Then agent who has a license to manufacture a Medical Device and In Vitro Devices for sale and distribution is to be appointed through Power of Attorney by an Overseas Manufacturer.
Step 5 Form Filing
An application form is generated online. The form must be duly filled with all its attachment.
Step 6 Approvals by Agent
The draft application form is to be approved and submitted by an authorized agent.
Step 7 Follow up
In case of any doubt, Follow up with Regulatory Authority and query Management can be done.
Step 8 Grant of Approval
If all required norms and guidelines are fulfilled, a License to Import InVitro Diagnostic Device is granted.
Important document For License of Import of InVitro Diagnostic Device
As per part II of the IV schedule of New Medical Rules 2017, the applicant is required to submit various documents for import registration.
- Covering letter –
- The applicant has to mention whether the Application is for Registration or re-registration.
- The letter should also include a list of documents.
- All the documents must be duly signed by an authorized signatory.
- Details of Products to be imported
- Detail of manufacturing site
- Regulatory and other 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
- Valid wholesale or manufacture license of the agent authorized in India for Registration of Import of InVitro Diagnostic Kit.
- Quality certificate by overseas Manufacturer giving assurance of product's quality.
- A free sale Certificate (FSC) is required to be submitted along with the Application. FSC is a document which gives assurance that intended InVitro Device to be imported are sold freely in the export country, and there is the approval of it for export and trade liberalization
- Plan master files including the following details
- Detail of manufacturing procedure of In Vitro Diagnostic Device
- Detail of source of antigen /antibody
- Characterization of antigen /antibody
- Detailed composition of the InVitro Diagnostic Device
- Medical Flow chart process of InVitro Diagnostic Device
- Batch release Certificate
- Detailed Test Report
Validity of License
The import license granted in form MD 15 remains Valid forever provided the license retention fees are paid as mentioned in the second schedule before the expiry of 5 years from the date of its issue ends. This is done only if the License is not Suspended or cancelled by the Central Drugs Standard Control Organization.
Some important points must be kept in mind before applying for a Medical Device Import license.
- One must check the availability of "Free Sale Certificate: from GHTF countries.
- Check the number of Manufacturing sites Involved in the Application
- The Power of Attorney format must be in the same manner as mentioned in the guidelines for Regulation of Medical Device rules of 2017.
- The documents required for Device Master File and Site Master File or any Technical Documents must also be as per the Medical Device Rules 2017.
- Apostillation and Notary must also be as per the Guideline of Medical Device Rules, 2017.
- An agent in India is considered an Authorized agent for Grant of License for InVitro Diagnostic Device only if they have a license to manufacture for sale and distribution or have a License of wholesale sale and distribution.
CorpBiz support for Import License for InVitro Diagnostic Device
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Frequently Asked Questions
Yes, as per the sixth schedule, the changes can be made manufacturing process, equipment and Testing, Primary Packaging Material, and labels. Permission from a competent authority is required for doing changes.
Only if Central Licensing Authority finds it necessary to inspect an overseas manufacturing site it may carry out an inspection.
A new agent is required to submit all important documents like new power of attorney, MD 14 Form, manufacturing & wholesale License, government fees, label, and copy of import license issued to the former importer. Apart from this, an undertaking is to be submitted by the Manufacturer that there is no change in the device master plan, site master plan and all other regulatory and technical documents submitted to CDSCO by the previous agent.
No, it is not mandatory.
The devices having a valid import license can be imported from any authorized port in India and can be stocked and distributed from any registered warehouse.
The Medical Device already marketed in India shall continue to be marketed before the expiry of 18 months or the current validity of the License from the beginning of Medical Device Rules 2017. Such devices are known as Predicate Devices
Apart from the Import license, Free Sale Certificate is also required, which is generally issued by a competent authority in any of the countries (Australia, Canada, and Japan, the countries of the European Union or the United States of America).