Import License For In-Vitro Diagnostic Kits in India - Form MD14 & MD15
Get Your Import License for In-Vitro Diagnostic Kits (IVD) and Medical Devices with CliniExperts. Hassle-free assistance in providing Import License of Form MD 15.
Permission To Import In-Vitro Diagnostic Kits (Form MD 14, 15) – Overview
- The license to manufacture for sale or distribution
- Wholesale license for sale or distribution
Who Can Apply?
An authorized agent having either of the below-listed licenses can apply to the CDSCO for the grant of import license:
- The license to manufacture for sale or distribution
- A wholesale license for sale or distribution
How To Apply?
The Applicant must follow the following process:
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Evaluation of the product, whether it requires registrations MDR 2017 (Regulated/Non-Regulated) or not
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If requires registration, evaluation of classification (Class A, B, C, D) based on the product risk category
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Document preparation as per the MD 14 checklist
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Appointment of an authorized agent
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Online generation of application
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Approval/confirmation of draft application by the authorized agent
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Follow-up with regulatory authority and query management if any
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Final approval
Validity
The Import License for IVD in form MD-15 can remain valid forever. This is possible if the fee for IVD License Retention as specified in the Second Schedule is paid before the 5 years from the date of its issue ends. Also, the license should not be suspended or cancelled by the CDSCO.
Fee Involved
In-Vitro Diagnostic Kits (medical devices) are categorized to ensure safety and effectiveness. Here is the fee structure for granting an import license:- One site $1000: In-vitro diagnostic kits Import license fee for Class A or Class B IVD medical devices. For each distinct in-vitro diagnostic kit license cost is - $10
- One site $3000: In-vitro diagnostic kits Import license fee for Class C or Class D IVD medical devices. For each distinct in-vitro diagnostic kit license cost is - $500
Important Documents
- Wholesale License
- Power of Attorney
- Free Sale Certificate from GHTF
- Device Master File
- Site Master File
Timeline to get
MD15
from Central Drugs Standard Control Organisation
6 to 9
MONTHSEssential Tips
Some Key points, you must pay attention before applying for the medical devices import license.
- Check availability of "Free Sale Certificate" from the GHTF Countries.
- Check the number of manufacturing sites involved in the application.
- Power of Attorney must be submitted in same format as shown in MDR 2017 (Guidelines for Regulation of Medical Devices, 2017).
- Any technical documents including Device Master and Site Master Files need to be prepared as per the format given in MDR 2017.
- Prior permission by CDSCO by filling “Form MD-29” will be required for applications that do not have a “predicate device”. No licenses will be granted to import such devices without this permission.
- All notary and apostillation of the documents should be done according to the guidelines in MDR 2017.
- An authorized agent must be appointed. An authorized agent is the one who has any one of the following licenses.
- License to manufacture for sale or distribution
- Wholesale License for sale or distribution
Expert Advise
CliniExperts strives to streamline the process of licensing to import IVD kits in India as per the Medical Devices Rule 2017.
The Power of Attorney (POA) is the base of the application process for obtaining “Import License for IVDs”. Therefore, it should be prepared very meticulously.
The product name and model numbers must be in line with POA, FSC, Label and Instructions for use (IFU) and other technical documents.
The products should be grouped correctly according to the Grouping Guidelines on Medical device issued by the MoHFW Govt. If it is not done, it may incur additional Government fees.
Frequently Asked Questions
What are the major changes in Post approval of IVD?
The major changes post approval of IVD as per the Sixth Schedule are any changes in:
- Labels
- Manufacturing process
- Equipment or testing
- Primary packaging material . These changes need prior approval from the competent authority.
What are the documents required in case of multiple importers?
A new agent has to submit all necessary legal documents like MD 14, the new Power of Attorney, government fees, wholesale or manufacturing licenses, label, IFU, and a copy of the import license issued to the former agent. Additionally, an undertaking from the manufacturer must be submitted stating there is no change in the device master file, plant master file, and other regulatory documents submitted to CDSCO by the previous agent along with their name, address & import license number for registration. When in doubt, take the help of a consultant to make sure your documentation is in place.
Will overseas manufacturing site of IVD be inspected before grant of import Licence?
No. However, if the Central Licensing Authority finds it necessary, it may carry out an inspection of the overseas manufacturing site before the grant of import licence.
Is it mandatory for the IVD medical devices that are imported to India to be stocked at the warehouse address that is listed on the medical device import licence initially?
No. It is not mandatory to initially stock them in the warehouse address that is listed in the import Licence. IVD medical devices having a valid Import Licence, can be imported from any notified ports of India. They can be stored and distributed from any registered warehouse.
Can IVD medical devices imported under valid import Licence be stocked in any wholesale Licence premises other than the one stated in the Import Licence?
Yes, IVD medical devices imported under a valid Import License can be stocked in any wholesale Licence premises other than stated in the Import Licence.
How many batches of medical devices have to be evaluated for the submission of Performance evaluation reports for grant of Import Licence for IVDs of Class B, Class C and Class D?
The applicant has to submit performance evaluation reports (PER) for three independent batches of IVDs, manufactured using three different lots of “key” raw materials (e.g. Antigen, antibody) for the grant of the Import license.