For multinational firms, it might be hard to understand how to apply for an import licence from India’s regulatory body, CDSCO. That’s why it’s very necessary to know the MD-15 checklist CDSCO. India has rigorous rules on bringing in medical equipment, and all foreign manufacturers must meet the rules set out in the Medical Device Rules, 2017. If any of the documents are missing, confusing, or wrong, CDSCO might ask questions or even turn down the application. This in-depth tutorial goes over the whole MD-15 application paperwork checklist from CDSCO and assists producers from other countries in having everything ready right before applying.
What is an MD-15 licence to import?
The MD-15 import licence issued by CDSCO is the formal permission from CDSCO that lets an importer in India introduce medical equipment from a foreign factory into the Indian market. International producers must provide their Indian authorised representative all the documentation on the MD-15 application documents checklist CDSCO.
Why international companies need to follow the MD-15 application rules
Before giving an MD-15 import licence, CDSCO looks at three things:
- Safety of the device
- Compliance at the manufacturing site
- The foreign manufacturer’s authenticity
The MD-15 application paperwork checklist CDSCO has a lot of technical and legal documentation for this reason. They assist CDSCO in making sure that only safe and authorised medical equipment comes into India.
Application Documents Required for MD-15 Import License (For All Foreign Manufacturers)
Here is the full set of MD-15 application documentation that every multinational company must have ready:
1. Power of Attorney (POA)
- Must explicitly name the Indian importer as the agency in charge
- POA must be notarised and either apostilled OR attested by the Indian Embassy.
2. Certificate of Free Sale (FSC) or Certificate to a Foreign Government
- Given out by the country’s governing body
- Must check if the equipment is legal to sell and use in that nation
3. Certificate of ISO 13485
- The manufacturer must provide a genuine Quality Management System certificate
- Must be the same as the address of the factory
4. CE Certificate or equivalent foreign approval (if available)
- Shows that you follow international safety rules
- Helps make the MD-15 application stronger
5. Site Master File (SMF / PMF)
- Gives a complete picture of the production facilities
- Includes the layout, equipment, quality system, and process controls.
6. The Device Master File (DMF)
- Includes technical information, including the design of the device, the materials used, the sterilisation process, the risk analysis, and the shelf life.
7. Labels for Products (Artwork)
- Must follow Indian standards for labelling
- Must include information such as the name of the device, the name of the importer, warnings, shelf life, and so on.
8. Insert for the pack / IFU (How to Use)
- Must have directions for use, cautions, and things to avoid
9. Clinical Evidence / Clinical Evaluation Data
- Necessary for certain medical equipment
- Can contain published research, statistics on performance, and safety analysis
10. Undertaking of No Material Change (No Change Declaration)
- The manufacturer must make sure that the gadget being registered is the same as the one that is being sold.
11. Audit Reports, if they apply
- Reports from the US FDA, EU Notified Body, MHRA, and others on GMP inspections
- Audit reports (US FDA, EU NB, MHRA, etc.) may be requested for higher-risk Class C/D devices, but are not mandatory for all cases
12. Declaration of Conformity (DoC)
- The manufacturer says they follow all relevant international standards.
13. A list of all the places where things are made and put together
- CDSCO checks to see whether the addresses on the site match the documentation.
14. Data on stability (for devices that have been sterilised)
- Must check for sterility and performance during shelf life
15. Business License for a Manufacturer in Another Country
- The company’s legal registration paperwork
- This is the full collection of MD-15 application paperwork that every foreign producer must have ready before they send them in.
Additional Documents Indian importer (agent) needs
The Indian importer must send in the following while the overseas producer gets the aforesaid documentation ready:
- Licence for the importer to make or sell goods
- Information about the site
- Information about device categories
- Forms for applying via the SUGAM portal
- Receipts for paying fees
This coordination makes sure that the MD-15 application paperwork checklist CDSCO are sent in without any problems.
Why it’s important to make the MD-15 Application Documents Checklist CDSCO ahead of time?
Getting everything ready before you submit helps you avoid:
- Questions from CDSCO
- Approval delays
- Refusal because the information didn’t fit
- Requests for further documents
International manufacturers may gain clearance much quicker if they meticulously follow the MD-15 application papers checklist from CDSCO.
Mistakes That Often Get You Rejected
Small errors might create big issues while processing MD-15.
The most prevalent problems are:
- Certificates with the wrong address for the manufacturer
- The government did not issue the FSC.
- Errors in labelling or artwork
- POA not signed
- Parts of DMF or SMF are missing
- Using certifications that are outdated or have expired
- Clinical data that isn’t comprehensive
If you don’t make these mistakes, the CDSCO evaluation will go more smoothly.
How ELT Corporate Helps Businesses Around the World
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A skilled regulatory consultation can assist with:
- Making the whole list of papers needed for the MD-15 application for CDSCO
- Writing POA and statements
- Checking the DMF, SMF, artwork, and FSC
- Making sure that Indian labelling requirements are followed
- Putting in an application on the SUGAM portal
- Answering questions from CDSCO
- This lowers the risk and speeds up the approval process.
Conclusion
The MD-15 application papers list for overseas companies who want to bring medical products into India, the CDSCO is the most critical stage. Proper paperwork makes it easier to get clearance, go to market quicker, and follow all the rules. International producers may fulfil CDSCO’s requirements and finish the MD-15 import licence procedure without delays by getting all the paperwork ready ahead of time and working closely with the Indian importer.
Do all medical equipment that is brought into the country need an MD-15 licence?
All foreign-manufactured medical devices require MD-15 except certain Class A non-sterile, non-measuring devices, which follow a simplified online registration route instead of full MD-15.
Does the company need to have an office in India?
No, however, they need to hire an official Indian agent via a POA.
How long does it take to receive an MD-15?
It usually takes 3 to 6 months, depending on how good the documents are and how busy the CDSCO is.
Do all devices need clinical data?
Only for certain devices; CDSCO makes the decision depending on the danger of the gadget.
Is it possible for one importer to utilise papers that were given to another importer?
No, the POA and paperwork must mention the approved agent by name
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