One of the most crucial things for any medical device importer to know before applying to CDSCO is the MD-15 Import License timeframe. The CDSCO import license will only be given out after checking the documentation, classifying the item, and making sure it meets all the rules, no matter whether the medical equipment you are bringing into India is low-risk or high-risk. A lot of people who apply get mixed up between the 6-month and 12-month timelines for getting permission. This in-depth tutorial goes over the differences, the processes, the delays, the paperwork needed, and how to keep your MD-15 Import License schedule on track.
Why is the MD-15 Import License Timeline Important?
The amount of time it takes to get permission directly affects:
- The date your goods will be available
- Planning for imports
- Agreements with distributors
- Shipping and inventory
- Growing a business
Companies may prevent expensive delays and plan their market launch appropriately by knowing the MD-15 Import License schedule.
What Factors Affect the MD-15 Import License Timeline?
There are a number of things that affect the CDSCO import license timeline:
1. Class A, B, C, or D for device risk
Class A and B → Usually quicker
Class C and D: A more in-depth reviews will take longer.
2. Fullness of the Application
Not having the right papers might add weeks or even months.
3. Questions from CDSCO
Every question adds time to the MD-15 Import License process.
4. Status of the Foreign Manufacturer Audit
The MD-15 import licence process may take longer if Quality Management System compliance, Device Master File (DMF), Plant Master File (PMF), or Free Sale Certificate (FSC) is incomplete or requires clarification.
5. Requirements for a Technical Review
A lot of research has to be done on the safety and performance data of high-risk gadgets.
When does the 6-Month MD-15 Import License Timeline start?
Most people who apply fall within the 6-month bracket.
This usually happens when:
- The gadget is either Class A or B
- All papers are in order
- ISO 13485 certification is strongly recommended and widely accepted by CDSCO as proof of Fifth Schedule QMS compliance. However,
- legally, manufacturers must comply with the Fifth Schedule of MDR 2017, and ISO 13485 is one recognized method to demonstrate this compliance.
- No big safety issues
- All test reports are present
- No big questions from the CDSCO
Average Timeline Breakdown
- Getting ready for the application takes 2–3 weeks.
- First look by CDSCO: 30 to 45 days
- Technical assessment takes 2 to 3 months.
Best For
- Diagnostic disposables
- It’s used in surgery
- Electronic gadgets with a low risk
- Repeated imports when earlier permissions are present
In ideal cases with Class A or B devices and complete documentation, approvals may be received within 4–6 months. However, timelines always depend on CDSCO’s technical review and query cycles.
When does the 12-month MD-15 Import License Timeline start?
Some gadgets automatically get a longer 12-month CDSCO import licence duration.
This commonly occurs when:
- The gadget is either Class C or D.
- Implants with a high risk
- No clinical evidence
- Need for further explanations
- The foreign producer does not have any QMS certifications
- The device needs a thorough technical review
A Typical Timeline Breakdown
- Getting the application ready takes 4 to 6 weeks.
- 60 to 90 days for compliance verification
- Technical evaluation by CDSCO takes 120 to 150 days.
- Questions and answers take 1–2 months.
Devices That Usually Take a Year
- Implants for the heart and bones
- Breathing machines
- Pumps for infusion
- Tools for keeping people alive
- Radiology tools
The MD-15 Import License timeframe is longer since CDSCO has to make sure the device is safe for Indian patients.
Main Differences Between a 6-Month and 12-Month MD-15 Import License Timeline
- Timeline for 6 Months
- Mostly Classes A and B
- A basic technical review
- Minimum questions
- Devices with low risk
- Documents that are complete
- A Year-Long Timeline
- Class Typical Timeline
- C 7–12 months
- D 9–14 months
- A lot of technical evaluation
- Data on device safety is needed
- More risks mean a lengthier examination.
- Many rounds of questions
Importers may better prepare the CDSCO import license procedure if they know this distinction.
How to speed up the MD-15 Import License process?
- Send in all of your papers in the right format
- CDSCO process
- First they raise a query
- CDSCO usually provides a defined time window to respond to queries. If replies are delayed, incomplete, or unsatisfactory, the application may be rejected or returned for resubmission. Multiple query rounds may occur depending on technical complexity.
- Only then does rejection happen
- Make sure the overseas producer is following the rules
- Certificates of Free Sale, ISO 13485, test reports, and so forth that are still valid.
- Answer questions from CDSCO within 24–48 hours
- Slow answers may add months. Find a regulatory partner with a lot of expertise
Regulatory experts cut down on the time it takes to get an MD-15 Import License by a lot.
Why the MD-15 Import License Timeline Is Often Late
- No Free Sale Certificate
- Wrong Device Master File (DMF)
- The testing format is wrong
- Labels that don’t follow the rules
- Missing parts from the Plant Master File (PMF)
- Not registered with the manufacturer
- Wrong categorisation of the gadget
- Late reply to queries
To keep your CDSCO import license from falling into the 12-month category, stay away from these things.
The End
The MD-15 Import License process may take anywhere from 6 to 12 months, depending on the kind of device, the quality of the paperwork, and the CDSCO’s technical evaluation needs. Those that are low-risk go quicker, while those who are high-risk are looked at more closely, which takes longer. Importers can organize their launch, shipping, and regulatory strategy more easily if they know the difference. Companies may greatly speed up the time it takes to have their CDSCO import license approved by being well-prepared, responding quickly, and keeping good records.
How long does it take to get an MD-15 Import License?
This is the overall amount of time it takes for CDSCO to approve your medical device import licence.
Why do some applications take a year?
Devices that are high-risk need a more thorough safety check and a more technical examination.
Is it possible to shorten the period for the MD-15 Import License?
Yes, by sending in all the required documentation and answering CDSCO questions immediately.
Do Class A devices usually get approved in six months?
Yes, however, it might take longer if the paperwork is lacking.
Does CDSCO turn down applications that aren’t complete?
Yes, files that aren’t complete are typically sent back without being looked at.
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