Importing medical devices into India is not as simple as shipping and selling. To protect public health, the Indian government, through CDSCO, requires all businesses to register medical devices before importing them. If you fail to register can lead to shipment holds, legal action, or outright rejection, costing your business time, money, and credibility. That’s why it’s important to understand common mistakes businesses make in the process, so you can avoid delays and ensure smooth import operations
What is a Medical Device Import Registration?
Medical Device Import Registration is the legal process that enables a company to import medical devices from outside India for sale or distribution within the country. The CDSCO regulates this registration under India’s Medical Device Rules, 2017. Basically, if you are a business that wants to import and sell medical devices in India, you should get official permission from the CDSCO through an import registration. Check the pointers to understand why the Indian government uses this registration to:
- Ensure that only safe and approved medical devices are used in the country
- Monitor the quality and standard of devices being sold to hospitals, clinics, and patients.
- Hold importers accountable in case of faulty or harmful products.
Top 10 Mistakes To Avoid In Medical Device Import Registration
Here we have mentioned 10 mistakes to avoid in medical device import registration:
| S.No. | Common Mistake | Why It’s a Problem | How To Avoid It |
|---|---|---|---|
| 1. | Applying Without Check Device Notification | CDSCO accepts an import application only for notified medical devices. Applying for non-notified device waste time | Always confirm whether the device is listed in the CDSCO’s notified medical device list before applying |
| 2. | Incorrect Device Classification | Wrong classification (A, B, C, D) can lead to incorrect documentation and rejection | Refer to the CDSCO classification rules or seek help from a medical device regulatory consultant |
| 3. | Incomplete or Outdated Documents | Missing or incorrect documents delay processing and may cause the application to be rejected | Ensure all documents like FSC, DMF, ISO Certificates, and PoA are completely formatted |
| 4. | Choosing the Wrong CDSCO Form | Using outdated forms (eg, form 40 instead of MD 14-15) leads to an invalid application | Use form MD 14 for the registration certificate and form MD 15 for the import license. |
| 5. | Poorly Prepared Device Master File | Generic or missing technical information leads to a deficiency letter from the CDSCO | Prepare a device-specific DMF that includes all required data per CDSCO guidelines |
| 6. | Appointing an unqualified India | An agent without CDSCO authorization cannot legally represent you, risking rejection | Appoint an experienced and licensed Indian Authorized Agent or a regulatory consultancy |
| 7. | Missing Clinical Evaluation Report | High-risk devices require clinical safety data. Skipping CER causes a delay | Include CER for classes C & D devices. Use literature review or clinical studies if trials haven’t been done |
| 8. | Not Tracking Application Status on the CDSCO portal | Ignoring portal updates can result in missed deficiency letters or application closure | Regularly log into the CDSCO SUGAM portal to track application progress and reply to queries |
| 9. | Improper Power of Attorney | CDSCO needs a PoA apostille from the home country; missing this leads to rejection | Get the PoA notarized and apostilled as per CDSCO rules before submission |
| 10. | Registering Multiple Devices Under One Application | CDSCO requires separate applications for unrelated device types, and bundling devices causes rejection | Submit a separate application for each distinct device unless they belong to the same product family |
Can You Import Medical Devices Without CDSCO Registration?
No, you cannot legally import medical devices into India without CDSCO registration. If the device is listed as not a notified medical device under the Medical Device Rules, 2017.
How Do Incorrect Technical Documents Delay Medical Device Import Registration?
Incorrect technical documents can seriously delay your medical device import registration because CDSCO needs accurate and complete details to verify product safety and compliance. If any documents are missing, outdated, or don’t match the product, your application will be marked as deficient and sent back for correction.
- Mismatch in data
- Incomplete device master file
- Missing test certificates or labeling details
- Each query adds 2-4 weeks
Note: You should contact a trusted regulatory consultancy to handle all your paperwork and more, as they will prevent all kinds of mistakes to avoid in medical device import registration.
How Does Ignoring Labeling Rules Lead To Import Registration Rejection?
If you ignore CDSCO labeling rules, your medical device import registration can be rejected or delayed. That’s because labels are one of the first things regulatory officers check to confirm if your product follows India’s medical device rules.
| S.No. | Labeling Issue | How It Affects Import Registration |
|---|---|---|
| 1. | Missing Importer’s Name & Address | CDSCO needs to see the Indian Importer clearly on the label |
| 2. | No MRP or Manufacturing Date | India has specific language and layout rules for medical device packaging |
| 3. | Incorrect or Foreign Format Labels | India has specific language and layout rules for medical device packaging |
| 4. | Not imported by Declaration | This makes it unclear who is responsible in India |
| 5. | Missing CDSCO Registration Number | Mandatory after approval, missing it can create suspicion during review |
Why Choose ELT Corporate For Medical Device Import Registration in India?
Selecting the right agency for your medical device import registration in India can save your business time, money, and stress. ELT Corporate is one of the best consultancies with a proven track record in handling CDSCO licensing.
- Expertise in CDSCO Registration
- Complete End-to-End Support
- Quick & Hassle-Free Process
- Custom Compliance Solutions
- Direct Liaison With Authorization
Do I Need A Wholesale License To Import?
Yes, you require a wholesale license to import and distribute medical devices in India.
Is Clinical Data Required For Import Registration?
Yes, clinical data is required for import registration, as CDSCO can ask for clinical data to prove safety data.
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