CDSCO Labeling Checklist for Imported Devices

The CDSCO labeling checklist for imported devices is a mandatory regulatory requirement that guarantees that all imported medical devices entering India follow the safety, quality, and transparency standards as fixed by the CDSCO. This checklist plays a vital role in protecting public health by making sure that the medical device labels carry all necessary information needed for their complete use, traceability, and regulatory compliance even if you’re importer, distributor, or foreign manufacturer supplying to India, following these labeling guidelines is important to avoid clearance delays, penalties, or product rejections at customs. Let’s get into the CDSCO Labeling Checklist for Imported Devices to understand this from the core, including what needs to be displayed, who should apply, and how you can stay compliant. 

What Is The CDSCO Labeling Checklist For Imported Devices?

The CDSCO Labeling Checklist for Imported Devices is a set of mandatory requirements that define what information must be present on the label of all medical devices imported into India. These guidelines are framed under the Medical Device Rules, 2017, and are appropriate to all classes of devices. This checklist ensures that:

1. The instrument is traceable to its manufacturer or importer. 
2. Accurate and clear information is available to end users and authorities.
3. Imported devices meet Indian regulatory norms before reaching the market.

Why Is The CDSCO Labeling Checklist Important For Imported Medical Devices?

The CDSCO labeling checklist for imported medical devices is necessary because it makes sure:

1. Patient Safety – Correct labels help medical professionals and users perceive product usage, expiry, and risk factors.
2. Regulatory Compliance – Labels should follow Indian laws to avoid rejection or customs delays. 
3. Transparency – Details such as labels, country of origin, MRP, and manufacturing information have to be disclosed. 
4. Custom Clearance – Non-compliant labelling can result in seizure of goods at ports. 
5. Avoid Legal Issues – CDSCO can impose penalties or take legal action in case of misleading or improper declarations. 

Who Needs To Follow The CDSCO Labeling Checklist For Imported Devices?

Certainly, the CDSCO labeling checklist for imported medical devices should be followed by:

• Authorized importers registered with the CDSCO.
• Foreign manufacturers are selling through Indian distributors.
• Indian agents holding Form 41 or Form MD 15 licenses.
• Online sellers and e-commerce platforms dealing with imported devices.

Even warehouses storing imported instruments should confirm that products are labeled according to CDSCO norms before distribution. 

What Are The Mandatory Labeling Requirements Under CDSCO For Imported Devices?

The important labeling requirements under CDSCO are provided in Rule 44 of the Medical Device Rules, 2017. Here we have mentioned a list of some important declarations:

S.No.	Mandatory Information	Description
1.	Name of Device	Generic name, not only brand name
2.	Model Number	Applicable for electronic/variant devices
3.	Manufacturer’s Name & Address	Must be as per the registered license
4.	Country of Origin	Indian importer’s registered address
5.	Manufacturing Date	Mandatory post-2020 regulation
6.	Expiry Date (If Applicable)	Month and year of manufacture
7.	Batch or Lot Number	For consumables or sterile devices
8.	Net Quantity	Ensures traceability
9.	Storage Conditions	Especially for Items like bandages or packs
10.	Instruction For Use	Temperatures, humidity, etc
11.	MRP (Inclusive for Use)	If not printed, must be included in a leaflet
12.	CDSCO Import License Number	As per Legal Metrology (Packaged Commodities) Rules

What Information Should Be Displayed On Labels Of Imported Medical Devices?

Apart from the essential declarations mentioned above, CDSCO requires that the labeling should be:

• Legible and permanent
• In English or bilingual
• Positioned clearly so the text is not hidden under seals or folds
• Resistant to damage during shipping or handling

Note – All outer packaging should carry full information if the label is on a small unit. 

CDSCO Label Format Guidelines For Imported Devices

You should know that the CDSCO label format guidelines for imported devices don’t prescribe a fixed template, however, you should follow the points we have mentioned below:

• Information should be printed, not handwritten
• Use standard symbols for sterilization, expiry, etc. 
• Font size should be readable (minimum 1.5 mm recommended).
• MRP should be in bold and labeled as “inclusive of all taxes”.
• The CDSCO license number should be mentioned. 

If a label is modified in India, for example, to include MRP, it is required to be done using non-removal stickers before clearance at the port. 

Common Mistakes To Avoid In CDSCO Labeling of Imported Devices

Usually, many importers unintentionally violate labeling norms. Here are some basic errors you should avoid:

1. Using only the brand name and not the generic device name
2. Skipping the import license number (Form MD 15)
3. Labeling only the shipper carton, not the inner product pack
4. Incorrect or no declaration of MRP
5. Leaving out the name and address of the importer
6. Using removable stickers for key information

Why Choose ELT Corporate for CDSCO Labeling Compliance For Imported Devices?

At ELT Corporate, we give the end to end regulatory support to make sure your imported medical devices meet CDSCO labeling requirements without error:

• Expertise in medical device compliance 
• Hands-on experience with imports and the CDSCO SUGAM Portal
• Documentation and label review services
• Custom solutions for different classes of devices
• Affordable & time-efficient processes