On this page
- Medical Device Import License
- Registration Is Mandatory for Medical Devices
- Eligibility Criteria
- Foreign Medical Devices Imported
- Risk Classification of Medical Devices in India
- Form MD-14 and Form MD-15 Explained
- Documents Required for Medical Device Import License
- Getting License Through the SUGAM Portal
- Medical Device Import License Cost
- Validity of the Import License
- Common Mistakes to Avoid
- Conclusion
License to Import Indian Medical Devices is required for all businesses importing medical devices which are manufactured in foreign countries. CDSCO import license is an essential procedure that companies should undertake in order to market and distribute medical devices in India.
This guideline can be helpful for importers, distributors, and foreign producers who wish to import medical devices into India. The guideline explains all the essential aspects of the import licensing process in India.
Medical Device Import License
In India, medical devices are imported under the Medical Devices Rules, 2017, which are governed by the CDSCO. Depending on the kind of the medical device, the importer may have to get the necessary import license prior to importing the device into India.
Lack of an import license can result in the detention of consignment at the border. You can read more about how central approvals work on Certilize’s CDSCO Permission page.
Registration Is Mandatory for Medical Devices
Yes, CDSCO registration is mandatory.Earlier, licensing was necessary only for certain categories of devices, presently, all kinds of devices, from low-risk to high-risk, are included in the licensing process. Therefore, be it a simple thermometer or a highly advanced implant, you will need to have a license.
Eligibility Criteria
It may be done either by the foreign manufacturer himself or by his authorized agent in India. Most of the time, an authorized agent in India applies for the foreign manufacturer. An authorized agent in India should have a valid wholesale license and an authorization letter from the manufacturer.
Foreign Medical Devices Imported
Foreign medical devices can definitely be imported into India, but only after the importer or manufacturer gets the import license from CDSCO. The device should also meet quality standards and follow Indian labelling rules.
Risk Classification of Medical Devices in India
The CDSCO classification of medical devices has been made on the basis of risk involved with them, and they can be classified as follows:
- Class A – Low risk – bandages, thermometers and tongue depressors
- Class B – Low to medium risk – syringes, blood pressure gauges and suction devices
- Class C – Medium to high risk – ventilators, bone fixation plates and infusion systems
- Class D – High risk – heart valves, pacemakers and implants
The class of your device determines the documentation required, the fee and the extent of review involved. Incorrect classification is a typical error that applicants make while registering their devices with the CDSCO, and you should refer to the CDSCO classification list before applying. Same goes for registration of Class A medical devices too.
Form MD-14 and Form MD-15 Explained
These two forms are the heart of the import process.
Form MD-14- is the application form you submit to CDSCO to request an import license.
Form MD-15- is the actual import license issued by CDSCO after your application is reviewed and approved.
In simple words, MD-14 is what you apply with, and MD-15 is what you receive.
Documents Required for Medical Device Import License
It is better to have all the documents ready before the start of the process, since lack of document can cause delay.The usual documents include:
- Duly filled Form MD-14
- Power of attorney or authorisation letter from the manufacturer
- Free sale certificate from the country of origin
- ISO 13485 certificate of the manufacturing site
- Device Master File and Plant Master File
- Product details, specifications and intended use
- Labels and instructions for use (IFU)
- Proof of approval from other regulatory bodies, such as CE or USFDA, where available
- Test reports and clinical data, depending on the device class
- Importer’s wholesale license and company documents
- Fee payment proof
All foreign documents should be in English or properly translated, and notarised or apostilled where required.
Getting License Through the SUGAM Portal
The process is completely online.Following are the steps involved:
- Login to the SUGAM portal- Register yourself as an importer/authorised agent.
- Categorize the device- Check under which category, either A, B, C, or D does it fall.
- Fill Form MD-14- Enter manufacturer, importer and device details correctly.
- Upload your documents- Attach every required paper as per your device class.
- Pay the government fee- Complete the online payment and keep the receipt.
- Reply to queries- CDSCO may ask for more information, so respond quickly and clearly.
- Receive Form MD-15- Once approved, you get your import license.
You can track your application status on the portal throughout the process.
Medical Device Import License Cost
The government fees are based on the class of the device and the number of manufacturing units and the number of devices which you have applied for. The fees are estimated on the basis of US dollars, and they are relatively low for Class A and B devices and relatively high for Class C and D devices. The fees are estimated mainly on the basis of each manufacturing unit and on the basis of each device.
Since there can be variations in the regulations as well as the amount of fees, it is essential that you check the fees at the CDSCO website before making any payments. In addition to the government fees, there are other fees which you should consider.
Time Required for the Approval Process
This will depend on the class of your medical device as well as the quality of your application. The lesser the risk associated with your medical device, the less time your application will take to get approved. However, medical devices belonging to Classes C and D will take more time to get approved.
Validity of the Import License
Under the Medical Device Rules, the import license does not have a short fixed expiry. It remains valid unless it is suspended or cancelled, as long as you pay the retention fee at the prescribed interval. Check the current rules at the time of application for the latest details.
Common Mistakes to Avoid
- Selecting the wrong risk class
- Uploading unsigned or expired documents
- Mismatch between labels and application details
- Delaying replies to CDSCO queries
- Starting imports before receiving the license
Conclusion
Obtaining the Indian Medical Device Import License could be difficult to comprehend, the process becomes simpler when you classify your product properly and ensure that all documents as per SUGAM are kept in place. This will help save a lot of time and prevent any problems with the customs procedure.
For assistance regarding the documentation involved in the importation of medical devices in India, Certilize can guide you with the process and requirements.
Frequently asked questions
How to obtain import license for medical devices in India?
Registration on the SUGAM portal, filing of Form MD-14 along with the required document and fee, answering of queries of CDSCO and obtaining Form MD-15.
Is it compulsory to register under CDSCO for medical devices?
Yes, registration of all medical devices is compulsory.
What is Form MD-14?
It is the application form for import license.
What is Form MD-15?
It is the import license.
Who can apply for CDSCO medical device registration?
Foreign manufacturer of the medical device or its authorized agent or importer in India.
Can foreign medical devices be imported in India?
Yes, provided you have the import license.
