Import License
As per MDR 2017 the Imports/Manufacturing will be prohibited without a license from CDSCO effective 1st Oct for Class A& B devices and 1st Oct 2023 for Class C&D Devices.
How to get your Import License
Step-1 Get your Account made with CDSCO. Timeframe- 3-5 working days.
Step-2 Classify your Medical Devices as per MDR 2017
Step-3 Get the following documents ready from Principal:
| No. | Documents | Available YES/NO | Remarks |
| 1 | Duly apostilled/notarized copy of Free Sale Certificate from National Regulatory for India as well as for Notified Countries | Required Notarized | |
| 2 | copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years. | ||
| 3 | Notarized copy of Certificate supporting quality management system (ISO: 13485) | Required Notarized | |
| 4 | Notarized Full quality Assurance Certificate/CE type examinationCertificate/CE product quality assurance | Required Notarized | |
| 5 | Notarized CE design Certificate | Required Notarized | |
| 6 | Notarized Declaration of conformity | Required Notarized | |
| 7 | Plant Master File | ||
| 8 | Device Master File | ||
| 9 | Reference to predicate or previous generations of the device | ||
| 10 | Label and IFU | ||
| 11 | Device Design and Manufacturing process with flow chart | ||
| 12 | Essential Principles Checklist | ||
| 13 | Risk analysis and control summary | ||
| 14 | Design Verification and validation of the medical device | ||
| 15 | Biocompatibility validation data | ||
| 16 | Biological Safety (TSE/BSE) | ||
| 17 | Software verification and validation if software used | ||
| 18 | Animal studies Preclinical data | ||
| 19 | Stability validation data | ||
| 20 | Clinical evidence | ||
| 21 | Post Marketing Surveillance data | ||
| 22 | Batch Release Certificates or Certificate of Analysis of finished product for minimum 3 consecutive batches | ||
| 23 | Notarized copy of overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority. | Required Notarized | |
| 24 | Notarized Power of Attorney | Required to be authenticated by Indian Embassy in the country of origin | |
| 25 | Covering Letter | To be submitted by Authorized agent | |
| 26 | Wholesale Drug License | To be submitted by Authorized agent | |
| 27 | Medicinal Substance data if device contains Drug | ||
| 28 | Sterilization Validation data | ||
| 29 | Constitution details of Authorized agent |
Step-4 Upload the documents
Step-5 Get the Legal Form
Step-6 Submit Payment on Bharat Kosh
Step-7 Submit the Application to CDSCO
You will get the Import License in 3-9 months based on country of origin.
CDSCO Fees- For details see below
Site License Fees- USD 3000 for Class C&D, USD 2000 for Class B, USD 1000 for Class A
Device Fees for Class C&D Devices @ USD 1500 each device, for Class B Devices @ USD 1000, for Class A Devices @ USD 50
Consultancy Fees
Our Consultancy Fees @ INR 15,000 plus GST @18% PER DEVICE Family.
Discounts will be applicable @10% for 2-5 Device, @20% for 6-10 devices, @30% for more than 10 Devices payable in lump sum
The scope of consultancy will be as below:
- Advising on all the documents required from you and your principals.
- Examining all the documents.
- Uploading the documents.
- Drafting Cover note.
- Drafting response to any queries from CDSCO.
- CDSCO Fees are as above not INCLUDED.
- You will be required to pay the CDSCO fees before uploading of all the documents. It is immaterial whether the fees are provided by you or your principals.
Our fees will be payable in advance as import License takes 3 to 9 months.
Our bank details are as below:
Name of beneficiary- Technomed Services and Consultants Pvt Ltd.
Account Number- 14510200009613
Bank Name- Federal bank Ltd.
Branch- Nirman Vihar
IFSC- FDRL0001451
GST- 07AAFCT0835J1ZA
The consultancy will start three days from the date of receipt of Consultancy Fees.
Exempted Class A(Non-Sterile and Non-Measuring Devices)
Most of the Class A devices can now be imported by simple undertakings to be uploaded into the CDSCO AC on the Portal.
These devices consist of the following:
- All hospital Furniture including hospital beds, mattresses, Chairs, Tables, Lockers etc.
- Reusable Surgical Instruments.
- Bronchoscopes, Laryngoscopes etc.
- Surgical Cameras.
- Bio Feed back Devices
- X-Ray View Box
- PPE Equipment (Non-Sterile)- Gowns, Gloves etc.
- Physical Support Equipment, rehab and assisted devices including wheelchair, walker etc.
- All Class A Ophthalmic Devices.
- Class A ENT Devices
- All other Class A Devices of Dental and other departments.
Authorized Agent For Medical Device – Overview
A foreign company who doesn’t have its establishment in India, wants to enter India market, then they can appoint an authorized agent to register and market their products in India. An “Authorized Agent” means a person or entity in India authorized by the foreign company. The authorized agent will be responsible for the import and business activities of the foreign company in India including compliance to the provisions of the Drugs and Cosmetics Acts in all respects. Authorized Agent must possess a valid wholesale license meant for the sale and distribution of products or services in India and should be able to file an application to Central Licensing Authority for Medical Device registration in India.
TMSCPL can act as your authorized agent and provide end-to-end solutions to carry out the import of medical devices in India. The team of experts at TMSCPL facilitates the hassle-free one-time registration process and thus launch of medical devices in India in compliance with Indian regulatory requirements.
We will help you in the Entire Manufacturing License Process Chain as below:
Do you need assistance with application and licensing?
With TMSCPL, you will receive expert advice, 24 hour support, practical guidance and complete technical assistance right from the beginning till the very end of your penetration into the Indian market.