Medical Device Regulatory
Medical devices are closely regulated by the Indian Government due to their growing demand and evolving technology. Devices are classified into Classes A, B, C, and D based on risk levels and are overseen by central and state authorities. The licensing process is simplified based on these classifications. For imports, an authorized Indian agent can apply for the necessary licenses as per government guidelines.
Medical Device Regulatory Service
NEW DEVICE- FIRST TIME IN INDIA
A medical device which itself or its predicate hasn’t yet been included in the medical devices list of CDSCO (Central Drugs Standard Control Organization) is considered a new medical device. Moreover, already registered devices vying to apply for new claims with respect to different implementation factors will also be treated as new devices
MEDICAL DEVICE CLASSIFICATION
Medical device has been classified into A, B, C and D categories depending upon the risk involved increases from A to D. Low risk devices like Thermometers and Blood Pressure Monitors whereas high risk devices include pacemakers, heart valves and others. License for class A devices is easy to obtain permissions as compared to class D devices.
Medical Device Licensing Forms
| Applicant | Risk/Class | Type of Licence | Forms |
|---|---|---|---|
| Importer | A, B, C, D | Importer License | Application: MD-14 Permission: MD-15 |
| Manufacturer | A, B | Manufacturing License | Application: MD-3 Permission: MD-5 |
| Loan License | Application: MD-4 Permission: MD-6 | ||
| Manufacturer | C, D | Manufacturing License | Application: MD-7 Permission: MD-9 |
| Loan License | Application: MD-8 Permission: MD-10 |
| Applicant | Risk/Class | Type of Licence | Forms |
|---|---|---|---|
| Importer | A, B, C & D | Clinical Investigation Permission | Application: MD-22 Permission: MD-23 |
| A, B, C & D | Import License | Application: MD-26 Permission: MD-27 | |
| A, B, C & D | Test License | Application: MD-16 Permission: MD-17 | |
| Manufacturer | A, B, C & D | Clinical Investigation Permission | Application: MD-22 Permission: MD-23 |
| A, B, C & D | Manufacturing License | Application: MD-26 Permission: MD-27 | |
| A, B, C & D | Test License | Application: MD-16 Permission: MD-17 |
Who Can Apply ?
An authorized Indian agent must be appointed for the same. This agent must have a license to manufacture (for sale or distribution) or wholesale License FORM 20B & FORM 21 B (sale or distribution) as per the CDSCO guidelines. The agent will make an application to get the grant of medical devices import license by applying through the Sugam online portal.
How To Apply?
As per the Medical Device Rule 2017, the process of approval from CDSCO is as follows:
Evaluation of the product, if it requires registration under MDR 2017 (Regulated/Non-Regulated).
If required, evaluation of classification (Class A, B, C, & D) based on the product risk category.
Preparation of documents as per the MD 14 checklist.
Appoint an authorized agent.
Online generation of application.
Approval/confirmation of the draft application by the authorized agent and submission.
Follow-up with the regulatory authority and query management if any.
Medical Device Import Approval in India is received.
WHY CHOOSE US
Medical Device Import License Fees
Validity of Import License
The import license (Form MD 15) remains valid permanently, provided the license retention fee is paid every 5 years as per the Second Schedule. If not paid, the Central Licensing Authority may suspend or cancel it.
Important Documents
Wholesale Licence
Power of Attorney
Free Sale Certificate
GHTF
Device Master File
Site Master File
The Government Timeline for Import License for Medical Device is 6-9 months.
Medical Device Manufacturing Service
Medical Device Manufacturing
New regulations have been introduced for the manufacturing of medical devices in India. Manufacturers of Class A and B devices must apply to the State Licensing Authority, while those producing Class C and D devices are regulated by the Central Licensing Authority. Additionally, CDSCO has outlined specific application fees for each category to streamline the licensing process.
Classification of Medical Device
Manufacturing License for Medical Devices from SLA/CLAA
The government grants licenses for manufacturing and loan applications for Class A & B medical devices, which are low-to-moderate risk, including in-vitro diagnostic devices. A manufacturing license is applied using Form MD-3 and granted through Form MD-5, while a loan license is applied using Form MD-4 and granted through Form MD-6. Applications are submitted to the State Licensing Authority (SLA). Required documents include a cover letter with application details, constitution...
Licensing for Class C (Moderate to High Risk) and Class D (High Risk) medical devices is managed by the Central Licensing Authority (CLA). Due to their high-risk nature, obtaining a manufacturing license involves a stringent process. Applications for manufacturing licenses are submitted to CDSCO using Form MD-7 and granted through Form MD-9. Loan license applications use Form MD-8 and are approved via Form MD-10. Required documents include a cover letter detailing the application,...
Manufacturers may require a test license to produce medical devices for testing, training, clinical evaluation, or demonstrations. The Central Licensing Authority grants this license for all classes of medical devices. Applications are submitted using Form MD-12, and approval is granted through Form MD-13. Supporting documents include a cover letter, details of the medical device, a brief on its composition and functionality, a statement on its purpose and benefits, and a justification...
Licensing for Class A (Low Risk) and Class B (Low to Moderate Risk) medical devices falls under the jurisdiction of State Licensing Authorities. Barrocyte Consultants assists manufacturers in filing applications with the respective state FDA. Companies manufacturing Class A and B devices must obtain a manufacturing license, while those seeking a loan license must apply separately. Applications are filed using Form MD-3 for manufacturing approval (granted via Form MD-5) and Form MD-4 fo...
Manufacturers may require a test license for producing medical devices intended for testing, training, clinical evaluation, or demonstrations. This license is granted by the Central Licensing Authority and applies to all classes of medical devices. Companies manufacturing medical devices in small quantities for clinical investigation, testing, evaluation, or training must apply for a test license from the Central Licensing Authority. Applications for Class A, B, C, and D devices must b...
How To Apply?
As per the Medical Device Rule 2017, the process of approval from CDSCO is as follows:
Preparation of documents as per MDR 2017
Online generation of application.
Online Submission at Sugam
Audit of Plant by Notified Body (Class A & Class B)
Inspection of Plant by CDSCO (Class C & D)
Follow-up with regulatory authority and Query management if any
Medical Device Import Approval in India is received
Medical Device Import Approval in India is received.
WHY CHOOSE US
Medical Device Import License Fees
Validity of Import License
The manufacturing license issued on Form MD 5 or Form MD 9 remains valid in perpetuity i.e., permanently, as long as the payment of license retention fee is done from time to time, as specified in the Second Schedule. The license retention should be paid each time before completion of the period of 5 years from the date of issue of the license unless it is suspended or cancelled by the State Licensing Authority or Central Licensing Authority.
Important Documents
Quality Management System Plan
Quality Manual
SOP’s
Device Master File
Layout Plan