Indian Medical Devices Requirements
CDSCO Requirements According to the Specific Rules - CDSCO Requirements
Medical Device Registration in India
Government Authority (CDSCO)
Medical Device regulations in India are administered by the Central Drugs Standard Control Organization
(CDSCO), under Directorate General of Health Services in the Ministry of Health & Family Welfare. The
CDSCO serves as the National Regulatory Authority (NRA) of India. To register a Medical Device in India,
any non-local company must appoint a Local Agent or Manufacturer to interface with the CDSCO to
ensure regulatory compliance.
India Medical Device Regulations
● Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
● Medical Devices Rules, 2017
● Medical Devices (Amendment) Rules, 2020
● Medical Device Status
● Effective April 1, 2020, the status of a medical device expanded beyond the 23
previously notified medical devices, requiring that all medical devices be registered under
The Drugs and Cosmetics Act of 1940. Beginning October 1, 2022 all Class A and B
medical devices must have Import Licenses prior to importation. All remaining Class C
and D devices not already Notified will need to have Import Licenses by October 1,
2023.
Product Classification
Medical devices are classified into 5 categories; A (non-Measuring/Sterile), A
(Measuring/Sterile) B, C, and D based on risk level. The CDSCO fees for application processing
depends on the device classification. Except for Class A (non-m/s), the application process
requires 6 to 9 months. Class A (non-m/s) products must just be registered through the ePortal
and can begin importing almost immediately.
Applications for products unable to identify a predicate device will be considered ‘Innovative’
and will likely require additional time.
Once approved, an Import License (aka MD Form 15) is issued for each manufacturing site
listing the products approved. Click the following links to learn more classifying and grouping
your devices in India.
Classification Type Plant Master File Device Master File
Class A Medical Device US$1,000 US$50
Class B Medical Device US$2,000 US$1,000
Class C Medical Device US$3,000 US$1,500
Class D Medical Device US$3,000 US$1,500
Medical Device Registration in India
Government Authority (CDSCO)
Medical Device regulations in India are administered by the Central Drugs Standard Control Organization
(CDSCO), under Directorate General of Health Services in the Ministry of Health & Family Welfare. The
CDSCO serves as the National Regulatory Authority (NRA) of India. To register a Medical Device in India,
any non-local company must appoint a Local Agent or Manufacturer to interface with the CDSCO to
ensure regulatory compliance.
India Medical Device Regulations
● Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
● Medical Devices Rules, 2017
● Medical Devices (Amendment) Rules, 2020
Medical Device Status
Effective April 1, 2020, the status of a medical device expanded beyond the 23 previously notified
medical devices, requiring that all medical devices be registered under The Drugs and Cosmetics Act of
1940. Beginning October 1, 2022 all Class A and B medical devices must have Import Licenses prior to
importation. All remaining Class C and D devices not already Notified will need to have Import Licenses
by October 1, 2023.
Product Classification
Medical devices are classified into 5 categories; A (non-Measuring/Sterile), A (Measuring/Sterile) B, C,
and D based on risk level. The CDSCO fees for application processing depends on the device
classification. Except for Class A (non-m/s), the application process requires 6 to 9 months. Class A (non-
m/s) products must just be registered through the ePortal and can begin importing almost immediately.
Applications for products unable to identify a predicate device will be considered ‘Innovative’ and will
likely require additional time.
Once approved, an Import License (aka MD Form 15) is issued for each manufacturing site listing the
products approved. Click the following links to learn more classifying and grouping your devices in India.
Plant Master Device Master
Classification Type
File File
Class A Medical
US$1,000 US$50
Device
Class B Medical
US$2,000 US$1,000
Device
Class C Medical
US$3,000 US$1,500
Device
Class D Medical
US$3,000 US$1,500
Device
Medical Device Market Access Requirements
Effective from October 1, 2023, it is mandatory for all Class A (Measuring and Sterile) B, C, and D medical
devices to possess an MD-14/15 Import License for importation. The MD-14 application process
necessitates the submission of a comprehensive Device Master File (DMF) corresponding to each
product, along with a Plant Master File (PMF) detailing the manufacturing facility. Following a thorough
approval process, an MD-15 Import License will be granted to a local license holder for the
manufacturing site, encompassing a comprehensive list of all approved medical devices.
In accordance with the Circular (PDF) issued on October 12, 2023, it has been stipulated that all non-
Notified Class C and D medical devices listed in the mandatory registration program, and concurrently
undergoing a pending MD-14 application, are permitted to continue their importation activities for a
duration of six (6) months.
Class A Non-Measuring/Sterile Devices
On October 14, 2022, the Indian Ministry of Health and Family Welfare issued final notification G.S.R.
777(E) formalizing the exemption of Class A non-measuring and non-sterile medical devices from the
Import License (MD-15) process.
While Class A non-measuring and non-sterile devices won’t require an Import License, they will still
require registration and self-certification to certain standards. More information can be found here.
Medical Device Registration or Endorsements – Device Master File (DMF)
The registration process in India for imported devices is a largely a re-assessment of their existing
approval, utilizing the same documentation and evidence required in the reference country. This being
said, the CDSCO will pay very close attention to the predicate device comparison section of the
application. It will be important for manufacturers to carefully select the predicates compared to and
provide sufficient evidence for equivalence.
Quality Systems Conformity Assessment – Plant Master File (PMF)
An ISO 13485 certification is required to certify the quality system/s of the legal and/or actual
manufacturing facilities. To show conformity, manufacturers will need to submit a Plant Master File
(PMF) for each manufacturing site. Once approved, an Import License is issued and medical devices
approved at that site are added under the license. Therefore, manufacturers with 1 manufacturing site
will have 1 Import License while manufacturers with 3 sites will have 3 Import Licenses. Products
manufactured at 2 sites will require 2 PMF applications and are then listed on each Import License once
approved.
Registering Innovative or Novel Medical Devices
Medical devices that are novel to the Indian market in terms of materials, mode of action, or intended
use are considered ‘investigational devices’ and are subject to additional clinical investigation
requirements and review, including establishing safety and effectiveness through clinical investigation in
India. These additional requirements will be determined at a meeting with the CDSCO, called a Subject
Expert Committee (SEC), where they will ask additional questions and establish specific additional
requirements for the manufacturer and license holder to meet to maintain market access. More
information on registering Novel or Innovative devices can be found in our blog here.
Home Country or Reference Country Approval Requirements
Home country approval is not required but applicants will need to submit proof of a reference country’s
approval. Reference countries include the USA, Canada, the EU, Australia, and Japan.
Bureau of Indian Standards (BIS) Registration
The scope of BIS requirements has been broadened to encompass medical device-related products.
Non-compliant items, predominantly in the electronics category, will be stopped by Indian Customs. The
following list outlines potential components that, if integrated into imported medical
equipment/devices, mandate BIS certification for the medical devices:
Sr. 6 – Laptops/Notebooks/Tablets
Sr. 26 – Power Adaptors for audio, video & similar electronic apparatuses
Sr. 27 – Power Adaptors for IT Equipment
Sr. 40 – Visual Display Units & Video Monitors (Screen size up to 32 inch)
Sr. 49 – Storage battery
NOTE: Non-rechargeable batteries are not included in the above devices and are not affected by the
requirements.
More information on BIS registration can be found here
Validity and Renewal
Import Licenses need to be renewed every 5 years. License holders and manufacturers will need to
submit several updated documents and pay the DMF or PMF fees which are equal to the original
submission fees. More information on renewing Import Licenses can be found here.
License Holder Requirements
The License Holding Agent is granted Power-of-Authority, listed on local labeling, handles customs
clearance, and post-market vigilance. Post-market vigilance entails notifying the CDSCO and
Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SAE) occurring in India.
License Transfer
No license transfers are available under the current rules but more than 1 company can hold a license
for the same product.
Benefits of Using Asia Actual as Your Independent License Holder
● Sell directly to multiple regional distributors, avoiding mark-up by a national importer
● Increase transfer pricing
● Improve leverage in distributor negotiations/responses
● Add or change distributors as required
● Keep intellectual property away from local commercial agents
Contact Asia Actual for assistance with your medical device registration in India or to confirm the cost
and time lines that apply to your specific devices of interest. Asia Actual has experienced, bi-lingual
consultants in India to help you manage the application, importing, and post-market surveillance needs.
