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Medical Device Registration in India
Government Authority (CDSCO)
Medical device registration in India is overseen 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.
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. Medical devices that do not currently require Import Licenses must still register their product(s) through an ePortal in a couple of days.
Medical devices are classified into 4 categories; A, B, C, and D based on risk level. The CDSCO fees for application processing depends on the device classification. Regardless of device classification, the application process requires 6 to 9 months. 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 Regulatory Pathways
All medical devices must be either registered or have an Import License and a complete list of product types that require an Import License is found at the bottom of this page. These “Notified” device categories must obtain an Import License by submitting a Device Master File (DMF) for each product and a Plant Master File (PMF) for each manufacturing site. Once approved, the medical devices are registered under the Import License associated with the primary manufacturing location.
All Class A and B medical devices must have an Import License by October 1, 2022 to maintain market access. On September 29, 2022, the CDSCO released a Circular announcing a 6 month grace period for Registered Class A/B devices that have submitted an Import License application. This grace period ensure there’s no interruption to business activities for manufacturers waiting for their Import License application to be approved. Our article on the topic can be found here.
Remaining non-Notified Class C and D devices will have until October 1, 2023 to obtain an Import License and will need to register as a Non Regulatory Product in the meantime.
Some Class A Devices May Be Exempt from Import Licenses
On September 20, 2022, the CDSCO released a draft notice that would exempt Class A non-sterile and non-measuring products from the Import License requirements if formalized. More information can be found here.
Import Licenses – 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 manufactures 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.
Registration of Non Regulatory Products
All non-notified medical devices (Class C and D devices not listed below) must be submitted under the new mandatory registration process and are referred to as “Non Regulatory Medical Devices.” The Non Regulatory registration process will generate a file number the same day which the importer must mention on the label of the medical device prior to placing the devices on the market. This Non Regulatory registration process is only available until October 1, 2022 for Class A and B devices and October 1, 2023 for Class C and D.
Devices registered during the registration period benefit from a truncated application that involves administrative documents such as Free Sales Certificate from the country of origin, ISO 13485 certificate, as well as basic product information. The mandatory registration process carries no government processing fees but may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by the requirement for the mandatory Import License.
Draft Guidance Issued for Exempting Certain Class A Medical Devices
On September 20, 2022, the Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) that, if formalized, would exempt Class A non-measuring and non-sterile. In an endeavour to simplify market access for low-risk medical devices, the Ministry of Health and Family Welfare (MOHFW) through this draft notification has inserted Chapter IIIB in the MDR 2017 to exempt Manufacture/ Import Licensing of Class A medical devices that are non-sterile and non-measuring.
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. For more information, please see our article on the topic 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.
Australia – Canada – European Union – Japan – United States
Validity and Renewal
Import Licenses do not expire, so long as listing fees are paid every 5 years.
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.
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.
Frequently Asked Questions
Do I need to register my medical device in India?
Yes, as of October 1, 2021, all medical devices require registration or an Import License with the CDSCO before importing into India. Some products, called Notified medical devices, required a more extensive registration requiring a Device Master File, called an Import License. Non-Notified Class A and B medical devices will require an Import License by October 1, 2022 while Non-Notified Class C and D medical devices must have one by October 1, 2023. A full list of Notified product categories are found at the bottom of this page.
Who can submit submit applications in India?
A local entity must submit applications, hold the license, and correspond with the CDSCO on behalf of foreign manufacturers. License Holders will then importing the products and deliver to the manufacturer’s distributor(s).
How long does it take to register my medical device in India?
Non-Notified Class C and D medical devices can currently register through the e-portal. Notified (all Class A and B) medical devices will typically require 6 to 9 months for their Device Master File and 1st Plant Master File (required for 1st registration at a manufacturing site). Products with Reference Country approvals and predicate devices will experience a quicker review. For more information on predicate devices in India, please click here.
How much does it cost to register my device in India?
Registration fees in India depend on the product’s classification and whether the manufacturing site has already been registered. Each manufacturing site will be issued an Import License that then has new products (DMFs) added to it as they’re approved.
Device Master Files (DMF):
- Class A: US$1,000
- Class B: US$2,000
- Class C and D: US$3,000
Plant Master Files (PMF) – 1 PMF is required per manufacturing site
- Class A: US$50
- Class B: US$1,000
- Class C and D: US$1,500
How long are medical device licenses valid in India?
Import Licenses are valid for 5 years and are renewed through a simple administrative process.
Does the license holder need to be a part of the importing process?
Yes, the license holder needs to be part of the importing process and will need to be on the labeling. Independent license holding allows the manufacturer to work with one company for importing and labeling.
Is there an expedited review pathway in India?
No, there is not an exclusive expedited review pathway in India but in general, products approved by multiple reference countries with a predicate device already on the India market will experience a quicker review. The CDSCO doesn’t require home country approval but does require approval from a Reference Country for foreign manufacturers. Acceptable reference countries include the USA, Canada, Europe (incl. UK/Switzerland), Australia, and Japan.
Is ISO 13485 required for medical devices in India?
An ISO 13485 certification is required to certify the quality system/s of the legal and/or actual manufacturing facilities as part of the Plant Master File (PMF) application process.
Is Home Country approval required?
The CDSCO doesn’t require home country approval but does require approval from a Reference Country for foreign manufacturers. Acceptable reference countries include the USA, Canada, Europe (incl. UK/Switzerland), Australia, and Japan.
Do documents need to be translated as part of the application process?
No, all documents can be submitted in English.
India Regulatory Support
Gunjan’s Regulatory Hint
“While the new medical device regulations are transitioning, it can be difficult to understand what requirements apply when. We can help.”
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Latest Market Updates
- India Issues Final Notice Exempting Certain Class A Medical DevicesNovember 14, 2022 - 10:06 am
- Identifying Predicate Devices in India, Taiwan, China, Japan, and KoreaOctober 25, 2022 - 12:28 pm
- India Issues New Sales License Requirement for Medical DevicesOctober 10, 2022 - 12:10 pm
- India Grants Import License Grace Period for Class A/B DevicesSeptember 30, 2022 - 11:48 am
- India Issues Draft Notification for Exempting Certain Class A Medical DevicesSeptember 29, 2022 - 2:35 pm
Important Documents and Links
List of Notified Medical Devices in India
- Disposable Hypodermic Syringes
- Disposable Hypodermic Needles
- Disposable Perfusion Sets
- IVD Devices for HIV, HBsAg, HCV
- Cardiac Stents
- Drug Eluting Stents
- Intra Ocular Lenses
- I.V. Cannulae
- Bone Cements
- Heart Valves
- Scalp Vein Set
- Orthopaedic Implants
- Internal Prosthetic Replacements
- Blood Grouping Sera
- Ligatures, Sutures and Staplers
- Intra Uterine Devices (CuT)
- Tubal Rings
- Surgical Dressings
- Umbilical tapes
- Blood/Blood Component Bags
- Ablation Devices
- Organ Preservation Solution
- Blood Pressure Monitors
- Digital Thermometers
Newly Notified Medical Devices
- X-Ray Machines (Effective April 1, 2021)
- CT Scan Equipment (Effective April 1, 2021)
- MRI Equipment (Effective April 1, 2021)
- PET Equipment (Effective April 1, 2021)
- Defibrillators (Effective April 1, 2021)
- Dialysis Machines (Effective April 1, 2021)
- Bone Marrow Cell Separators (Effective April 1, 2021)
- All Implantable Medical Devices (Effective April 1, 2021)
- Ultrasound Devices (Effective November 1, 2021)
- Disinfectants and insecticides specified in Medical Device Rules, 2017
- All Class A and B beginning October 1, 2022
*Seek guidance on application of categories