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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.
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.
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 File
|Device Master File
|Class A Medical Device
|Class B Medical Device
|Class C Medical Device
|Class D Medical 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.
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.
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, 2023, all Class A measuring/sterile, B, C, and D medical devices require an MD-14/MD-15 Import License with the CDSCO before importing into India.
Class A non-measuring/sterile do not require an Import License but do need to be registered through an online portal.
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?
Class A measuring/sterile, B, C, and D MD-14 Import License applications will typically require 6 to 9 months for their Device Master File and first Plant Master File (required for 1st registration at a manufacturing site) to be approved. Products with Reference Country approvals and predicate devices will experience a quicker review. For more information on predicate devices in India, please click here. Innovative devices with limited marketing history may also require a Subject Expert Committee meeting and/or additional clinical and post-market requirements.
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 for medical devices in India are valid for a period of 5 years. To renew the license, applicants must submit updated documents along with the required fees for Device Master File(s) (DMF) and/or Plant Master File (PMF). More information can be found here.
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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