Medical Device Registration in India

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.

Upcoming Deadlines

Class A (Measuring and Sterile) and all B medical devices must have an Import License beginning 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. See below for more information on registering Non Regulatory products.

Class A Non-Measuring/Sterile Devices Now Exempt from Import Licenses

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.

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. 

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.