Regulatory

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.

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.

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.