MEDICAL DEVICE REGISTRATION IN INDIA

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 that do not currently require Import Licenses must still register their product(s) through an ePortal in a couple of days.

PRODUCT CLASSIFICATION

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. 

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.

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.

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.