According to the regulations of the Drugs and Cosmetics Act of 1940 and Rules 1945, the Central Drugs Standard Control Organization, or CDSCO, is the official regulatory agency of the Indian medical device industry. Every country has an independent regulatory body that is part of the health ministry to manage all aspects of pharmaceuticals, including not-notified medical device manufacturing license and notified medical devices manufacturing license.
Non-Notified Medical Devices / New Medical Device - Meaning
In India, there isn’t any regulation for medical devices that are not listed on the official list of Notified Devices. These medical devices must be registered on the CDSCO portal. Foreign companies who wish to market such devices within India require the IAA (Indian authorized Agent).
The selected applications vary according to the type of device and characteristics of the applicant, their operation, and the approval from the home country. The CDSCO authorizes devices for testing, import, or manufacturing after thoroughly scrutinizing every application.
In conformity with the Medical Device (Amendment) Rules from February 2020 that was in effect from April 2020, all non- notified Medical Devices can register with the Central Licensing Authority (CLA) via the online medical device system.
The main difference between Notified Medical Devices and Non-Notified Medical Device is that non-notified medical devices are any medical device that hasn’t been listed under the Notified medical device categories in the gazette issued by the Indian government.
Classification of the Non Notified Devices/ New Medical Device
1866 medical devices fall under the category of non-notified devices as of today. “Newly Notified Devices” are also classified into 24 categories of medical devices along with the 3 IVD categories. Based on the risk that is that each device carries that is Notified as well as Newly Notified devices are classified into four classes which are A B C and D. There are Class A low-risk devices as well as high-risk Class D devices.
Non-notified Medical Devices Licensing Authorities
Licensing authorities comprise authorities such as the State Licensing Authority (SLA) and the Centre Licensing Authority (CLA) as per the DGCI.
Non-Notified Medical Devices License Requirements
The parties involved, such as the suppliers, manufacturers, and importers, need to have the license for manufacturing, Wholesale license, or retail license relevant to handling medical devices that are not notified.
Documents Required for the List of Newly Notified Devices / New Medical Device Registration
To be included in the list, manufacturers need to submit basic information, like the model of the manufacturer and the country where it was made, as well as information about the device and an ISO 13485 certificate and an ISO 13485:2016 certificate, Free Sales Certificate (FSC) or the certificate of Free Sales (CFS) (granted by the Country of Origin (COO) for devices that are imported) and an undertaking from the person who is applying.
There is no major difference in the forms used for Notified Medical Devices that are Notified and Non-Notified. The main documents needed for the registration of non-notified medical devices are identical to notified devices’ ISO certification 13485:2016.
Regulatory Documents For New Medical Devices License / Registration
A request for approval must be submitted to the SUGAM portal for Medical Devices for Non-Regulatory Devices. A comprehensive checklist of documentation has been released by the regulatory body that is required to be filed for processing and approval with appropriate permissions.
1. Name and Complete address of the Importer / Manufacturer
2. Product-Related Details:-
- Name and address of the Manufacturing site
- Generic Name and Brand name
- Model No.
- Intended use
- Class of Medical Device
- Material of Construction
- Shelf Life
- ISO 13485
- Dimension (if any)
- Sterile or Non Sterile
- Storage Conditions
- Pack sizes
3. Free sale certificate from country of origin. (Only for Importers)
4. Undertaking duly signed by the manufacturer or importer stating that the information furnished by the applicant is completely true and authentic.
Non-Notified Medical Devices Regulatory Compliances
Manufacturers of non-notified medical devices must submit an optional registration under the CDSCO. The government has not imposed any fees for voluntary registration. The original deadline for the registration of non-notified medical devices was September 30, 2021. The government has extended one year on the demand of different parties.
Non-Notified Medical Devices Initiating Licensing Activities
It is suggested that all stakeholders apply for the Non-notified Medical products registration as soon as possible. Before the deadline, the manufacturers, as well as importers and sellers, must submit ISO and FSC certifications at no cost for registration.
Non-Notified Medical Device Registration Number on Labels
According to RULE 19E, the Medical Devices (Amendment) Rules 2020, an application made with CDSCO, the Central Licensing authority on the online SUGAM Portal. CDSCO shall issue a Registration number to each Importer from the Manufacturer who will be listed on the label of Medical Devices.
Non- notified Medical Device Registration Timelines
The new medical device’s prescribed deadline for the manufacturer/importer is 4 – 6 Days.
Process Guidelines Non-Notified Medical Device Registration in India
Medical Device Amendments
The CDSCO made a change on the 11th of February 2020, which included, in addition to the mentioned 37 notified devices, the CDSCO will also be notified of all other devices that include devices, apparatus equipment, implants, and appliances regardless of whether they are used either in combination or as a stand-alone device for different purposes, such as diagnosis or prevention, treatment, alleviation of any illness as well as investigation, replacement or modification of the anatomy and other things are regulated by this law.
- These regulations are referred to as “the Medical Devices (Amendment) Rules in 2020.
- The rules will come into force on the 1st of April, 2020.
- In the Medical Devices Rules. The Medical Devices Rules. (hereinafter being referred to as the rules) After Chapter III is inserted, the next Chapter III A shall be inserted
The non-notified medical device registration process under this chapter is on a voluntary schedule for 18 months, starting from 1st April 2020 until the 1st of October in 2021.
The procedure to get registration for devices that aren’t notified in the Medical Device Amendments would be like this:
Step 1: Check Gazette Notification
Suppose a company decides to register its products in India. In that case, it must read the CDSCO’s gazette notices to know whether the product falls into an un-notified or notified category.
Step 2: Appointment of India Agent
The manufacturer/importer must appoint an Indian Agent to handle the documentation submission and help to obtain a registration code for the non-notified device.
Step 3: Compilation of Documents
The importer/manufacturer must create all of the documents listed below:
- Name of the business or company or other people who import devices for medical use, specifications, and guidelines for the specific medical device
- The details of a medical device
- Certificate of conformity of ISO 13485 standard accredited by the National Accreditation Board for Certification. Organizations or International Accreditation Board for Certification Bodies or International Accreditation Forum regarding medical devices that meet this standard.
- FSC Country of Origin
- The importer signs a contract to confirm that the information provided by the applicant is accurate.
Step 4: Process and Verification
After the documents have been submitted, the CDSCO will issue an identification number for the specific medical device. The importer then has to write this number on the product’s packaging. This is because the Central Licensing Authority will verify the documents at any time and investigate the safety and quality-related failures and complaints. Suppose the company fails to conform to the provisions of the new regulations. In that case, The Central Licensing Authority may cancel the registration number or suspend it for a certain period of time.
Step 5: Importation
The manufacturer is allowed to import their devices into India through an Authorized Indian agent.
Voluntary Registration of Non-Notified Medical Devices by 1 October 2021
Medical Devices that have not been registered as non-notified are classified as drugs for manufacture or Importer according to notification no. G.S.R. G.S.R. (E) from CDSCO must voluntarily register with CDSCO after 18 months of 1. April 2020. The Said License Number must be used on all labels of the Medical Devices.
Mandatory Registration of Class A and Class B Devices by 1 October 2022
Devices not registered or classified as drugs for the Manufacturer or Importer following notification no. G.S.R. (E) or (E) in CDSCO for Class A and Class B must be ratified via the registration certificate of CDSCO. After this time period import/manufacturing license is required.
Mandatory Registration of Class C and Class D Devices by 1 October 2023
Devices and devices that have not been registered as non-notified are classified as drugs for manufacture or Importer according to notification no. G.S.R. (E) or (E) (E) of CDSCO for Class C and Class D must be ratified via a registration certificate issued by CDSCO. After this time period import/manufacturing license is required.
Essential Tips for New Medical Devices
Applicants who are seeking a registration number on a voluntary basis must ensure that these requirements are met:
- The applicant must possess the Free Sale Certificate in case of importation and the ISO 13485 Certificate.
- If the legal status of the medical device has yet to be established, clarification should be sought from the regulator. This should be completed before the submission of the VRN application is submitted.
- The medical device must be classified within the category if the regulator does not specifically regulate it.