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IVD Product Registration in India
IVD product registration in India is overseen by the Central Drugs Standard Control Organization (CDSCO). The new Medical Device Rules, 2017 significantly expands the number of IVD devices requiring full technical documentation in support of their registration applications. Formerly only the critical IVD devices required registration with complete device master file, prior to being placed on the market in India. Under the new Rules, a risk-based classification is provided for IVD devices and all test kits must obtain Form MD 15 prior to importation.
Required elements of the registration application include:
- Proof of reference country approval
- ISO 13485 certification of the manufacturing facility
- Full technical details as per the prescribed requirements of the device master file.
Further, performance evaluation reports from the National Institute of Biologicals (NIB) are required for IVD devices and test kits related to:
- Blood Grouping Reagent
- Blood Glucose Test Reagent
- ToRCH (Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus)
- Methicillin-Resistant Staphylococcus Aureus
- Entero Virus
- Marker for congenital disorder e.g. Screen test for Down Syndrome
- Sexually transmitted agent i.e. Treponema pallidum. Neisseria gonorrhoeae, Human Papilloma Virus, Herpes Virus
- Other life threatening infections/agents
Performance evaluation reports must be conducted by a local National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratory.
IVD Classification in India
In-vitro diagnostics are classified according to risk and fall into 1 of 5 categories, Class A (Non-Measuring/Sterile), Class A (Measuring/Sterile), B, C, or D. For the latest IVD classification guidance issued by the CDSCO, please click here to view IVD/Misc/196/2020, issued on October 25, 2023.
Registration Requirements for IVDs
The CDSCO processing fees vary by risk classification as per the table below. Processing times for Import Licenses are expected to take 6 to 9 months. Successful applicants will be issued an Import License (aka MD Form 15) which is valid for perpetuity, with retention fees due every five years.
For Class A non-Measuring/Sterile, only a registration is required through the CDSCO’s portal and can be immediately imported.
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.
|Plant Master File
|Device Master File
|Class A IVD (Non-Sterile and Non-Measuring)
|Only requires a Registration/Listing (No cost)
|Class A IVD (Sterile or Measuring)
|Class B IVD
|Class C IVD
|Class D IVD
Asia Actual can manage and submit Import License applications and local performance testing to ensure the efficient, timely and secure issuance of certificates. Contact Asia Actual about registering IVD devices in India.
India Regulatory Support
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