While giving an interview, the Union health minister, Mansukh Mandaviya, said, “Indian medical devices industry has the potential to grow at 28 per cent each year to reach $50 billion by 2030. He also mentioned that the central government is planning to boost further India’s strengths of skilled manpower, and ease of business through its industry-friendly rules which offer a huge market.” The medical device sector is very huge, which is followed by a bread classification such as electronic equipment, implants, consumables and disposables, surgical instruments and In-Vitro diagnostic reagents. In the recent years, we have seen a massive evolution in the IVD industry to support different applications such as the screening, diagnosis and monitoring of chronic and infectious diseases. There is a large panel of diagnostic technologies that are currently available on the IVD industry. To put it simply, In-vitro means ‘in glass’, which implies these tests are conducted in test tubes. Therefore these tests are performed on the patient to detect their disease, condition and infection. These tests also include next-generation sequencing tests, which scan a person’s DNA to detect genomic variations.
A large panel of diagnostic technologies is currently available in the IVD market. It ranges from simple lateral flow assays (LFA) intended for self-testing to complex solutions integrating active devices used by central laboratories. IVD products also include reagents, accessories intended for use with IVD devices as well as software.
Classification of Medical Devices Pertaining To In-Vitro Diagnostic
The safety, quality, and performance of these IVD medical devices are regulated under the Drugs and Cosmetics Act of 1940 and Drugs and the Cosmetics Rules of 1945. IVD medical devices are classified into number of classes as per intended use and risk associated with them, and these four classes are: A (Low risk), B (Low moderate risk), C (Moderate high risk), and D (High risk). This classification is based on the intended use. The risk associated with IVD medical devices and other parameters is enlisted in the First Schedule of MDR of 2017.
Mentioned below is the list of medical devices pertaining to In-vitro diagnostic with their risk category;
|S. No||IVD Devices||Risk Class|
|1||Alcohol body fluid analyser||A|
|2||Amino acid analyser||C|
|3||Bilirubinometry analyser||A & C|
|5||Chemiluminescent immunoassay analyser||A|
|6||Chloride coulometric titration analyser||A|
|8||Clinical Chemistry analyser||A|
|11||Glycated hemoglobin analyser||A|
|12||High-performance liquid chromatography analyser||A|
|13||Identification and antibiotic susceptibility analyser||A|
|16||Lipid profile analyser||A|
|17||Nitrogen body fluid sample analyser||A|
|20||ABO/Rh (D) blood grouping analyser||A & D|
|21||Blood cell count analyser||A|
|22||Blood coagulation analyser||A & C|
|23||Blood group/ antibody screening analyser||A|
|25||Erythrocyte sedimentation analyser||A|
|26||Flow cytometry analyser||A|
|28||Osmotic fragility analyser||A|
|30||Blood gas analyser||A & C|
|32||Platelet aggregation analyser||A|
|34||Enzyme immunoassay (EIA) analyser||A|
|35||Fluorescent immunoassay analyser||A|
|39||Particle counting immunoassay analyser||A|
|40||Photometric immunoassay analyser||A|
|41||Antimicrobial susceptibility analyser||A|
|42||Blood culture analyser||A|
|45||Micro-organism identification analyser||A|
|46||Nucleic acid amplification (PCR) analyser||A|
|47||Yeast/fungi identification analyser||A|
|48||Gas chromatography analyser||A|
|49||Mass spectrometry analyser||A|
|50||Nephelometry immunoassay analyser||A|
|51||Fecal occult blood immunoassay analyser||A|
|52||Spermatozoa /semen analyser||A|
|53||Blood smear cassettes||A|
|54||Blood smear instrument||A|
|55||Blood tube mixer||A|
|56||Blood component separator||A|
|57||Blood collection tube||A|
|61||Magnetic particle separation instrument||A|
|62||Microbial incubator/imaging instrument||A|
|63||Microplate seal roller||A|
|65||Microscope slide coverslipper||A|
|66||Microscope slide hybridization/denaturation incubator||A|
|67||Microscope slide maker/ stainer||A|
|68||Microscope slide washer||A|
|69||Nucleic acid sample preparation instrument||A|
|70||Side-mounted tissue dissection system||A|
|71||Specimen processing instrument||A|
|72||Cancer cell marker/ morphology image analysis software||C|
|73||Cancer risk assessment interpretative software||C|
|74||Cardiovascular risk/probability assessment interpretative software||C|
|75||Congenital defect/syndrome risk assessment interpretative software||C|
|76||Human genomic analysis interpretative software||C|
|77||Laboratory instrument/analyser application software||A|
|78||Microbial identification interpretative software||A|
|79||Osteoporosis risk assessment interpretative software||A|
What Are The Driving Factors Of The IVD Industry?
Recent technological development and automation are changing the way we understand a disease and treat it. We have entered an era where we can detect or predict the disease with more accurately. Now it’s very easy for our doctors to detect any disease at its early stage, not even this it is very easy now to check how an individual’s body will respond to a drug.
Following are some of the key driving factors of the IVD industry:
- Personalized care
- It helps in rapid disease identification
- It Improves quality of life and healthcare advancements
What Are The Challenges Being Faced By The IVD Industry?
The advancement of technologies and the ever-changing healthcare ecosystem might seem overwhelming to some. It is very tough to keep up with all the regulations and sustain yourself in the market. Given the scope and the velocity of these changes, it is very tough for the makers to keep up with competition from the emerging market and the difference in the customer behaviour.
Here are some of the key challenges faced by the IVD industries:
- Adoption risk
- Reimbursement risk
- Limited market intelligence
- Limited growth in the market
- Product development takes time, while technology and consumer expectations increase at a much faster rate
Governing Authorities in India
The medical device regulatory procedure was entirely altered by the Medical Device Rules of 2017. CDSCO, which stands for The Central Drugs Standard Control Organisation, is the National Regulatory Authority of India. It is managed by the Directorate General of Health Services under Ministry of Health & Family Welfare. CDSCO is responsible for implementing all the policies and acts of state drug licensing authorities.
For the manufacture of class A/B devices, a license or loan license against the application is granted by the State Licensing Authority. While for manufacturing class C/D devices, the license or loan license is granted by CLA. These licenses remain valid in perpetuity, unless suspended or cancelled if the license retention fee is paid before the completion of 5 years from the date of issue.
So all the manufacturers of class A and class B medical devices, the license against the application is granted by the state licensing authority; on the other hand, for the manufacturer of class C and class D medical devices, the license against the application is granted by CLA. Therefore for all the manufacturers or the importers of the IVD medical devices, it is crucial to register their products before start marketing them in India.
Medical Device Registration
Applications for IVD medical devices must be filed through the online SUGAM portal, which CDSCO also uses to manage applications. Mentioned below is a step-by-step process for CDSCO registration. All the importers, as well as the makers, must adhere to the following procedure before entering into the IVD industry.
- First step is to determine whether your product requires registration or not.
- After this the applicant has to appoint an authorized Indian agent for CDSCO registration for IVD medical devices.
- Submit the application under Form 40 with all the required documents.
- Obtain a registration certificate in Form 41
- After the documents are submitted, CDSCO will get back to the Indian agent with a query letter (if any). If the responses given by the agent are satisfactory to CDSCO, the licence will be granted.
- The registration certificate is valid for a term of three years.
- Obtain import licence number.
- A Form-10 has to be applied at CDSCO. The application has to be made under Form 8 along with Form 9 (Which mentions the registration certificate number.
Eligibility Criteria to Be an Authorised Indian Agent (AIR)?
To enter into the IVD industry all the manufacturers or the importer must appoint AIR in order to proceed with the process of registration.
- Must be a resident of India
- Must have relevant experience in the healthcare industry
- Must hold power of attorney to submit medical device registration documents to CDSCO
- Must hold wholesale drug licenses in forms 20B and 21B.
Documents Required For the Registration
Following is the exhaustive list of documents required for the CDSCO registration for IVD medical devices:
- Application form for registration
- Challan TR6
- ISO 13485
- A copy of the Power of Attorney
- An Undertaking by the applicant stating that all the information provides is true and accurate
- Certificate of quality assurance
- C.E. Design accreditation
- Declaration of conformity
- Schedule D(I)
- Master Plant File
- Device master file
- Free sale certificate
Medical devices, particularly the IVD industry, have proven their importance in the fight against the corona pandemic in the last two years. We have seen how the IVD industry was at the forefront of this fight against the pandemic. It was the main hero in fighting this battle.
Read Our Article: Parameters For Classification Of IVD Medical Devices