Quality & Manufacturing
How our diagnostic products are made, licensed and documented.
Verify for yourself
Licences and certificates
-
CDSCO manufacturing licence
- Issued by
- Central Drugs Standard Control Organisation
-
GMP certified
-
ISO 9001:2015 certified
- Issued by
- QVA Certification
Quality management
Medonica Healthcare Pvt. Ltd. is ISO 9001:2015 certified and GMP certified, and holds a CDSCO manufacturing licence for its in vitro diagnostic products.
Our quality system covers how we develop, manufacture and release our products. Every product we publish has its specifications, specimen type, storage conditions and shelf life stated on its product page, so that buyers and laboratory teams can check them before they order.
Facility and capabilities
Our plant is in Agra, Uttar Pradesh, near UPSIDC. Our rapid test kits are developed in-house, and the membrane coating for them is also done in-house. Our biochemistry reagents are made in-house, in our own approved manufacturing setup.
Our blood collection tubes are made in a sterile clean-room environment. Additives are applied by automated spraying, and the tubes are assembled on an automatic assembly line.
Our haematology analyzers and point-of-care haemoglobin meter are supplied under the Medonica name by our manufacturing partners.
Testing and inspection
Performance review
Sensitivity and specificity figures for each rapid test kit are reviewed and signed off by our QA team before they are published.
Reference intervals
Reference intervals for our biochemistry reagents are reviewed by our QA team against published kit literature.
Sterility
Blood collection tubes are UV sterile.
Labelling of limits
Storage conditions and shelf life are stated for every product.
Traceability and documentation
Each product page states its catalogue number where one applies, its specimen type, storage conditions and shelf life. Rapid test kits are supplied with instructions for use.
For tender or audit documents, including copies of our licence and certificates, please send a request through the enquiry form and we will reply directly.
Regulatory approach
In India, in vitro diagnostic medical devices are regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017. Medonica Healthcare Pvt. Ltd. holds a CDSCO manufacturing licence for its in vitro diagnostic products.
The intended use of each product is stated on its product page and in its instructions for use. Test results should not be the sole basis for a clinical decision.
Questions from procurement and tender teams
Where can I verify your licence and certificates?
They are listed at the top of this page. For copies of the documents, send a request through the enquiry form.
Do you supply through the Government e-Marketplace (GeM)?
Yes. We regularly supply Government of India buyers through the GeM portal. For tender documents, write to sales@medonicahealthcare.com.
Which products do you manufacture yourselves?
We develop and manufacture our rapid test kits, biochemistry reagents and blood collection tubes in Agra. Our haematology analyzers and haemoglobin meter are supplied under the Medonica name by our manufacturing partners.
How long do your rapid test kits and reagents last?
Rapid test kits have a shelf life of 24 months and are stored at 2 to 40 °C. Biochemistry reagents have a shelf life of 12 months. The storage condition for each product is on its product page.
Where can I see the performance figures for a rapid test kit?
Each kit's page lists its sensitivity and specificity, stated as manufacturer-stated and signed off by our QA team.
How do I request a quotation?
Add the products to your enquiry list and send the form, or write to sales@medonicahealthcare.com. We reply to you directly.
Need documents for a tender or audit?
Ask for licence copies or a quote and we will reply to you directly.
Request documents or a quote