Welcome to Medical Devices Testing as per MDR 2017.
The Medical Devices Rules 2017 in India were implemented to regulate the import,
manufacture, distribution, and sale of medical devices in the country. These rules are
intended to ensure the safety and efficacy of medical devices and to protect the health of
The rules establish a regulatory framework for the classification, registration, and testing
of medical devices, and they also provide for the establishment of a central licensing and
registration system for medical device manufacturers and importers.
Additionally, the rules require that medical devices be labelled with specific information
and that they meet certain quality standards. Overall, the Medical Devices Rules 2017 aim
to ensure the availability of safe and effective medical devices in India.
AYUSH stands for Ayurveda, Yoga, Unani, Siddha, and Homeopathy. It is a term used to
refer to the traditional systems of medicine that originated in India.
- Ayurveda: is a system of medicine that emphasizes the use of natural remedies,
such as herbs and minerals, to prevent and treat diseases.
- Yoga: is a system of physical and mental practices that originated in India and is
designed to promote physical and mental well-being.
- Unani: is a system of medicine that is based on the teachings of the ancient Greek
physician Hippocrates and is widely practiced in India, Pakistan, and Bangladesh.
- Siddha: is a traditional system of medicine that originated in southern India and Sri
Lanka and emphasizes the use of natural remedies, such as herbs and minerals, to
prevent and treat diseases.
- Homeopathy: is a system of medicine that is based on the principle that "like cures
like" and uses highly diluted substances to stimulate the body's healing processes.
The Government of India has set up an independent department, the Ministry of AYUSH
(Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy) to promote the
development and practice of these traditional systems of medicine. The Ministry also
provides funding for research, education and training programs to develop and promote
these traditional systems of medicine.
AYUSH systems are widely accepted in India and are considered as a complementary and
alternative system of medicine. They are also gaining acceptance in other countries as
AYURVEDA PRODUCT TEST PARAMETERS
Ayurveda is a traditional system of medicine that emphasizes the use of natural remedies,
such as herbs and minerals, to prevent and treat diseases. The testing parameters for
Ayurvedic products may include:
- Identification tests: These tests are used to identify the botanical source of the
plant material used in the product, such as microscopy, chromatography, and
- Microbial contamination: These tests are used to ensure that the product is free
from harmful microorganisms, such as bacteria, yeast and mould.
- Heavy metal testing: These tests are used to ensure that the product does not
contain excessive levels of heavy metals, such as lead, mercury, and arsenic, that
can be harmful to human health.
- Pesticide residue testing: These tests are used to ensure that the product does not
contain harmful pesticide residues that can be harmful to human health.
- Assay tests: These tests are used to determine the amount of active ingredients in
the product, such as alkaloids, flavonoids, and saponins.
- Toxicity testing: These tests are used to evaluate the safety of the product by
testing its effects on animals or cell cultures.
- Clinical trials: These are used to evaluate the effectiveness of the product by
testing it in human volunteers under controlled conditions.
- Stability testing: These tests are used to determine the shelf life of the product and
the conditions under which it should be stored to ensure its effectiveness.
These are just some of the tests that Ayurvedic products may be subjected to, depending
on the product type, ingredients and intended use. These tests help to ensure that the
products are safe and effective for their intended use and meet the quality standards.