In the field of wellness and spinal care, safety, quality, and regulatory approval are extremely important. The Ceragem Master V4, one of the most advanced automatic thermal massage beds has received approval from Central Drugs Standard Control Organization (CDSCO) as a Class B Medical Device in India and obtained Indian Standards Institution (ISI) Mark Certification from Bureau of Indian Standards (BIS). In addition to the Ceragem Master V4, the Ceramix S1 Thermal Mat has also received ISI Mark certification from the BIS.
The Central Drugs Standard Control Organization is the national regulatory authority, operates under the Ministry of Health and Family Welfare, responsible for approving drugs and conduct of Clinical Trials. CDSCO is constantly thriving upon to bring out transparency, accountability, and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
Before a medical device is approved in India, it must comply with the requirements specified under the Medical Devices Rules, 2017, regulated by the Central Drugs Standard Control Organization (CDSCO). The approval process includes evaluation of technical documentation, risk classification, safety and performance data, manufacturing information, and regulatory compliance.
BIS is the National Standard Body of India for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. BIS has been providing traceability and tangibility benefits to the national economy in a number of ways – providing safe reliable quality goods; minimizing health hazards to consumers; promoting exports and imports substitute; control over proliferation of varieties etc. through standardization, certification and testing.
The Ceragem Master V4 is designed to provide massage, heat, stretching, acupressure on the back through advanced automatic thermal massage technology. It has been approved under Class B Medical Device; it is intended to provide Therapeutic Massage to the occupant of the bed for the treatment of body aches and pains. Certification from the Bureau of Indian Standards provides additional assurance regarding product quality and safety which means that the device meets regulatory safety standards and is considered safe when used properly.
Ceragem has continuously focused on combining technology, research, and wellness solutions to support spinal health. These certification and approval reflect the brand’s ongoing effort to maintain high standards in both product development and regulatory compliance.
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The Editorial Team at Ceragem India is a group of content professionals, researchers, and reviewers responsible for maintaining the quality and integrity of information published on the Ceragem India blog. Our focus is on delivering accurate, well-structured, and responsible content related to wellness, lifestyle, health awareness, and organizational initiatives.