The processes required by this Schedule, which are applicable to the medical device and in-vitro diagnostic medical device, but which are not performed by the manufacturer are the responsibility of the manufacturer and are accounted for in the manufacturer's quality management system. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 131 of 248 ...

1.5 It is emphasized that the quality management system requirements specified in this Schedule are in addition to complementary to technical requirements for products. 1.6 Manufacturers of components or parts of finished devices and in vitro diagnostic medical devices are encouraged to use appropriate provisions of this Schedule as guidance.

THE BUREAU OF INDIAN STANDARD (BIS) Is a national standards body in India that operates under the Ministry of Consumer Affairs, Food, and Public Distribution. It plays a vital role in ensuring the quality and safety of products and services. Its main function is to formulates and promote standards to ensure the quality and reliability of products, covering a wide range of industries and sectors. I ...

THE FOOD SAFETY and STANDARD AUTHORITY OF INDIA (FSSAI) Plays a pivotal role in ensuring food safety and hygiene standards across the country. Some of the key functions of FSSAI include laying down rules for food safety and quality standards to ensure the production, distribution, and consumption of safe and wholesome food. Accredited Consultants Pvt Ltd (ACPL) serves as a regulatory consultant, ...