The Medical Devices (Draft Amendment) Rules, 2022.

The dossier should contain a list of all materials of animal or human origin used in the device. For these materials, detailed information should be provided concerning the selection of sources or donors; the harvesting, processing, preservation, testing and handling of tissues, cells and substances of such origin should also be provided. Process validation results should be included to substantiate that manufacturing procedures are in place to minimize biological risks, in particular, with regard to viruses and other transmissible agents. Transmissible Spongiform Encephalopathies (TSE) or Bovine Spongiform Encephalopathy (BSE) Certificates should also be submitted.

Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers releases guidelines for the scheme “Strengthening of Pharmaceutical Industry (SPI)”

The Scheme has 3 components / sub-schemes: Assistance to Pharmaceutical Industry for Common Facilities (APICF), to strengthen the existing pharmaceutical clusters’ capacity for their sustained growth by creating common facilities; Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) to facilitate Micro, Small and Medium Pharma Enterprises (MSMEs) of proven track record to meet national and international regulatory standards and Pharmaceutical & Medical Devices Promotion and Development Scheme

The Medical Devices (2nd Amendment) Rules, 2022

The amendment provides that where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, United Kingdom United States of America, an import licence shall be granted to the applicant without carrying out clinical investigation.