Regulations for Medical Devices and Application to Plastics Suppliers in India
The Central Drugs Standards Control Organization (CDSCO) under the Ministry of Health and Family Welfare regulates the licensing, import, manufacture, and sale of medical devices into the Country. Approval can be facilitated by evidence of approval from the US FDA, the EU MDD (CE-Certificate) and approvals from Australia, Canada, Japan, and other countries. ISO Certification for specific manufacturing practices (ISO 13485) is also accepted. Device master files must contain details of good manufacturing practices including components and materials used in the device. It must also include the manufacturing and quality assurance processes, risk assessment, design verification, sterilization, stability, biocompatibility, and toxicological data associated with the materials, and production of the finished device.
Various fillers and additives can be added to plastics to tailor their properties for specific applications and performance requirements. Fillers and additives can provide flexibility, stiffness, hardness, conducting properties, colors, impact, toughness, thermal properties, moisture transmission and gas barrier properties, and surface properties. In addition,various degrees of chemical resistance, radiation resistance, and biocompatibility can be achieved.
