BioState assists its clients in establishing infrastructure by building competencies for the stakeholders to develop and provide products and solutions facilitating the industry and nation at large in bridging the healthcare gaps. In order to legally manufacture medical devices or IVDs in India, a manufacturer needs to be adhere to the Indian regulations. From Manufacturing to the commercialization of the product.

Manufacturing plant layout design is the primary step for manufacturing plant setup. Medical Device Manufacturing plant must be compliant with the rules given by respective regulatory bodies like USFDA, CDSCO etc. Manufacturers of medical devices like IVD reagents, disposables and other medical devices, primary packing material & various pharma products have to design their manufacturing unit to meet cGMP requirements & other regulatory requirements.

Assist in coordination of an inspection if CDSCO selects your manufacturing site for an inspection/audit.

Our solutions in the Medical Technology space will help our clients, build strategic relationships with the Medical Technology Innovators and introduce recent technologies into the Indian Markets and mentor professionals.
Facilitate in introducing robust and effective Go-to-Market (GTM) strategies and effectively monitor them to derive desired results.

Our team identifies new technology in healthcare around the globe that have the potential to meet healthcare demands in India. The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body of India that
provides clearances of Drugs, Medical Device, IVDs. The expertise which we offer allows manufacturers to understand the regulatory of Medical Device, IVDs Registration Certification. This along with the Selection of distributors assists manufacturers to successfully commercialise in the Indian market.

A company which proposes to manufacture a medical device or IVD will have to register through Indian CDSCO (Govt authority body)