CDSCO (Medical Devices)

CDSCO License

CDSCO (Central Drugs Standard Control Organization) certification is an indispensable requirement for the manufacture, import, or sale of drugs and medical devices within India. Below are essential points elucidating the CDSCO certification process and its significance:

CDSCO Certification Process: Manufacturers or importers seeking CDSCO certification must submit an application to CDSCO, accompanied by requisite documents and fees. Subsequently, CDSCO scrutinizes the application, and upon meeting the prescribed standards, issues the certification.

CDSCO Standards: CDSCO delineates standards governing the manufacture, import, and sale of drugs and medical devices in India, encompassing facets like safety, quality, and efficacy. Compliance with these standards is imperative for obtaining CDSCO certification.

Validity of CDSCO Certificate: CDSCO certification holds validity for five years. Post this period, recertification is mandatory for continued sale of the product within India.

Benefits of CDSCO Certification: CDSCO certification assures adherence to requisite standards, thereby affirming the safety and efficacy of drugs and medical devices. Moreover, it instills trust and confidence among customers and stakeholders regarding product reliability.

Consequences of Non-Compliance: Failure to comply with CDSCO standards and certification requisites may result in penalties, fines, or legal repercussions. Additionally, non-compliance could tarnish a company’s reputation and lead to loss of business opportunities.