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CDSCO Certificate: Complete Guide for Medical Device Registration

 CDSCO CERTIFCATE CDSCO Certificate is required for medical device manufacturers to legally make, bring into the country or sell medical devices in India.  Knowing the registration process, the papers needed and the rules helps companies avoid delays and problems with following the law.  This guide tells how to get a CDSCO Certificate for medical device registration, who's able to apply what documents are needed, how long it takes and good ways to do it. Introduction Medical device makers often think that a good product is all that is needed to get into the market. In fact getting approval from the rules is just as important as the quality of the product. A company might spend years creating a diagnostic device only to have problems because the papers they provided were not complete. At Diligence Certifications this often happens. One medical device maker came to us after their application was stuck for months because the papers were not prepared properly. When the papers...

BIS Certification: Requirements, Process, Cost & Benefits in India 

  BIS Certification: Requirements, Process, Cost & Benefits in India  BIS Certification: Requirements, Process, Cost & Benefits in India  A BIS Certificate confirms that a product complies with the applicable Indian Standards issued by the Bureau of Indian Standards (BIS). Many products require a BIS Certificate before they can be legally manufactured, imported, distributed, or sold in India. Understanding the correct certification scheme, documentation, and approval process helps businesses avoid penalties, customs delays, and compliance issues. Introduction A leading consumer electronics importer contacted Diligence Certifications last year after one of its consignments was detained at the Indian customs. The goods in question had passed through a series of international quality tests and were already being sold successfully in several countries. However, Indian customs authorities rejected the delivery due to the total absence of a BIS Certificate. Consequent...