Compliance & Product Regulatory ApproVals

Central Drugs Standard Control Organization (CDSCO)

Self-Certification of Class A Non-Sterile & Non-Measuring Medical Devices

CDSCO under the Ministry of Health And Family Welfare has recently issued notification to smoothen the licensing process for Class A (nonsterile and/or non-measuring) medical devices. Several manufacturers are waiting for the audit from the government licensing authorities. Online registration with self-declaration would make this
transition process easier. An online portal has been established under which the manufacturer must give the following information followed by allotment of Registration number in online portal.

  1. Name and address of the manufacturing site.
  2. Details of the medical device like generic
    name, brand name, intended use, material of construction, shelf life, etc.
  3. Undertaking

This Registration Number can be added to the label for sale in India. The applicant needs to maintain the records of manufacturing/ import along with its sales or distribution. The Licensing Authorities may verify the records, documents at any point of time and investigate quality or safety related failures or complaints.

Please click here to check complete notification

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