Registration Certificate to Sell or Distribute A Medical Device

Recently The department of health and family welfare released a notification in relation to obtaining Registration certificate to sell, exhibit, or distribute medical devices including IVDs. The State Licensing Authority shall appoint a Licensing Authorities for the purpose of issuing registration certificate. 

The highlights of Notification for “ Registration certificate to Sell or Distribute A Medical Device” 

• Any person not holding a license under sub rule (1) & intends to sell medical devices shall obtain a “Registration certificate” as provided in these rules. 
• Competent person shall be graduate from recognized university, or the registered pharmacist can also work as competent technical staff or has passed intermediate examination or equivalent examination with one year experience in dealing with sale of medical devices. 
• The application shall be accompanied by documents like a self-certificate of compliance, documentary evidence in respect of ownership or rental premises etc. 
• If the state licensing authority will take 10 days to accept or reject the application. If the application is rejected the aggrieved person may prefer an appeal within 45 days from the date of receipt of such rejection. 
• Any person intending to sell, stock, or offer for sale or distribute medical devices including IVD shall make an application in Form MD-41 to SLA. 
• Registration certificate will be issued in Form-MD-42. 
• The registration certificate holder shall maintain an inspection book in form MD-43. 
• Separate records shall be maintained  
• The records shall be open to inspection by a medical device officer appointed under sub rule (2) of rule 18. 
• The medical device shall be purchased only from importer or licensed manufacturer or registered or licensed entity. 
• The registration Certificate holder shall provide adequate space and proper storage condition for storage of the medical device. 

The registration Certificate issued in Form MD-42 will be valid for 5 years from the date issue unless it is suspended or cancelled by SLA. This notification brings changes in other forms as in Form MD-14 paragraph 3 after the words “manufacturing license “the words “or Registration certificate “shall be inserted. Likewise in Form MD-15, In the Form MD –26, and Form-28 “ or registration Certificate “shall be inserted . 

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