State License Authority To Accept Hard Copy Of Application

Now the DCs means drug controllers need to accept hard copy of the application to issues registration certificates to trade medical devices and IVDs, which has been announced by the Union health ministry as an alternative to drugs sale license for these devices.  

CDSCO has received various representation regarding the implementation of medical devices rules 2022, which was notified on September 30th,2022 stating that their application in hard copy is not being accepted by the State License Authority (SLA) for registration.  

According to the notice issued, “all State license authority are requested to accept the application in hard copy and dispose of the application expeditiously on priority and also to ensure uninterrupted access/supply of such medical devices” said Somani. 

The Medical Devices (Fifth Amendment) Rules, 2022, added a provision for a Registration Certificate to sell, stock, exhibit, or offer for sale or distribute a medical device, including in vitro diagnostic medical devices, as an alternative to a Drugs Sale License, with effect from September 30, 2022. 

As per the rule, the applicants can apply for a grant of a registration certificate in form MD-41 to the concerned State License Authority and State License Authority (SLA), after satisfying the requirements, shall issue the registration certificate in form MD-42 to sell, exhibit or distribute medical devices. To solve the ambiguity of the form numbers and the procedure of registration medical device regulatory consultant  provide proper guidance to the applicants and complete the step-by-step process, so that the applicants easily get the registration certificate.  

the MoHFW has inserted the provision so that for those who have the registration certificate on Form MD-42, they may also apply for the import license. Rule 34. Of MDR2017, explains the procedure to apply for a grant of import license where authorized agent is eligible to apply for the license, similarly rule 87, deals with provision for the sale of medical devices, a sub rule has been inserted to mandate that any person who does not hold a license and intend to sell medical devices, shall obtain a registration certificate as per the rules. 

The conditions of the registration certificate for the sale or distribution of medical devices, which mandates that: 

• proper storage conditions for the storage of the medical devices and adequate space need to be provided by the certificate holder. 
• Certificate holder need to maintain the required temperature and lighting as per the requirement of the medical devices  
• The registration certificate should be displayed at a prominent place on the premises visible to the public. 
• Medical devices shall be purchased only from the importer or licensed manufacturers or registered or licensed entities, among others. 

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You might be worrying about how to register into Form  MD- 41  ?

recently CDSCO.gov released a news regarding online submission of form MD-41 ,which resolves the ambiguity and provide clear and simple guidelines for filling the form . you can check the reference link here and contact us for more details .

references : 

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTIxNg==

References: 

https://thehealthmaster.com/2022/11/02/dcgi-to-sdcs-accept-hard-copy-of-application-for-registration-of-medical-devices/