Registration Certificate | Form MD – 42
A Registration Certificate or Form MD-42, is a certificate issued by the State Drug Control Authority to business who are involved in storage and trading for medical device. The Permiso team will provide comprehensive assistance, starting from the project’s paperwork through its successful completion.
1000+
Satisfied Clients
3000+
Project Completed
10+
Years in Business
Book a Free Consultation Call!
A Registration Certificate, also known as Form MD-42, is a Certificate issued by the State Drug Control Authority to an applicant who intends to sell, stock, exhibit, or offer for sale or distribution a medical device, including an in-vitro diagnostic medical device. On September 30, 2022, the Ministry of Health and Family Welfare (MoHFW) notified the Medical Devices (Fifth Amendment) Rules, 2022, to further revise the Medical Device Rules (MDR), 2017.
The State Licensing Authority shall appoint Licensing Authorities to issue registration certificates / Form MD 42. Any person who intends to sell, stock, exhibit, or offer for sale or distribute a medical device, including an in vitro diagnostic medical device, must apply to the State Licensing Authority in Form MD-41 for a registration certificate to sell, stock, exhibit, or offer for sale or distribution.
The State Licensing Authority shall, after scrutinising documents and being satisfied that the requirements of these rules have been met, grant a registration certificate in Form MD- 42, or if not satisfied, reject the application for reasons to be recorded in writing.
A registration certificate issued in Form MD-42 shall be valid in perpetuity unless suspended or cancelled by the State Licensing Authority before the completion of the period of 5 years from the date of its issue.
Procedure for Obtaining a Registration Certificate in Form MD - 42 in India:
- Obtaining Login credentials: To obtain a Registration Certificate in Form MD - 42, the applicant must first register in an online portal and create a Login ID and Password, which will be sent to them through SMS on the mobile phone.
- Documentation: The applicant must produce documents and upload them online accordingly. All documents must meet the rules of Medical Devices (Fifth Amendment) Rules, 2022.
- Fees: The applicant must pay the required fees online as specified in Second Schedule of The Medical Devices Rules, 2017.
- Inspection: Following the submission of documentation, the Drug Inspector visits the premises where the drug license is to be obtained to authenticate the location and verify the documents.
- Issue of Form MD - 42: Post Inspection by the Drug Inspector, the licensing authority verifies the documents and inspection report submitted by the Drug Inspector and will grant or reject the license
Pre - Requisites / Documents required for Registration Certificate in Form Md - 42 in India:
- Self-certificate of compliance with respect to Good Distribution Compliance
- Information about the applicant or firm, including its constitution, as well as identifying proof, such as an Aadhar card or a PAN card;
- Documentary evidence in respect of ownership or occupancy on rental of the premises
- Details of competent technical staff, who shall possess the following educational qualification and experience, namely: (a) hold a degree from a recognised University/Institution; or (b) is a registered pharmacist; or (c) has passed intermediate examination or its equivalent examination from a recognised Board with one-year experience in dealing with the sale of medical devices;
- A brief explanation of the applicant's other activities, such as the storage of medications, medical items, food products, stationery, and so on, or any other activities carried out in the stated premises;
- An undertaking that the storage requirements for selling, stocking, exhibiting, selling, or distributing a medical item will be met
Obtaining a Registration Certificate in Form MD- 42 can be time-consuming and the licensing procedure consists of steps that require a clear and thoughtful method. Any blunder during the registration procedure may result in the applicant being denied the license. We reduce the likelihood of application rejection and ensure that licenses are issued quickly and without complications.
You can apply for a Registration Certificate in Form MD- 42 / Renewal of Certificate / Product Addition / Duplicate License or Surrender of License through M/s. The Permiso and obtain the application reference number within 2 days. If you have any issues or facing any difficulty with the application, you can call +91 8104691667 or email us at info@thepermiso.com
Book a Free Consultation Call!
REGISTRATION CERTIFICATE Procedure
