MD42 license for Selling Medical Devices in India | Apply Now
Registration Certificate for Selling, Stocking, and Distributing Medical Devices - MD42 License
At cdscoregistration.com, we assist individuals and businesses in obtaining the necessary Registration Certificate to legally sell, stock, exhibit, or distribute medical devices, including in vitro diagnostic medical devices, within India.
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On September 30, 2022, the Ministry of Health and Family Welfare (MoHFW) issued a notification, GSR 754 (E), amending the Medical Devices Rules, 2017. This amendment introduces the requirement for a Registration Certificate (Form MD-42) for the sale, stocking, exhibition, or distribution of medical devices, including in vitro diagnostic devices, in both retail and wholesale settings.
Key Highlights of GSR 754 (E)
Mandatory Registration: All entities involved in the sale, stocking, or distribution of medical devices must obtain a Registration Certificate (Form MD42) from the State Licensing Authority (SLA). This ensures compliance with the regulatory standards set forth by the Medical Devices Rules, 2017.
Application Process: To apply for the MD42 license, applicants must submit Form MD-41 along with the necessary documentation, including proof of premises, details of competent technical staff, and a self-certification of compliance with Good Distribution Practices.
Validity and Renewal: The Registration Certificate is valid indefinitely, provided the retention fee is paid every five years. This ensures continuous compliance and regulation of medical device sales.
Regulatory Compliance: The introduction of this registration requirement aims to enhance the regulatory oversight of medical devices, ensuring that only compliant and safe devices are available in the market.
How to Apply for a MD42 License?
To sell or distribute medical devices, you must apply for a registration certificate by submitting Form MD-41 to the State Licensing Authority (SLA). Our team of experts can guide you through this process to ensure a smooth and hassle-free experience
Requirements for Application: MD42 License
When applying for the MD42 License, your submission must include the following:
- Application Fees: As specified in the Second Schedule i.e Rs. 3000/-
- Good Distribution Compliance: A self-certification confirming compliance with Good Distribution Practices.
- Applicant or Firm Details: Identification proof such as Aadhar or PAN card.
- Premises Documentation: Proof of ownership or rental of the premises where the medical devices will be stored or sold.
- Competent Technical Staff: Details of the qualified technical personnel overseeing sales activities, who must meet one of the following criteria:
- Hold a recognized degree or diploma.
- Be a registered pharmacist.
- Have passed an intermediate examination with at least one year of experience in handling medical device sales.
- Business Description: A brief description of any other activities conducted at the premises (e.g., drug storage, food products, stationeries).
- Undertaking for Compliance: A declaration ensuring that the premises meet all necessary storage and safety standards for handling medical devices.
Approval Process:
Validity of MD42 license
A Registration Certificate (Form MD-42 license) is valid indefinitely, as long as the registration certificate retention fee is paid every five years.
Why Choose Us for MD42 license?
At cdscoregistration.com, we specialize in guiding businesses through every step of the medical device registration process. With our dedicated team of experts, including scientists, pharmacists, and legal professionals, we ensure a smooth, compliant, and hassle-free experience.
Difference Between Form 20B, 21B and MD42 license
Aspect | Form 20B / 21B | Form MD42 license |
Purpose | Wholesale license for drugs | Sell, Stock and Exhibit of medical devices |
Regulatory Framework | Drugs and Cosmetics Act, Drug Rules 1945 | Medical Devices Rules, 2017 |
Validity | Typically, valid for 5 years | Typically, valid for 5 years |
Frequently Asked Questions
MD-42 license for Selling Medical Devices in India | Apply Now
To apply for a registration certificate, you must submit Form MD-41 to the State Licensing Authority along with the following documents:
- Application fees (Rs. 3000/-).
- Self-certification of compliance with Good Distribution Practices.
- Applicant or firm’s details (such as Aadhar or PAN card).
- Proof of ownership or rental of premises.
- Details of competent technical staff responsible for sales, who must have a degree, be a registered pharmacist, or have relevant experience.
- A brief description of any other activities at the premises.
- An undertaking ensuring compliance with storage and safety standards.
The State Licensing Authority will review your application. If all requirements are met, you will receive a Registration Certificate (Form MD42 license) within 10 days. If the application is rejected, the reasons will be provided in writing.
If your application is rejected, you can appeal to the State Government within 45 days. The State Government will review your appeal and make a decision within 60 days.
A Registration Certificate (Form MD42 license) remains valid indefinitely, provided the registration certificate retention fee is paid every five years.
If you fail to pay the retention fee on time, you will be charged a late fee of 2% of the retention fee per month (or part thereof) for up to six months. If the fee and late charges are not paid within this period, your registration certificate will be cancelled.
Medical Device Registration Services MD42 license
Get expert support for CDSCO medical device registration. Contact us for a free consultation call today!
Get expert support for CDSCO medical device registration. Contact us for a free consultation call today!
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