For all the sale and distribution of medical devices including in-vitro diagnostic devices must obtain the license of MD 41 & MD 42 for effective business. The license ensures that the distribution of medical devices is legal and passed as per the standards of CDSCO.
So, to enter this medical device industry without any barrier you must understand the license you need to apply under which application and license grant.
In this blog, you will go through the terms MD 41 and MD 42 that are required for the free sale & distribution of Medical Devices.
What is an MD 41 and MD 42 License?
MD 41 is an application form for the grant of the registration certificate to sell, stock, exhibit or order for a sale or distribution of medical devices including in-vitra diagnostics. The State Licensing Authority will issue, approve, or reject the application presented in Form MD-41 (Application for Grant of Registration Certificate to Sell, Stock, Exhibit, or Offer for Sale or Distribute a Medical Device, Including an In Vitro Diagnostic Medical Device).
MD 42 is the legal medical device registration certificate issued by the state licensing authority to the retailer and the distributor of the medical devices including in-vitro devices. It is a nnext process after the application form filled fof MD 41. This ensure that you are working as per the CDSCO standards to regulate the medical devices.
Why Is It Importance To Obtain MD 41 and MD 42 License?
MD 41 & MD 42 is important if you are a wholesaler, retailer, and stockiest of medical devices, and this license helps build trust in the products you sell, safe and quality medical devices. The further more importance of this MD 42 license is as follows:
- Regulatory Compliance – Through this it ensure that the imported medical devices meets the standards set by the CDSCO (Central Drugs Standard Control Organization). It is mandatory for all the medical device distributor to ensure that they are working as per the regulatory standards of indian laws. Without this license you are not allowed to distrribute any medical devices. If you do this then it is a illegal activity.
- Ensuring Public Safety – One of the primary reason to obtain the license of MD 42 is to ensure the public safety. It ensures that the product is safe to use and selling under the section of CDSCO guidenlines.
- Quality Control and Standards – The license guarantees that the medical devices being imported are subject to rigorous scrutiny to ensure high quality and efficacy. This ensures that the device meet the both international and national quality standards.
- Building Trust in the Market – When you obtain a license then this will help you to build a trust in the market and boost number of sales. It ensures the consumer that the product is safe to use and authorized by regulatory authorities, ensuring that the products meet all the legal and safety requirements.
- Business Expansion and Opportunities – This will help you to boost the business expansion and opportunities to access large indian healthcare market. this license allows foreign manufacturers and distributors to establish themselves in the market while complying with Indian laws and regulations.
- Legal Protection – When you obtain this MD 41 and MD 42 license then this will ensures legal protection to businesses by ensuring they are operating within the bounds of Indian laws. It helps the business to avoid penalties, fines and onfiscation of products for operating without the required licenses.
How To Apply For MD 42 License?
To obtain the MD 42 license in india for the distribution and sale of medical devices you have to follow the basic procedure or need to consult with the medical devices registration consultants. The steps to obtain license as follows:
1. Fill the Application Form MD 41
First you need to fill an application of MD 41 and submit ot the online and offline process. Some states have their own online portals for filing MD 41 i.e. Nivesh Mitra (U.P.), CDSCO (Gurugram). but most of the states having offline process means you need visit State FDA office and submit the application.
2. Prepare Necessary Documentation
As per the mentioned below list attach all the required documents. The documents are mandatory to attach if you omit any of the documents then your application must be rejected.
3. Submit The Application Fees
To obtain the license you must submit the application fee as per the government guidelines. You can simply submit the application fee in two ways online or offline.
4. Audit Process
After submitting the MD 41 application, a Drug Inspector will review your premises. If you go with the offline process then Drug Inspector may visit your location for an inspection. For the audit of the application you need to vist the FDA office for a document verification.
5. Issue The License
When the drug inspector find that all the thinks as per the guidelines they will issue the MD 42 license. If they find any issue then they will conduct an inquiry or inform to the concern business.
NOTE – Primarily, the State Licensing Authority Issues the MD 42 License after checking all the important items. Furthermore, when convinced that the applicant has followed all the rules and regulations of Medical Devices, the license is provided in Form 42.
What Documents are Required for an MD 42 License?
Documents which are needed are mentioned below –
- Details of the applicant or firm including its constitution, along with identification proof, such as an Adhar card or PAN card.
- Documentary evidence in respect of ownership or occupancy on rental of the premises.
- Educational Qualification Details of competent technical staff.
- Experience Details Of competent technical staff.
- A brief description of other activities carried out by the applicant, namely, storage of drugs, medical items, food products, stationeries, etc., or any other activities carried out by the applicant in the said premises
- Self-certificate of compliance concerning Good Distribution Compliance.
- An undertaking to the effect that the storage requirement to sell, stock, exhibit, or offer for sale or distribute a medical device will be complied with
Any other Documents like GST, Trade License, Premise Plan, etc.
What is the Government Fee for an MD 42 License?
The government fee for the MD 42 is Rs. 3000, which is required from everyone applying for it. But it’s liable to change according to modifications in updates, so directly talk to the experienced in the field.
Who Needs To Fill MD 42 License?
- Wholesalers of medical items and in vitro diagnostics (IVD)
- Retailers of medical devices and IVD
- Stockists of medical devices and IVD
What is the Renewal Cost for MD 42 License?
The Client has to pay Rs.3000 for the renewal of the Medical Device Registration Certificate MD 42.
Who Qualifies As Compititent Technical Staff For MD 42 Registration Service?
- A person who holds a degree from a recognized University/Institution, Who is a registered pharmacist, or Who has passed the intermediate examination with one year of experience in dealing with the sale of medical devices.
- The Candidate should appoint a Competent Technical Staff to direct and supervise the sales activity of medical devices. The Competent Technical Staff must hold the above educational qualifications and experience.
Why Amazon, Flipkart, and other E-Commerce Portals are Asking for an MD 42 License?
Amazon and Flipkart are requesting an MD 42 license, which is required to sell medical equipment in India. All medical devices imported, produced, or marketed in India require an MD 42 license. The CDSCO issued this license.
Expert Advice
A Medical Device Registration Certificate MD 42 is essential for Wholesalers, Retailers, and Stockists of medical devices. This MD 42 certificate is valid for 5 years. If you are a wholesaler and retailer you must carry the license. For more details and information directly talk to the experts through the mentioned number on the page.
What is a Wholesale License for Medical Devices in India?
India’s Medical Devices Wholesale License the Central Drugs Standard Control Organization (CDSCO) in India uses the CDSCO MD 41 form to register certain medical devices that have an Indian counterpart.
Is a Drug License Required for Medical Devices?
In India, only registered medical devices are regulated as pharmaceuticals under the Pharmaceuticals and Cosmetics Act of 1940 and the Rules of 1945.
What is the MD 42 License Used For?
The State Licensing Authority provides the MD 42 Legal Medical Device Registration Certificate to retailers, wholesalers, or stockists so that they can sell, store, exhibit, offer for sale, or distribute medical devices, including in-vitro diagnostic instruments.
Who is the Consultant for the MD 42 License?
ELT Consultancy is one of the best consultancies in the world, as they have all the experienced members on their team.
ls Medical Devices Online Without MD 42 Registration?
No, you can not sell Medical Devices without an MD 42 license.
