The Ministry of Health and Family Welfare, Government of India has introduced an Official Gazette on 30th September 2022 which is the Medical Devices (Fifth Amendment) Rules, 2022.
Any person intending to sell medical devices exclusively shall obtain registration certificate in Form MD – 42. The Registration Certificate is a mandatory certificate to retailer and wholesalers from 30th September 2022.
In this article, we will discuss the process, fees, validity, documents and pre -requisites to obtain a Form MD – 42
Application Form MD – 41
Form MD – 41 is an application form submitted to the State Licensing Authority, Food and Drug Administration by the applicant for grant of registration certificate.
Registration Certificate Form MD – 42
A Registration Certificate also known as Form MD 42 is granted by the State Licensing Authority to a person who intends to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.
The State Licensing Authority, upon reviewing the documents and determining that the criteria of these rules are met, will issue a registration certificate in Form MD-42. On the other hand, if the Authority is not convinced of compliance, it will reject the application and provide written reasons for its decision.
If the application to obtain a registration certificate in form MD 42 for selling, stocking, exhibiting, offering for sale, or distributing a medical device is denied, the person affected by this decision has the right to file an appeal with the State Government. This appeal must be submitted within forty-five days of receiving notice of the rejection. After that, the State Government will hold an investigation and give the appellant an opportunity to be heard. After it is received, the appeal must be decided within sixty days.
Documents required for registration certificate in Form MD 42
- Application for Registration in Form MD 41
- Copy of Online Fee Receipt for Rs.3000/- (as generated from official website of Drugs Control Department, GNCTD)
- An undertaking towards the Good Distribution Compliance as well as providing proper storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device
- Details of applicant (Constitution) viz. Memorandum and articles of association and Copy of resolution, in case of company. Partnership deed, duly attested by Notary Public, in case of partnership firm. Trust deed, in case of trust / society.
- Photo ID proof of proprietor / partner / director of the firm,
- Site Plan and Key Plan
- Ownership details of Premises:
a) If Owned: Sale Deed, Tax Receipt, Electricity Bill,
b) If Rented: Registered Rent Agreement, Agreement along with ownership documents of landlord, as stated above.
* In case of village, Khasra Khatauni documents will be considered
- Details of technical person under whose direction and supervision the sales activity of medical device shall be undertaken, who shall possess the following educational qualification and experience, namely:-
- hold a degree from a recognized University/Institution; or
(b) is a registered pharmacist; or
(c) has passed intermediate examination or its equivalent examination from a recognised board with 3 – years experience in dealing with sale of medical devices;
(d) in case, the technical person is employee of the applicant firm, proof of his employment and undertaking towards his full time working with the firm
- Brief description on other activities carried out by applicant, namely, storage of drugs, medical items, food products, stationeries, etc., or any other activities carried out by the applicant in the said premises; and
- Documentary evidence w.r.t. to the firm involved in sale of medical devices prior to implementation of said notification viz: GST No/ Trade Licence at applied address.
Conditions of registration certificate in Form MD 42 to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.
- The registration certificate must be prominently displayed in a location within the premises where it is easily visible to the public.
- Sufficient space and appropriate conditions for the storage of medical devices, maintaining their quality and safety should be available.
- The Licensee shall maintain necessary temperature and lighting conditions in accordance with the specific requirements of the medical devices they are storing.
- Medical devices should only be procured from entities that are either licensed manufacturers, registered or licensed importers
- It is mandatory to keep distinct records of all purchases and sales of medical devices and shall be made available at the time of Inspection.
- All of the records must be kept up to date by the licensee for a minimum of two years after the last entry.
- The registration certificate holder must keep an inspection book in Form MD-43 to allow the Medical Devices Officer to record his observations and defects discovered.
Validity of registration certificate
A registration certificate granted under Form MD-42 will be valid indefinitely, on the condition that the holder pays the retention fee specified in the Second Schedule within five years from the date of issuance, unless it is suspended or cancelled by the State Licensing Authority.
In addition to the retention fee, there will be a late fee if the holder does not pay the retention fee by the due date. With a maximum of six months, this late fee is calculated at a rate of two percent of the retention fee for each month or part of a month. If the amount is not paid within the six-month period specified in the first clause, the registration certificate will be considered cancelled.
Government Fees of registration certificate
In order to obtain the Medical Device Registration Certificate MD-42, the applicant must pay ₹ 3,000/-. In addition, a ₹ 3,000/- retention fee needs to be paid every five years in order to keep this certificate valid.
Suspension and cancellation of registration certificate
The State Licensing Authority may suspend or permanently cancel a registration certificate holder’s certificate if the holder violates any of the laws or regulations related to the certificate. The certificate holder will have a chance to make their case and clarify why the suspension or cancellation is justified before such action is taken. The written justification for the Authority’s decision will be provided.
| GET YOUR MEDICAL DEVICE REGISTRATION CERTIFICATE IN FORM MD 42 CONTACT US: +91 8104691667 | info@thepermiso.com |
Frequently Asked Questions for Form MD 42 Registration Certificate
What is MD-41?
Form MD – 41 is the application form to be submitted to the State Licensing Authority, FDA along with necessary documents for Grant of Registration Certificate in Form MD – 42
What is MD-42 Registration Certificate?
The State Licensing Authority issues a Registration Certificate, also known as Form MD 42, to anyone wanting to distribute, sell, stock, display, or offer for sale any kind of medical device, including in vitro diagnostic devices.
Who needs to obtain MD-42 Registration Certificate?
Typically, manufacturers, importers, wholesalers, retailers, and stockists of medical devices must obtain this registration in order to lawfully distribute or sell them.
What is the Validity of Registration Certificate in Form MD 42?
Form MD 42 is valid for a period of 5 years and has to be renewed 3 months before expiry
What is the Government Fee for MD 42?
The Government fee is Rs. 3000/- for a period of 5 years.
What are different types of Medical Device?
Medical devices are categorized in 4 classifications based on the extent of risk
Class A Medical Device – Low Risk
Class B Medical Device – Low Moderate Risk
Class C Medical Device – Moderate High Risk
Class D Medical Device – High Risk
Do I need a Registration Certificate to sell Medical Devices online on Amazon, Flipkart or other e-commerce platform??
Yes, it is mandatory to obtain a Registration Certificate in Form MD 42 if you are an online seller of medical device. Many e-commerce platforms have asked the sellers to obtain a MD 42 Certificate.
I am an Importer of Medical Device. Do I need Form MD 42?
Yes. Any person importing medical device will have to mandatorily obtain a Form MD 42 Registration Certificate.
What are the consequences of non-compliance with MD-42 Registration requirements?
Penalties for failure to comply may include fines, registration suspension, or legal action.
How can I apply for a registration certificate in Form MD 42?
The Permiso is the leading consultant in providing Form MD 42. Our team of experts will help you in preparation of documents, document submission, plan layout preparation of the premise, liasoning with the officers, and final license copy. We have an established track record of successfully helping companies get MD 42 registration quickly and easily with Zero Rejection cases.
Conclusion
Retailers, distributors, and stockists of medical devices in India must possess the Medical Device Registration Certificate MD-42. This certificate can be renewed by paying the specified retention fee, and it will remain valid for an additional five years.
It is essential for any Indian retailer, wholesaler, or stockist of medical devices to have a valid MD-42 registration certificate. It guarantees both compliance with legal requirements and the efficacy and safety of the medical devices you provide.
Should you require additional support or guidance in obtaining the MD-42 registration certificate, do not hesitate to reach out to us. Contact us at +91-8104-691-667, or send your queries via WhatsApp to the same number.
