A distributor wins a hospital supply contract, receives its first consignment of catheters from a licensed importer, and is asked by the hospital’s purchase team for its registration certificate. It has a GST number, a warehouse and a sales team. What it does not have is a Form MD-42 certificate — and under the Medical Devices Rules, 2017, it should not have been stocking those catheters at all.
Since 30 September 2022, anyone in India who sells, stocks, exhibits, offers for sale or distributes medical devices, including in vitro diagnostic devices, needs either a sale licence or a registration certificate in Form MD-42. This guide explains who needs the certificate, how the Form MD-41 application works, the conditions that apply once it is granted, and where applications and compliance go wrong.
Where MD-42 comes from
The requirement was introduced by the Medical Devices (Fifth Amendment) Rules, 2022, notified as G.S.R. 754(E) on 30 September 2022 and in force from the date of publication. The notification inserted a new sub-rule 87(1A) and four new rules, 87A to 87D, into the Medical Devices Rules, 2017.
Before that amendment, Rule 87(1) applied the sale provisions of the Drugs and Cosmetics Rules, 1945 (Part VI, “Sale of Drugs other than Homoeopathic Medicines”) to medical devices. That route still exists: a wholesale or retail drug licence covers devices. Sub-rule 87(1A) added a second route for those who do not hold such a licence and intend to sell medical devices exclusively — they must obtain a registration certificate instead.
The timing was not accidental. CDSCO’s circular of the same date confirms that Class A and Class B devices came under the licensing regime from 1 October 2022. Many traders that had never needed a drug licence suddenly needed a legal basis to deal in devices.
Who needs MD-42 and who does not
Rule 87A is broad: any person who intends to sell, stock, exhibit, offer for sale or distribute a medical device, including an IVD, must apply. In practice the question is simply whether you already hold a sale licence that covers devices.
- You already hold a wholesale drug licence. CDSCO’s FAQ (Q143) confirms that a wholesale licence under the Drugs and Cosmetics Rules, 1945 covers stocking and distribution of medical devices. Rule 87(2) also keeps sale licences granted before the Rules took effect valid for devices.
- You trade only in devices and hold no drug licence. CDSCO’s FAQ (Q144) says a wholesale licence is not mandatory for such a trader, but a registration certificate in Form MD-42 is. This is the typical MD-42 applicant: device distributors, surgical and diagnostic suppliers, stockists and dealers.
- You are a licensed manufacturer selling your own products. Your manufacturing licence is the basis for that sale. A separate trading business, or a separate stocking premises, should be checked against Rule 87A on its own facts.
Two points are often missed. First, the requirement attaches to the premises: Rule 87A asks for proof of ownership or rental occupancy of the premises and an undertaking on storage, and the certificate names the address. A second warehouse needs its own consideration. Second, rules 87A to 87D contain no exemption by device class. If you deal only in low-risk Class A devices, do not assume you are outside the rule without checking it against your own products.
How to apply: Form MD-41
The application is made in Form MD-41 to the State Licensing Authority, through the Medical Devices online portal (CDSCO FAQ Q145–Q146). Rule 87A(3) lists what must accompany it:
- the fee specified in the Second Schedule — set at ₹3,000 by the 2022 notification;
- a self-certificate of compliance with respect to Good Distribution Compliance (the notification’s wording);
- details of the applicant or firm, including its constitution (proprietorship, partnership or LLP, company, society, trust), with identity proof such as Aadhaar or PAN;
- proof of ownership or rental occupancy of the premises;
- details of the competent technical staff who will supervise sales;
- a description of any other activity carried on at the same premises;
- an undertaking that the storage requirements for the devices will be met.
The form itself asks for the name, qualification and experience of the competent person, and is signed by a director, proprietor or partner.
The competent person rule
The competent technical staff member is the one requirement that causes real delay, because it depends on a person rather than a document. Rule 87A(3) accepts any one of three profiles:
- a degree from a recognised university or institution; or
- a registered pharmacist; or
- a pass in the intermediate examination or equivalent from a recognised board, together with one year’s experience in dealing with the sale of medical devices.
The person’s name and qualification are printed on the certificate. That makes them part of the registration, not a box ticked once.
The ten-day decision
After scrutiny of the documents, the licensing authority either grants the certificate in Form MD-42 or rejects the application with reasons in writing, within ten days of the application (Rule 87A; CDSCO FAQ Q147). A rejected applicant may appeal to the State Government within 45 days of receiving the rejection; the State Government is to decide the appeal within 60 days of receipt, after giving the applicant a hearing.
After grant: the conditions in Rule 87B
The certificate is quick to obtain. The conditions attached to it are where compliance is won or lost. Rule 87B requires the holder to:
- Display the certificate in a prominent place in the premises.
- Store devices properly — adequate space, and the temperature and lighting conditions each device requires.
- Buy only from legitimate sources — an importer, a licensed manufacturer, or an entity that is itself registered or licensed.
- Keep separate purchase and sale records, by invoice, register or electronically, showing the names and quantities of devices, the manufacturer or importer, batch or lot number, and expiry date where applicable.
- Make those records available to a Medical Device Officer, who may also take samples.
- Retain records for at least two years from the date of the last entry.
- Keep an inspection book in Form MD-43.
Validity, retention fee and cancellation
Under Rule 87C, an MD-42 certificate does not expire. It remains valid unless suspended or cancelled, provided the holder pays the retention fee in the Second Schedule — set at ₹3,000 by the 2022 notification — before five years from the date of issue. A late fee of two per cent of the retention fee applies for each month or part of a month, for up to six months. If the fee is still unpaid after that, the certificate is deemed cancelled.
Under Rule 87D, if the holder breaches the Drugs and Cosmetics Act, 1940 or the Rules, the licensing authority may, after giving an opportunity to show cause, suspend the certificate for a period — for all devices or only some — or cancel it. The holder can appeal to the State Government within 45 days.
MD-42 and import licences
The same notification changed import licensing. Rule 34(1) originally allowed only an authorised agent holding a manufacturing licence or a wholesale licence to apply for an import licence. The 2022 amendment added the words “or registration certificate in Form MD-42”. CDSCO’s FAQ (Q90 and Q95) confirms that an MD-42 holder can apply as an importer, including as a subsequent importer.
For an overseas manufacturer looking for an Indian authorised agent, that matters: a device-only distributor or regulatory firm with an MD-42 certificate is eligible, and the certificate is usually the quickest of the three qualifying documents to obtain. It must be in place before the Form MD-14 import application is filed.
The amendment also extended Rule 88, which lets a licensed seller supply invasive devices for implantation to a hospital against a delivery challan, to MD-42 holders. The storage conditions and the requirement to raise a cash or credit memo for devices used in surgery still apply.
Where this goes wrong
The competent person leaves. The certificate names a person. When that person resigns, the business is left with a certificate that no longer describes how it operates. Plan a replacement with a qualifying profile before the vacancy, and inform the licensing authority of the change.
Experience that cannot be proved. The intermediate-plus-experience route requires one year in the sale of medical devices. Experience in general trading or in pharmaceuticals alone may not be accepted as stated. Keep an experience letter that names device sales specifically.
Buying from an unregistered supplier. Rule 87B allows purchases only from an importer, a licensed manufacturer or a registered or licensed entity. A sub-distributor buying from a trader that has no MD-42 or drug licence is in breach on every invoice. Ask suppliers for their certificate before the first order and keep a copy.
Records without batch numbers. Many distributors invoice by product name and quantity only. The Rule requires batch or lot number and, where applicable, expiry date. Without them, a recall cannot be traced to your customers — and the records fail inspection.
A rented premises with no storage evidence. The application includes an undertaking on storage. If your devices need controlled temperature — many IVD reagents do — the premises must actually provide it, with records to show it.
Forgetting the five-year retention fee. A certificate that “never expires” is easy to forget. Missing the payment triggers a two per cent monthly late fee, and after six months the certificate is deemed cancelled. Put the fifth anniversary of the issue date in the compliance calendar on the day the certificate arrives.
Assuming one certificate covers every location. The certificate is granted for a named address. Before opening a new warehouse or branch, especially in another district or state, check with the authority responsible for that area whether it needs its own application.
Frequently asked questions
Is MD-42 issued by CDSCO or the state?
By the State Licensing Authority. CDSCO’s FAQ (Q145) confirms this. The application is filed online through the Medical Devices portal and routed to the authority for your area.
How long does an MD-42 certificate take?
Rule 87A requires the authority to grant or reject within ten days of the application, after document scrutiny. Incomplete documents or a query on the competent person will extend that in practice.
Do I need MD-42 if I already have a wholesale drug licence?
No. CDSCO’s FAQ (Q143) confirms a wholesale licence under the Drugs and Cosmetics Rules, 1945 covers stocking and distributing medical devices. MD-42 is the route for those who sell devices exclusively and hold no such licence.
Does MD-42 need renewal?
No. Under Rule 87C it is valid in perpetuity unless suspended or cancelled, but the retention fee must be paid before five years from the date of issue, or a late fee and, after six months, deemed cancellation follow.
Can an MD-42 holder import medical devices?
Yes, if appointed by the overseas manufacturer as authorised agent. Since the 2022 amendment, Rule 34(1) accepts an MD-42 certificate as a qualifying document for an import licence application in Form MD-14.
Medfins prepares MD-41 applications, checks competent-person and premises evidence before filing, and sets up the purchase and sale records Rule 87B expects. If you are starting to trade in devices, adding a warehouse, or preparing to act as an importer, contact our team or see our CDSCO licensing services.
