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India Issues New Sales License Requirement for Medical Devices
Published on: October 10th, 2022
New Licensing Rule for Formerly Non-Notified Devices in India
On September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOHFW) issued GSR 754(E) announcing new sales license requirements for entities importing and distributing formerly non-notified medical devices. This new legislation, referred to as the Medical Devices (Fifth Amendment) Rules, 2022, is meant for authorized agents/sellers/retailers who want to import, sell, stock, exhibit or distribute medical devices including in vitro diagnostic medical devices in India.
This certification runs parallel to the current requirement of having sales licenses from Forms 20B and 21B of the Drugs and Cosmetics Rules, 1945. Importantly, the holders of these licenses do not need to transition/migrate to the new medical-device-only licenses. However, if a manufacturer/distributor doesn’t have either a Manufacturing License for distribution or sale or a Wholesale License for distribution or sale, they must obtain a Registration Certificate in Form MD-42 to sell and distribute the medical devices. This also includes in vitro diagnostic medical devices. The State Licensing Authority will be responsible for issuing, approving or rejecting the application made in Form MD-41 (Application for Grant of Registration Certificate to Sell, Stock, Exhibit or Offer for Sale or Distribute a Medical Device Including in-Vitro Diagnostic Medical Device).
Manufacturers of all formerly non-Notified devices will need to check with their distributors to ensure compliance. More buyers and sellers of newly regulated medical devices will likely be impacted by this amendment. Previously, they were able to engage in sales without any requirement of licensing. Going forward, all medical device dealers/distributors will need to obtain Form MD-42 if they do not already have licenses from Form 20B/21B.
New Rule vs. Previous Rule
Previously, sellers of non-Notified products were exempt from the licensing requirement in India. This means many did not acquire licenses from Form 20B/21B. With the new rule, all medical devices are notified, and manufacturers must submit Form MD-42 to guarantee protection of their devices. Furthermore, foreign manufacturers will need to work with a certified (Forms 20B & 21B) local partner to submit MD-14 Import License applications.
These regulation changes have already been taking place in India: all non-Notified A and B Class devices were required to be registered by October 1st, 2022. Recently, on September 30th, the CDSCO announced a grace period of 6 months for non-Notified Class A and B with pending Import License applications (Form MD-14/15) to ensure no market interruption.
Now, remaining non-Notified Class C and D Class devices must be registered by October 1, 2023 or they may face market interruption. A full list of Notified products can be found here.
Impact of the New Sales License Requirement
Anyone who intends to sell, stock, exhibit, offer for sale or distribute a medical device, including in-vitro diagnostic medical devices must obtain the Registration Certificate mentioned in these rules.
The process for obtaining the certificate is as follows:
- Application for a Registration Certificate must be made with Form MD-41 to the State Licensing Authority (SLA).
- Submit a fee of 3000 rupees to the SLA.
- The SLA, after satisfactory review, will grant the Registration Certificate.
- If they do not find the application to be satisfactory, the SLA can formally reject the application by giving the reason for rejection in writing within ten days from the application’s date of submission. If this occurs, an appeal can be made within 45 (forty-five) days of the date of receipt of rejection.
Registration Certificate will remain valid in perpetuity as long as a retention fee of 3000 rupees is paid every 5 years.
Sales License Registration Certificate Conditions
- The registration certificate granted under rule 87A shall be displayed at a prominent place in the premises visible to the public.
- The registration certificate holder shall provide adequate space and proper storage condition for storage of the medical devices.
- The registration certificate holder shall maintain requisite temperature and lighting as per requirements of such medical devices.
- The medical devices shall be purchased only from importer or licensed manufacturer or registered/licensed entity.
- Separate records, in the form of invoice or register or electronic details including software of purchases and sales of medical devices must be retained. These records must show the names and quantities of such medical devices, names and addresses of the manufacturers or importers, batch number or lot number and expiry date (if applicable) shall be maintained.
- The records referred to in sub-rule (5) shall be open to inspection by a Medical Device Officer appointed under the sub-rule (2) of rule 18, who may, if necessary, make enquiries about purchases and sale of the medical devices and may also take samples for testing.
- All registers and records mentioned under these rules, shall be preserved for a period of not less than two years from the last entry, therein.
- The registration certificate holder shall maintain an inspection book in Form MD-43 to enable the Medical Devices Officer to record his observations and defects noticed.
In the said rules, in Appendix, after Form MD-40, Forms MD-41, MD-42 and Form MD-43 have been inserted. Please refer to the Gazette Notification for the formats.
In the said rule, words “or registration certificate” is added in Rule 88 (Supply of medical device to hospitals against delivery challan) in sub-rule (1), In Fourth Schedule, in Part I (Power of Attorney), Form MD-14 (Import License application), in para 3, sub-para (ii), in Form MD-15 (Import License), in para 1, in Form MD-26 (Application to import / manufacture of medical device which does not have predicate medical device), in para 3, sub-para (ii), in Form MD-28 (Application to import / manufacture of new in vitro diagnostic medical device), in para 3, sub-para (ii).
Come Grow with Us
Asia Actual has an office in India located in Delhi staffed by experienced, bilingual regulatory and commercial professionals that will address any questions or provide support. Please contact us to explore if this new program is appropriate for your devices.
Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.