Center New Regulations for Medical Device Sales: What Store Owners Need to Know

All retailers selling thermometers, condoms, face masks, spectacles, or any other medical devices must now register with the state licensing authority, as per the amendment to the medical device rules. These new regulations aim to improve traceability of medical devices, particularly in cases of recalls.

To obtain a license under the new regulations, retailers must demonstrate adequate storage space, proper temperature and lighting conditions, and must purchase devices only from registered manufacturers or importers. They are also required to maintain records of customers and device batch or lot numbers for two years.

Additionally, retailers must provide details of “competent technical staff,” defined as individuals with a degree, registered pharmacists, or with at least one year of experience selling medical devices.

Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AIMED), expressed satisfaction with the acceptance of most recommendations in the notification, particularly the allowance for experienced individuals to continue selling medical devices.

However, Nath raised concerns about the practicality of record-keeping for all retailers, such as grocery stores or small vendors selling masks and condoms.

The registration, unless suspended or cancelled, will be valid “in perpetuity” with a retention fee of Rs 3,000 paid every five years.

The notification also stipulates that the licensing authority must process applications within 10 days and provide a written explanation for rejections. Applicants can appeal to the state government within 45 days of rejection.

Existing medical stores, stockists, and wholesalers are exempt from the registration requirement.

Rajiv Singhal, general secretary of the All India Organisation of Chemists and Druggists (AIOCD), clarified that medical stores with existing licenses are not required to re-register under the new regulations.

There are approximately 9.5 lakh medicine retailers in the country.

Singhal also noted that large distributors of medical devices, such as X-ray machines, will also need to register under the new regulations, filling a previous regulatory gap.