The Ministry of Chemical & Fertilizers (MoC&F) on September 06, 2024, notified regarding the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024.
The following has been stated:
• General Points:
o A Medical Device must not be promoted prior to receipt of the product approval (wherever applicable) by the Regulatory Authority, authorizing its sale or distribution as per the provisions of the Medical Device Rules, 2017.
o The promotion of a Medical Device must be consistent with the terms of documents submitted by the Companies for obtaining product registration or licenses to manufacture, import, distribute or sell these-Devices in India; and more specifically, with the Instructions for Use (IFU)/Directions for Use (DFU) of the relevant product.
o Product Information about Medical Devices must be up-to-date, verifiable and accurately reflect current knowledge or responsible opinion.
• Medical Representatives:
o The term "medical representatives means sales representatives, medical affairs or marketing professionals, clinical specialists including personnel retained by way of contract with third parties or any other company representatives who call on HCPs, pharmacies, pathology labs, research labs, hospitals, or other healthcare facilities in connection with the promotion of Medical Devices.
o The medical representatives must at all times maintain a high standard of ethical conduct in the discharge of their duties and comply with all relevant requirements of this Code.
o The medical representatives must not employ any inducement or subterfuge to gain an interview. They must not pay, under any guise, for access to a healthcare professional.
[Notification No 31026/23/2022-Policy]
