Gunjan Verma - India

“The CDSCO has issued several classification guidance documents covering most medical disciplines to help the industry better classify their devices in India.”

Gunjan Verma
Managing Partner
Asia Actual India

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sign Up For Our Newsletter to Stay Informed

Sign Up

Indian Industry Association Drafting a Uniform Code for Medical Device Marketing Practices

Published on: October 10th, 2021

The Standing Forum of Medical Devices Associations, will prepare the draft code for ethical marketing of medical devices. The Representative of Medical Technology Association of India (MTal) will be the Convener for this work. Currently Medical Device Associations comply with the provisions of Uniform Code for Pharmaceutical Marketing Practices (UCPMP) formed in 2014, until separate code for ethical marketing of medical devices becomes operational. The draft Uniform Code, found here, is a voluntary code for pharmaceutical industry, which includes medical devices.

Since the Code for ethical marketing of Pharmaceuticals viz. Uniform Code for Pharmaceutical Marketing Practices (UCPMP) was formed in 2014, medical device industry had raised its concern that medical device is different from Pharmaceuticals and therefore a separate code should be formed for regulating the marketing practices of medical devices

While drafting the code, the Standing Forum may also focus in the following elements of the Code: –

  1. The code will differentiate between educational and promotional activities.
  2. Certain criteria will be formed on which scale of expenditure incurred during promotional or educational activities objectives will be dependent
  3. List the types of educational events and will define guidance around best practices for internal documentation
  4. Reporting, communication, grievance redressal and voluntary compliances
  5. Any other relevant aspect related to the Code

The standing Forum was required to submit the draft Uniform Code for Medical Devices Marketing Practices to Dop (Department of Pharmaceuticals) by 24th Sept 2021 and the same is in the process of discussion and finalization.

Come Grow With Us

Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market.

Contact Asia Actual today with any questions on how these additional testing requirements may affect your market access to India.

Blog Posts

Australia SaMD Transition Deadline

Australia’s SaMD Regulatory Deadline

Beginning on November 1st, 2024, Australia's Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.
Thai FDA Documentation Exemptions for Concise and Full Regulatory Pathways

Thai FDA Regulatory Documentation Exemptions

March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.
Hong Kong MDD adds Singapore HSA to Reference Country List

Hong Kong MDD Adds Singapore as Reference Country

Starting April 2nd, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under MDACS.