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

The flags of all the ASEAN Member countries

Expedited Market Access Now Available in Philippines

Announced on September 6, 2022, FDA Advisory 2022-1576, the Philippines FDA has announced that the alcohol swabs with at least 70% isopropyl alcohol intended for antiseptic use now falls under the jurisdiction of the Center for Drug Regulation Research (CDRR) under Household Remedy Products.

India Grants Import License Grace Period for Class A/B Devices

Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices.
Class A Exempt Instruments

India Issues Draft Notification for Exempting Certain Class A Medical Devices

The Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) on 20 September, 2022 that, if formalized, would exempt Class A non-measuring and non-sterile medical devices.