UCMPMD Guidelines 2026: Self-Declaration, Disclosure and Compliance Guide
Overview
Medical device companies in India need to consider not only product approvals and licensing but also how their products are promoted and how they interact with healthcare professionals.
The Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024 provides a framework for ethical and transparent marketing practices in the medical device industry. The Code covers areas such as promotional claims, evaluation samples, CME and CPD activities, interactions with healthcare professionals, marketing expenditure disclosure and complaint handling.
The Department of Pharmaceuticals has subsequently issued amendments, including updates dated September 1, 2025 and April 30, 2026. Companies should therefore refer to the latest version of the Code when preparing their compliance and disclosure documents.
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What Is UCMPMD?
UCMPMD stands for Uniform Code for Marketing Practices in Medical Devices.
The Department of Pharmaceuticals introduced UCMPMD to establish ethical standards for marketing medical devices and interactions between medical device companies and healthcare professionals.
The current UCMPMD 2024 framework addresses areas including:
- Medical device promotional activities
- Product claims and comparisons
- Promotional materials
- Medical representatives
- Evaluation samples
- Demonstration products
- CME, CPD, training and educational events
- Research support
- Interactions with healthcare professionals
- Marketing expenditure disclosure
- Complaint handling
- Appeals and corrective actions
The current Department of Pharmaceuticals portal identifies UCMPMD 2024 as the applicable code and provides the disclosure portal and related compliance information.
Is UCMPMD Mandatory for Medical Device Companies?
The Department of Pharmaceuticals’ current UCMPMD portal describes the UCMPMD 2024 as a mandatory code. Therefore, companies should not continue describing UCMPMD simply as a voluntary code in their compliance materials.
The Code also establishes an Ethics Committee for Marketing Practices in Medical Devices (ECMPMD) at the association level, with an appeal mechanism through the Apex Committee for Marketing Practices in Medical Devices.
Companies should therefore treat UCMPMD compliance as an ongoing governance responsibility rather than an optional marketing exercise.
Who Needs to Consider UCMPMD Compliance?
UCMPMD is relevant to medical device companies involved in activities covered by the Code, including companies involved in the promotion and marketing of medical devices.
This can include:
- Medical device manufacturers
- Importers
- Distributors
- Marketing companies
- Other entities involved in covered promotional activities
Companies should assess their specific activities against the latest Code rather than assuming that only manufacturers are covered.
What Is a UCMPMD Self-Declaration?
The self-declaration is a formal undertaking by the executive head of the company confirming compliance with UCMPMD.
The prescribed declaration confirms that the company has complied with the Code for the relevant financial year and undertakes to continue following its provisions and assist authorities in its implementation.
The self-declaration should be treated as part of the company’s compliance record and should be reviewed carefully before it is signed.
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Who Signs the Self-Declaration?
The UCMPMD framework places responsibility for adherence to the Code on the company’s Chief Executive Officer, with the prescribed disclosure submitted by the executive head of the company.
The declaration should therefore be coordinated between the relevant compliance, regulatory, finance and management teams.
When Should UCMPMD Compliance Be Filed?
The current Code provides a two-month period after the end of every financial year for the applicable disclosure.
For example, for a financial year ending March 31, the filing period extends for two months after the financial year closes.
Companies should not wait until the final days of the filing window. Marketing, finance and compliance teams should maintain the relevant information throughout the year.
Where Should the UCMPMD Disclosure Be Submitted?
The submission route depends on the company’s association membership.
If the company is a member of a medical device association
The company submits its disclosure through the applicable association.
If a company is a member of more than one association, the current Code provides a mechanism to select one association for the disclosure, subject to the applicable notification requirements. The company then continues with that association unless the conditions specified in the Code apply.
If the company is not a member of an association
The disclosure is made through the UCMPMD portal of the Department of Pharmaceuticals.
The Department of Pharmaceuticals currently provides an online portal for disclosure of marketing expenditure under UCPMP and UCMPMD.
What Is Marketing Expenditure Disclosure Under UCMPMD?
The prescribed UCMPMD disclosure form requires companies to report specified expenditure and activity information.
The form includes information relating to:
- Free evaluation samples
- Number of healthcare professionals receiving evaluation samples
- Education programmes organized directly by the company
- Education programmes organized through third parties
- Expenditure incurred
- Number of events
- Event locations
- Methodology used to calculate expenditure
Education programmes can include CME, CPD, conferences, workshops, trainings and seminars.
The disclosure form also requires company information such as CIN or FCRN, company name, registered address, email, PAN and financial year information.
What Expenses Are Included?
The current disclosure form states that expenditure for covered events includes expenses such as:
- Sponsorship
- Travel
- Lodging
- Hospitality
- Advertisements
- Exhibition stalls
- Souvenirs
- Payments made directly to third-party vendors
The applicable valuation methodology should also be followed when calculating the value of relevant products or expenditure.
This means companies should not limit their internal review to obvious advertising invoices. Finance and marketing teams should assess the complete expenditure associated with covered activities.
How Operon Strategist Can Help
Operon Strategist provides medical device regulatory consulting services to help companies understand and manage regulatory and compliance requirements in India.
Our support can include:
- UCMPMD compliance assessment
- Self-declaration preparation support
- Marketing expenditure disclosure support
- Regulatory documentation review
- Medical device regulatory compliance
- Promotional material compliance review
- Regulatory strategy
- CDSCO regulatory consulting
- Compliance process development
For medical device companies managing multiple products, distributors, marketing teams and HCP activities, establishing an internal compliance process can help reduce the risk of inconsistent disclosures and unsupported promotional claims.
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FAQ
Is it mandatory to follow these guidelines?
No, they’re voluntary — but strongly recommended by government bodies and associations. Ignoring them can harm your business reputation.
Do travel and hospitality expenses fall under these guidelines?
No, they cover marketing and educational promotions like CME, CPD, and product demos.
What if a company submits incorrect information?
It can damage credibility and attract regulatory attention. Always stay accurate and transparent.
Who is responsible for filing the disclosures?
The company’s CEO, MD, or an authorized official must file the annual declaration and expenditure disclosure.