Over the past year, India has enacted a series of significant regulatory reforms aimed at boosting the safety, quality, and transparency of its medical device sector. The new regulations and amendments, covering everything from risk-based quality control of imports to enhanced adverse event reporting and digitalized regulation procedures, reflect India’s commitment to align domestic practices with international norms while imposing greater accountability on manufacturers and importers.
Risk-Based Quality Monitoring and Categorization
The Indian government published a new risk-based strategy for the surveillance of imported medical devices’ quality in September 2024. The system aims to make regulation more efficient by varying the intensity of scrutiny according to the implied public health impact of each product.
Under the new system, most imported medical devices will be randomly sampled, except products of high priority, such as diagnostic kits, which will face stricter scrutiny. Entire shipments for some key public health products like vaccines, will be inspected to confirm they are safe and of good quality.
To facilitate the implementation, precise guidelines have been circulated among port officials explaining a three-step system of sampling: visual examination, field testing under the actual conditions of usage, and complete laboratory testing, as required. This program aims to enhance quality control without disproportionately delaying low-risk products.
In early 2025, the CDSCO released a draft list amending risk-based categorization for cardiovascular and neurological medical devices. The list contains 553 devices in all, 351 cardiovascular devices and 202 neurological devices, of which 221 are under Class D (highest risk), 153 under Class B, 151 under Class C, and 28 under Class A. This amendment is consistent with the Medical Device Rules (MDR) 2017 and the International Medical Device Regulators Forum (IMDRF) framework.
Introduction of a Uniform Code for Marketing Medical Devices
Around the same time, the Department of Pharmaceuticals also launched the Uniform Code for Marketing Practices in Medical Devices (UCMPMD), the first India-specific code to regulate the promotion and advertising of medical devices. Marketing practices of medical devices had previously been regulated indirectly under blanket laws like the Drugs and Cosmetics Act of 1940 and the Medical Device Rules of 2017.
The UCMPMD forbids marketing of medical devices before obtaining marketing approval and bribery of physicians or their relatives in relation to marketing efforts. Examples include extravagance at conferences, paid vacations, or cash payments. The Code also requires that industry groups establish ethics committees, which will report to the Department of Pharmaceuticals to ensure compliance.
Additional prohibitions are imposed on the use of product samples and stricter limits on marketing expenses. Firms have to post the UCMPMD on their websites and establish a mechanism for the public to file complaints.
More Rigorous Adverse Event Reporting
On November 4, 2024, the Drugs Controller General of India (DCGI) introduced revisions in the Materiovigilance Programme of India (MvPI), a national program for monitoring medical device adverse events that is operated by the Indian Pharmacopoeia Commission (IPC).
The new provision contains a revamped adverse event reporting form that is available to various stakeholders, ranging from manufacturers and importers to healthcare providers and patients. It contains greater detail of product information, including risk classification, importer/manufacturer license number, and date of manufacture, among other things, as well as a longer description of the adverse event and suggested corrective measures. Most importantly, the process ensures that the identities of patients and reporters remain confidential, which minimizes obstacles to reporting and fosters a culture of safety and openness.
In March 2025, the Health Ministry set up an expert committee under the MvPI to further intensify monitoring of adverse events. The committee, which will consist of experts in cardiology, neurology, and radiology, among other disciplines, will verify reports of the incidents and suggest safety measures. The move is India’s answer to getting its post-market surveillance closer to global standards and countering the risks of high-impact devices like implants and electronic medical devices.
Digitalization of Market Standing and Non-Conviction Certificates
The CDSCO also launched an entirely digitalized process for issuing the Market Standing Certificates (MSC) and the Non-Conviction Certificates (NCC). All applications dated April 9, 2025, onward must be submitted on the updated online portal; applications made using the old process are canceled automatically.
The MSC validates the regulatory status of a company, and the NCC validates that the company has no records of non-compliance in terms of safety and quality. The electronic transformation is intended to boost efficiency, transparency, and traceability of regulatory processing to the advantage of licensed manufacturers and importers.
A Year of Systematic Improvement
Overall, these initiatives in India indicate a trend towards a more structured, transparent, and standardized regulatory framework for medical devices in India. These regulatory controls cover many aspects of the product lifecycle, from pre-market authorization and marketing ethics to post-market surveillance.
We also see, in conjunction with the growth within medical device categories in India and expert panels being organized to review adverse events, a more proactive approach with emerging technologies and patient safety.
India’s medical device industry is currently undergoing a significant transition, with the last year seeing some of the most important regulatory changes in recent history. As the country pursues the dual objectives of supporting innovation and protecting public health, we should expect to witness continued focus on ethical behavior, quality assurance, and electronic regulatory processes.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.