The Indian medical device sector is witnessing significant growth, driven by increasing healthcare demands, government initiatives like the Production Linked Incentive (PLI) scheme, and a heightened focus on domestic manufacturing. However, this growth comes with a complex and evolving regulatory landscape, particularly for companies operating in the Delhi NCR region — a major hub for medical technology and innovation. Understanding and obtaining the necessary approvals is critical for ensuring business continuity, legal compliance, and access to markets.
Key Regulatory Approvals for Medical Device Companies
1. CDSCO Registration (Medical Device Rules, 2017):
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR), 2017. Devices are categorized into Class A, B, C, and D based on risk levels. Manufacturers, importers, and distributors must obtain a CDSCO license or registration depending on the class of the device. For example, Class A and B require state-level approvals, while Class C and D need central-level licensing from the CDSCO.
2. Medical Device Manufacturing License:
Manufacturers operating in Delhi NCR must obtain a Form MD-5 license for Class A and B devices or a Form MD-9 license for Class C and D devices. The licensing process includes submitting technical documentation, plant inspection, and compliance with ISO 13485 standards for quality management systems.
3. Wholesale Drug License:
Distributors or traders dealing with medical devices often need a Wholesale Drug License (Form 20B and 21B), especially if the device falls under the definition of a drug. This license is issued by the State Drug Control Department and is mandatory for the sale and stock of regulated devices.
4. Import License:
If a company imports medical devices, it must obtain a Form MD-14 Import License from CDSCO, along with a Registration Certificate (Form MD-15) for the foreign manufacturing site. Regulatory submissions must align with the prescribed format and technical data requirements.
5. EPR Registration (if applicable):
For devices with electronic components or batteries, compliance under E-Waste (EPR) Rules and Battery Waste Management Rules is mandatory. Companies must register with the Central Pollution Control Board (CPCB) and submit annual EPR plans.
6. BIS Certification:
For certain diagnostic and electro-medical equipment, BIS (Bureau of Indian Standards) certification may be mandatory under the Compulsory Registration Scheme (CRS). This ensures conformity with prescribed Indian standards before such devices can be sold in the Indian market.
7. State Pollution Control Board NOCs (CTE & CTO):
Manufacturers in Delhi NCR also need Consent to Establish (CTE) and Consent to Operate (CTO) from the respective State Pollution Control Board (e.g., DPCC for Delhi, UPPCB for Uttar Pradesh) to ensure environmental compliance.
How Agile Regulatory Supports Medical Device Companies
Navigating the regulatory landscape in India can be challenging without the right support. Agile Regulatory, a trusted consultancy based in Delhi NCR, specializes in helping medical device companies obtain all essential licenses and approvals — from CDSCO registrations to pollution board NOCs and EPR certifications. With deep expertise in regulatory procedures, documentation, and compliance frameworks, Agile Regulatory ensures that companies can focus on innovation while meeting all legal requirements efficiently. Whether you're launching a new product or scaling manufacturing operations, their team of legal and technical experts provides end-to-end support tailored to your business.