Demand for imported medical devices has fuelled in recent years primarily due to increasing healthcare expenditure, rising prevalence of chronic diseases, expanding insurance coverage, and growing awareness about advanced medical technologies. The volume and value are substantial in respect of high-end diagnostic equipment, surgical instruments, implantable devices, and advanced monitoring systems. Importing medical devices is a multi-regulatory process involving customs law, foreign trade policy, drug regulation, quality standards, and GST.
In this article, let us explore the regulatory perspective of importing medical devices into India.
1. Regulatory Framework: Who Governs Medical Device Imports?
Medical device imports are controlled through five parallel legal tracks:
- Customs Act, 1962 – Clearance, valuation, classification, enforcement
- Foreign Trade Policy & DGFT – Import policy (Free/Restricted)
- Drugs & Cosmetics Act and MDR, 2017 – CDSCO licensing
- BIS Standards – Product conformity where notified
- GST Law – IGST on imports and ITC
A compliant import must satisfy all five.
2. What Is a “Medical Device” in Law?
Under Medical Devices Rules, 2017, a product becomes a medical device if:
- It is intended for diagnosis, prevention, monitoring, treatment, or alleviation of disease, or
- It is notified by the Government as a medical device
3. Risk-based classification:
India now follows risk-based classification of medical devices based on intended use, duration of contact with the body, invasiveness, and potential risks.
- Class A: Low Risk include non-invasive devices such as examination gloves, hospital furniture, and simple diagnostic instruments. They require simple registration.
- Class B devices include slightly more complex items such as syringes, blood bags, and simple monitoring equipment.
- Class C devices encompass products like orthopedic implants, certain surgical instruments, and advanced diagnostic equipment.
- Class D devices, representing the highest risk category, include items such as cardiac stents, heart valves, implantable pacemakers, and other life-supporting or life-sustaining devices.
Thus, the classification determines the level of regulatory scrutiny.
4. CDSCO Registration: The First Gate
The Central Drugs Standard Control Organization (CDSCO), operating under the Directorate General of Health Services in the Ministry of Health and Family Welfare, serves as the primary regulatory authority for medical devices.
Before import, the importer must:
- Register on the CDSCO portal
- Obtain:
- Import licence for notified medical devices
- Registration of foreign manufacturer and product
Documents typically include:
- Free Sale Certificate from country of origin
- Plant Master File and Device Master File
- Quality certifications (ISO 13485, etc.)
- Undertaking and authorizations
Import without CDSCO licence is treated as prohibited import, even if the item is “Free” under DGFT policy.
5. Import Policy Under DGFT
Most medical devices are:
- “Free” under ITC(HS), but
- Subject to regulatory compliance conditions
Some categories may still be:
- Restricted
- Subject to special conditions or notifications
DGFT does not replace CDSCO. It only controls policy permission, not product safety.
6. Role of BIS in Medical Device Imports
BIS compliance applies where:
- The product falls under a notified Indian Standard
- Compulsory Registration Scheme (CRS) or ISI marking is prescribed
For certain electronics-based medical devices, BIS compliance may apply in parallel with CDSCO.
A product may be cleared by CDSCO but still detained by Customs for missing BIS registration.
7. Customs Clearance: Where Most Problems Start
At the port, Customs will verify:
- CDSCO import licence
- Product and manufacturer registration
- DGFT compliance
- BIS registration (if applicable)
- Valuation and classification
- Country of origin
Common triggers for detention:
- Import before licence date
- Mismatch between invoice description and CDSCO registration
- Wrong HS classification
- Missing BIS compliance
- Related-party valuation disputes
Customs can:
- Detain goods
- Order testing
- Initiate confiscation proceedings
8. GST on Import of Medical Devices
On import, the importer pays:
- Basic Customs Duty
- Social Welfare Surcharge
- IGST
Key issues in practice:
- Wrong classification leading to wrong GST rate
- ITC denial due to documentation gaps
- Disputes where customs reclassify the product post-clearance
IGST paid on import is generally eligible as input tax credit, subject to GST conditions.
9. Common Mistakes Importers Make
- Importing samples without CDSCO clearance
- Treating “Free” import policy as unrestricted
- Ignoring BIS applicability
- Importing before licence is granted
- Depending entirely on customs brokers
- Not aligning product description across all documents
Final Thought
The growing market, increasing healthcare infrastructure, and rising demand for advanced medical technologies create compelling business prospects. However, success requires meticulous attention to regulatory compliance, quality assurance, and strategic market positioning.
In case of any query and clarification regarding imports compliance, advisory and litigation and require any support, you may like to connect with us.
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Abhinarayan Mishra FCA, FCS, LL.B, IP, RV; Managing Partner, SAM Law Associates LLP; KPAM & Associates, Chartered Accountants, New Delhi ; +91 9910744992; ca.abhimishra@gmail.com; samlawassociates18@gmail.com
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