Govt panel starts drafting rules for refurbished medical device imports

A high-level inter-departmental committee has begun discussions on regulating refurbished medical devices, balancing patient safety concerns with affordable healthcare access

A central government’s inter-departmental high-level committee has begun discussions on framing new rules to regulate the entry of refurbished or second-hand medical devices into India.

 

Valued at ₹1,500 crore, the pre-owned medical equipment market currently accounts for nearly 10 per cent of the overall medical equipment industry in the country, according to industry executives.

 

People familiar with the matter told Business Standard that while only a couple of meetings have been held so far, the committee has started reviewing data related to the refurbished devices market. Officials confirmed that the panel includes representatives from the Ministry of Health and Family Welfare (MoHFW), the Directorate General of Health Services (DGHS), the Central Drugs Standard Control Organisation (CDSCO), the Department of Pharmaceuticals, and industry stakeholders.

   

The move follows a letter from CDSCO to the principal commissioner of Customs dated January 10, in which the regulator acknowledged that the Medical Devices Rules (MDR), 2017, do not specify regulations for refurbished devices.

 

“MDR 2017 has a provision for import of medical devices and the requirements are well set for this. The regulation does not differentiate between new and refurbished medical devices,” sources in the health ministry said.

 

Currently, such imports are allowed through no-objection certificates from an expert committee of the Ministry of Environment, Forest and Climate Change (MoEFCC), which can approve applications to bring in 38 high-end and high-value (HEHV) medical equipment strictly based on a list prescribed by the DGHS.

 

The imports are subject to conditions, such as allowing HEHV equipment that has not been phased out from the importing country must not contain any hazardous materials and has a residual life of seven years.

 

“Major issues to be discussed by the committee may include determining the service time of second-hand devices eligible for import or allowing only very expensive, high-end critical care equipment used for critical care,” an official said.

 

Sources in the MoEFCC said that while there are no existing provisions for refurbished equipment under the MDR, the health ministry is creating regulatory mechanisms to facilitate the ease of doing business in this area.

 

“While the health ministry is amending provisions in the MDR, we have not been directly involved in policy formulation. However, MoHFW has shared a draft or proposal with MoEFCC for comments,” the person added.

 

The official said the health ministry would finalise a comprehensive policy on this matter in due course, as all such decisions ultimately lie within its purview.

 

Pre-owned medical devices include robotic-assisted surgery (RAS) systems, linear accelerators (LINACs), and CT scanners. “These play a critical role in meeting the growing demand in Tier-II, -III, and -IV cities, as well as rural and underserved areas,” an industry executive said.

 

While some companies claim that refurbished devices provide affordable solutions for health care providers in smaller cities, several domestic manufacturers and lobby groups have earlier urged the government to curb the unregulated inflow of high-risk second-hand equipment, citing patient safety concerns.

 

The Patient Safety and Access Initiative of India Foundation, a Delhi-based not-for-profit organisation, has filed a public interest litigation in the Delhi High Court, highlighting concerns related to the reliability of devices and their potential risks to patient safety.

 

Medtech bodies wants second-hand devices included in ERSO

 

Seven months after Indian regulators conveyed that there are no specific regulations to allow imports of refurbished medical devices, medtech industry bodies have called for inclusion of such devices under the government’s Electronics Repair Services Outsourcing (ERSO) pilot initiative to further advance their repair operations.

 

The ERSO, an initiative of the Ministry of Electronics and IT, aims to establish India as a global hub for electronics repair services.

 

To guarantee quality and patient safety of such devices, Medical Technology Association of India (MTaI), a representative body for multinational corporations in medtech sector, recommended limiting refurbishment of medical devices to original equipment manufacturers (OEMs). “This ensures devices are updated by experts with genuine spares that meet strict regulatory standards,” it said.

 

MTaI also said the suspension of refurbished medical device imports could hamper health care services, especially in Tier-II to IV cities and rural areas. However, sources in the health ministry said that drug regulator CDSCO has not issued any public order to ban import of refurbished medical devices, with status quo being maintained for such imports.