Does Import or Manufacture of Dialysis Machine require any registration?

Which is the approving authority?

Why is the registration needed?

How to get the Dialysis Machine registered?

Yes, Dialysis Machine needs mandatory registration in India with effect from 1 April 2021.

Based on the proposal initiated by the Ministry of consumer affairs, food and public distribution, to the central licensing authority, Central Drugs Standard Control Organization (CDSCO), to include many devices under the ambit of the DCGI, Dialysis Machine finally need mandatory registration under the Medical Device Rules 2017 as well as other standards set by the Bureau of Indian Standard (BIS) certification from time to time.

As per, Notification number 648(E). Under the Medical Device Rules 2017,  It was clarified that the following types of devices will be considered as drugs from 1st April 2020.

“All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ” ― 

1. Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
2. Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
3. Investigation, replacement or modification or support of the anatomy or of a physiological process;
4. Supporting or sustaining life; 
5. Disinfection of medical devices; and 
6. Control of conception.

As notified, Dialysis Machine is a device used for acute or chronic kidney failure that filters blood to remove excess water and waste products.

Dialysis works on the principles of the diffusion of solutes and ultrafiltration of fluid across a semi-permeable membrane.

Types of Dialysis:

1. Hemodialysis: In hemodialysis, the patient’s blood is pumped through the blood compartment of a dialyzer, exposing it to a partially permeable membrane
2. Peritoneal dialysis: In peritoneal dialysis, a sterile solution containing glucose (called dialysate) is run through a tube into the peritoneal cavity, the abdominal body cavity around the intestine, where the peritoneal membrane acts as a partially permeable membrane.

Registration for Dialysis Machine under the above rules is mandatory with effect from 1st April 2021 under Class C of Medical Device Rules 2017.

Check the list of Devices

Which is the approving authority?

CDSCO , the Central Licensing authority is the approving authority for applications expected to be submitted to seek permission for manufacture or import Dialysis Machine.

Why is the registration needed?

Regulation was needed as there was a big spurt in mis-branded products, inferior quality, misdiagnosis and the results being reported through such devices were unacceptably inaccurate and were causing serious implications for people who rely on them. Rising healthcare expenditure and increasing healthcare awareness boost the concept of self-care management. Especially while the world is still coming to the impact of COVID 19 on the current and future “normal way” of work and self care, Dialysis Machine are a critically important category of product majorly due to its easy availability and ease of use by masses.

Regulatory Documents :

A comprehensive checklist of documents has been issued by the regulatory authority which needs to be submitted for processing and grant of relevant permissions.

Application Form	Approval Form	Risk/Class A,B,C,D	Fees	Licensing Authority
MD 14- Application for issue of import licence to import medical device In Class C or D  (Other than in vitro)	MD 15- Licence to Import Medical Device In Class C or D (other than in vitro)	C & D	$ 3000 for plant $ 1500 for product (per product)	CDSCO
MD 7- Application for Grant of License to Manufacture for Sale or for Distribution of Class C or Class D	MD 9- License to Manufacture for Sale or for Distribution of Class C or Class D	C & D	Rs-50000 for plant registration Rs-1000 for product (per product)	CDSCO
MD 8- Application for Grant of Loan License to Manufacture for Sale or for Distribution of Class C or Class D	MD 10- Loan License to Manufacture for Sale or for Distribution of Class C or Class D medical device	C & D	Rs-50000 for plant registration Rs-1000 for product (per product)	CDSCO

For a checklist of documents required for seeking grant of Import License in MD 15 , Please click here.

For a checklist of documents required for grant of License to manufacture for sale and distribution of Class C & Class D medical Device in MD 9, Please click here.

For a checklist of documents required for Grant of Loan License to Manufacture for Sale or for Distribution of Class C or Class D medical device MD 10, Please click here.

How can we help?

Preparing regulatory documents is a time consuming and meticulous exercise. As a local manufacturer, an importer or overseas manufacturer, one is already engrossed in various business aspects prior to placing the product in India. If a mistake is made, it can lead to unforeseen delays, regulatory gaps, business plan, overheads, financial planning issues  as well as supply chain disruption.

NKG has a Dedicated and Efficient team of experienced regulatory professionals who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by providing clear and easily understandable requirements.