Does Import or Manufacture of PET Equipment require any registration?

Which is the approving authority?

Why is the registration needed?

How to get the PET Equipment registered?

Yes, PET Equipment 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, PET Equipment 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, PET Equipment is a device used to detect the gamma radiation and positron emitting radionuclides in the body and produce cross-sectional images which reflect the distribution in the body or individual organs.

Positron emission tomography (PET) is an imaging technique that uses radioactive substances to visualize and measure metabolic processes in the body. PET is mainly used in the area of medical imaging for detecting or measuring changes in physiological activities like metabolism, blood flow, regional chemical composition, and absorption, and therefore, also called a functional imaging technique.

Uses:

1. Oncology
2. Neuroimaging
3. Cardiology
4. Infectious diseases
5. Bio-distribution studies
6. Small animal imaging
7. Musculo-skeletal imaging
   • Muscles
   • Bones

Registration for PET Equipment 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 PET Equipment.

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, PET Equipment 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 license to import medical device In Class C or D  (Other than in vitro)	MD 15- License 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 Licence 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.