MEDICAL DEVICES REGISTRATION SERVICES
Regulatory Requirements for Digital Thermometer
Does Import or Manufacture of Thermometers require any registration?
Yes, Digital Thermometers need mandatory registration with effect from 1st Jan 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, Digital thermometers 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 ―
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception.
As notified, Digital thermometer is a device used to record the body temperature.
Registration for Digital Thermometer under the above rules is mandatory with effect from 1st Jan 2021 under Class B of Medical Device Rules 2017.
Download Notification
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 Digital Thermometers.
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, thermometers are a critically important category of product majorly due to its easy availability and ease of use by masses. The mercury-free thermometer segment is estimated to dominate the overall market in terms of revenue and is expected to reach USD 1,119.0 million by 2025.
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 B (Other than in vitro) |
MD 15- Licence to Import Medical Device In Class B (other than in vitro) |
B |
$ 2000 for plant $ 1000 for product (per product) |
CDSCO |
|
MD 3- Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device |
MD 5- Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device. |
A & B |
Rs-5000 for plant registration Rs-500 for product (per product) |
SLA |
|
MD 4- Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device |
MD 6- Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device |
A & B |
Rs-5000 for plant registration Rs-500 for product (per product) |
SLA |
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 A & Class B medical Device in MD 5, please click here.
For a checklist of documents required for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device MD 6, please click here.
Preparing regulatory documents is a time consuming and meticulous exercise. As 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 complete delay in regulatory gaps, business plan, overheads, financial planning issues as well as supply chain disruption.
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NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now 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 following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
