If anyone is facing health problems with their head or neck, then they will be get recommended to an Otolaryngologist and your neck & head issues are diagnosed, treated, and managed by Otolaryngologist. Diagnosis & treatment of both children & adults with diseases & orders of the Ear, Nose, and Throat (ENT), which comprises sinuses, oral cavity, larynx (voice box) & upper pharynx (throat & mouth) and related structures of the neck & head is also called Otolaryngology. If anyone is planning an ENT speciality hospital with both OT & OPD set up, you will need all devices required for examining the Ear, Nose & Throat. But, before using ENT medical devices in India, it is mandatory for all the manufacturers of ENT medical devices to get CDSCO Registration for ENT Medical Devices in India. In this write-up, we will discuss how to apply for CDSCO Registration for ENT Medical Devices in India.
An Overview of the Market of ENT Medical Devices
During the forecast period of 2021-2031, the international ENT Medical Devices market is gaining traction & likely to ascend to around 5.5% CAGR. A rise in health awareness coupled with an increase in demand from the geriatric population has been increasing the sales of ENT Medical Devices for the past decade, while the adoption of advanced technologies is further augmenting demand growth for Ear, Nose & Throat Medical Device suppliers.
As per the latest report, technological advancements & recovery of medical devices & diagnostic sectors from the Covid-19 pandemic will be key for industry players to excel in this sector over the coming years.
Different Classes of Medical Devices in India
Provisions related to the manufacture, sale, import, and distribution of medical devices are regulated & governed under the provisions of the Drug & Cosmetics Act, 1945. Under the new Medical Device Rules, 2017, all medical devices have been classified into 4 categories depending on their risk & usability involved, as provided below:
- Class-A: Low-risk devices.
- Class-B: Low Moderate Risk.
- Class-C: Moderate high-risk devices.
- Class D: High-risk devices.
Class A and B Medical Devices are considered to be less-risky & moderate medical devices for which the application to manufacture must be filed to the SLA or State Licensing Authority. Whereas Class C & Class D are considered to be high & very high-risk devices & the application for these has to be filed to the CLA (Central Licensing Authority) of India.
Classification of ENT Medical Devices
The ENT or Ear, Nose & Throat category consists of a total of 69 Medical Devices, which are highly categorised on the basis of their risk class. Out of which, only Class A & Class B Medical Devices will come under the Licensing Regime from 1st Oct 2022.
|ENT Medical Devices|
|Medical Device Name||Class|
|Anchored Bone-Conduction hearing implant system||C|
|Audiometer testing system||A|
|Auditory evoked-potential graphic recorder|
|Behind-the-ear air-conduction hearing aid||B|
|Behind-the-ear air-conduction tinnitus masker||B|
|Behind-the-earbone-conduction tinnitus masker||C|
|Cochlear implant assessment system||C|
|Ear canal impression tray||A|
|Ear canal light||A|
|ENT chair, electric||B|
|ENT chair, mechanical||B|
|ENT Shaver System||B|
|ENT surgical microscope||B|
|Flexible fibre optic nasopharyngolaryngoscope||B|
|Flexible fibre optic rhinoscope||B|
|Flexible fibre optic sinoscope||B|
|Flexible video antroscope||B|
|Nasal Septum straightening forceps||A|
|ENT Nasal snare||B|
|Ossicular prosthesis, partial||C|
|Middle ear mold||C|
|Fully-implantable middle ear implant system||C|
|Ossicular prosthesis, total||C|
|Soft-tissue surgical forceps alligator||B|
|Eustachian tube balloon dilation system||B|
|ENT electric or pneumatic surgical drill||C|
|Argon laser for rhinology, otology & laryngology||C|
|Ear, Nose & Throat microsurgical carbon dioxide laser||C|
|Esophagoscope (rigid or flexible)||B|
|Mediastinoscope & accessories||B|
|Bone particle collector||A|
|Suction antichoke device||C|
|Tongs antichoke device||C|
|Powered nasal irrigator||B|
|External nasal splint||A|
|External upper esophageal Sphincter compression device||C|
|Wireless air conduction hearing aid||B|
|Hearing aid calibrator & analysis system||B|
|Tympanic membrane contact hearing aid||D|
|Master hearing aid||B|
|Active implantable bone conduction hearing system||C|
|Battery-powered artificial larynx||B|
|Partial ossicular replacement prosthesis||C|
|Total ossicular replacement prosthesis||C|
|Mandibular implant facial prosthesis||C|
|Sacculotomy tack (Cody tack)||C|
|Tympanostomy tube with semipermeable membrane||C|
|Transcutaneous air conduction hearing aid system||C|
|Acoustic chamber for audiometric testing||A|
|ENT cupped forceps||A|
Documents Required for CDSCO Registration for ENT Medical Devices
Following is the list of documents required for CDSCO Registration for ENT Medical Devices:
- Duly filled application form;
- Plant Master Report;
- Device Master File;
- Either a FSC (Free Sale Certificate)/Certificate from the Foreign Government;
- Full Quality Assurance Certificate;
- ISO 13485 Certificate;
- CE Design Certificate;
- Undertaking that all details provided is authentic.
Also, the manufacturer needs to submit the following details under the Device Master File & Plant Master Report of the Medical Device:
- Details regarding the name, qualifications & experience of the technical staff involved in manufacturing the medical device.
- Qualitative & quantitative specifications of the device;
- Labelling details as per the Drugs & Cosmetics Act, 1940;
- Details of the facilities to conduct various tests in the manufacturing premises;
- Details as to names & addresses of the Company’s Directors, the manufacturing address and the registered office address;
- Brand name under which the ENT medical device is to be manufactured;
- The device category belongs to & a detailed description of the medical device along with the intended usage, the methods of such usage & specific storage conditions of the medical device;
- Details regarding variation in the size and shape of the medical device along with the specifications of the material used;
- A detailed explanation of the manufacturing process;
- Details of any warnings, precautions & adverse effects to be taken while using the medical device & a summary indication of any problem or issue which has been earlier reported;
- Details of the facilities to conduct various tests in the manufacturing units or premises.
Step-by-Step Procedure for CDSCO Registration for ENT Medical Devices
Following are the 4 steps involved in CDSCO Registration for ENT Medical Devices:
Step 1: Determine whether your Medical Device is under notified list or not: The CDSCO has provided a detailed list of notified medical devices that need to mandatorily obtain Registration under the Drugs & Cosmetics Act, 1940 & in accordance with MDR, 2017. However, there may be any medical devices that haven’t been notified by the concerned Authority/in the case of a new medical device, the importer or manufacturer shall be required to obtain a No Objection Certificate (NOC) in such instances.
Step 2: Appoint an AIR (in case of a Foreign Entity): For a Foreign Business Manufacturer or entity, it shall be important to appoint an authorised business representative in India who shall be the contact person or individual for the inspection authorities during the process, help in approvals, registrations process & vigilance adverse event reporting. The Indian Authorisation should also hold a Wholesale Drug License in Forms 20B & 21B.
Step 3: Filing Application: In this important step, the manufacturer or importer of Medical Devices must submit the Registration form for CDSCO Registration for ENT Medical Devices along with the required documents and prescribed fee on the official website of CDSCO to the Drugs Controller General of India.
Step 4: Get a Registration Certificate: Once the application for CDSCO Registration for ENT Medical Devices is submitted, the Authority may send a query or question through an inquiry letter to the manufacturer/from the Authorised Indian Representative of the importer along with the given timeline within which the query should be answered. On satisfaction, the CDSCO Authority may issue a License and after obtaining a Certificate for CDSCO Registration for ENT Medical Devices, the Manufacturer or his Authorised Representative may apply for an Importer License.
Note: Once obtain the CDSCO Registration for ENT Medical Devices shall be valid for 3 years only from the issuance date of the Registration Certificate unless cancelled/suspended by the Authority for proposer causes
Renewal of CDSCO Registration for ENT Medical Devices
The application for the Renewal of CDSCO Registration for ENT Medical Devices shall be made at least 9 months before the expiry of the Registration Certificate. Though there are no extra requirements for the Renewal, it shall be vital for the Certificate Holder to provide Device Master File & Plant Master File.
CDSCO mandatorily requires that ENT Medical Devices, which are in the notified list regulated by CDSCO, must be registered as per the Drugs & Cosmetics Act, 1940 & MDR, 2017, for such devices to be deployed freely in the Indian Market. Importers & Manufacturers looking to manufacture, sell, distribute, export, or import such devices in the Indian Market should be aware of the process & legal and regulatory compliance involved & get the requisite License from the SLA.