Pain Management is a branch of medical science which eases the suffering of patients who suffer from chronic pain. Acute pain has a sudden onset of action, whereas chronic pain persists for a longer duration, which leads to the need for its management. So, Pain Management Medical Devices are used in the management of various types of pain, such as cancer pain, musculoskeletal pain, nociceptive pain, and others. In 2020, the global Pain Management Devices market was valued at $3,689.20 million and was projected to reach $5,767.69 million by 2028, registering a CAGR of 6.3% from 2021 to 2028. So, for all the importers and manufacturers of Pain Management Medical Devices, it is compulsory to get CDSCO Registration for Pain Management Medical Devices to sell their products in Indian Market.
Classification of Medical Devices in India
The CDSCO classifications of Medical Devices in India govern alongside the Regulatory Approval & Registration by the CDSCO under the DCGI. Every single Medical Device in India pursues a Regulatory Framework that depends on the Drug Guidelines under the Drugs & Cosmetics Act, 1941 and Drugs & Cosmetics, 1945. The Classification of Medical Devices has a set of risk classifications for numerous products planned for notification & guidelines as Medical Devices.
Generally, Medical Devices in India are based on risk and depend upon their intended use & purpose. CDSCO Classification for Medical Devices has a larger group of devices.
|Class A||Low-Risk||Absorbent cotton wools, alcohol swabs, etc.|
|Class B||Low-Moderate Risk||BP Monitoring Device, Thermometer, etc.|
|Class C||Moderate High-Risk||Implants, Haemodialysis Catheter, etc.|
|Class D||High-Risk||Heart Valve, Angiographic Guide Wire, etc.|
Classification of Medical Devices Regarding Pain Management
Recently, CDSCO issued a notification stated from 1st October 2022; the said Medical Devices having Class A and B will be covered under the Licensing Regime of CDSCO. Once all devices are under the scope of Licensing Regime of CDSCO, all the manufacturers and importers of the said devices will have to apply for the License to sell their products in Indian Market.
The category of Pain Management consists of a total of 69 Medical Devices, which are categorised on the basis of their risk class & intended use. Out of which, only Class A & B Medical Devices will come under the Licensing Regime from 1st October 2022. You can check the table of the Classification of Medical Devices Pertaining to Pain Management below:
|Medical Device Name||Class|
|Acupressure Calf Band||A|
|Acupuncture Electrical Stimulation System||B|
|Acupuncture Point Detector||B|
|Analgesic PENS System||B|
|Analgesic TENS system||B|
|Arthritis TENS System||B|
|Arthritis Transcutaneous Electrical Joint Stimulation System||B|
|Bed or Chair Electric Massager||B|
|Bite Relief Pad||A|
|Blue or Red or Infrared Phototherapy Lamp||B|
|Circulating-Fluid Thermal Therapy System||B|
|Cold-Air Therapy Unit||B|
|Deep-Tissue Electromagnetic Stimulation System||B|
|Ear Microsystem Needle||A|
|Electric Pad Localised-body heating system||B|
|Endothermic cold therapy pack||B|
|Exothermic heat therapy pack||B|
|Heat Therapy Gel||B|
|Hydrotherapy Bath or Tank||B|
|Inflatable hot or cold therapy pack or electric pump||B|
|Inhalational Analgesia Unit||B|
|Interferential Electrical Stimulation System||B|
|Intervertebral Disc Prolapse Therapy Pack||B|
|Intubation Teeth Protector||A|
|Massage Table or Couch||A|
|Musculoskeletal Infrared Phototherapy Unit||B|
|Pain-Relief Phototherapy Skin Patch||A|
|Pain-Relief Static Magnet||A|
|Physical Therapy Paraffin Wax Bath||B|
|Short-Wave Diathermy Treatment System||B|
|Sitz Bath Chair||A|
|Static Magnetic Back or Spine Insulator||B|
|Static Magnetic Bed Mattress Overlay||A|
|Static Magnetic Bracelet||A|
|Static Magnetic Elbow Orthosis||B|
|Static Magnetic Foot Arch Orthosis||B|
|Static Magnetic Joint Insulator||B|
|Static Magnetic Knee Orthosis||B|
|Static Magnetic Lumbar Spine Orthosis||B|
|Static Magnetic Massager||A|
|Static Magnetic Shoulder Orthosis||B|
|Static Magnetic Thoracic pine Orthosis||B|
|Traction System Belt||A|
|Wearable Cervical Spine Traction Device||B|
|Wearable Lumbar Spine Traction Device||B|
Documents Required for CDSCO Registration for Pain Management Medical Devices
Following is the list of crucial documents required for CDSCO Registration for Pain Management Medical Devices:
- Duly-filed Application Form;
- ISO 13485 Certificate;
- Full Quality Assurance Certificate;
- Plant Master Report;
- Device Master File;
- Either an FSC (Free Sale Certificate) or Certificate from the Foreign Government;
- CE Design Certificate;
- Marketability Certificate from GHTF;
- Undertaking that all information provided is authentic.
Procedure for CDSCO Registration for Pain Management Medical Devices
Following is the step-by-step procedure for CDSCO Registration for Pain Management Medical Devices:
Step 1: Find Whether Your Product Comes under Notified List or Not: The CDSCO or the Central Drugs Standard Control Organisation has formulated a list of notified medical devices based on risk-level categorisation that needs CDSCO Registration under the Drugs & Cosmetics Act, 1940 and as per the Medical Devices Rules, 2017. However, there may be any Devices that haven’t been expressly notified by the concerned Authority, or in the case of new Medical Equipment, the Manufacturer or Importer shall be required to get NOC in such cases.
Step 2: Appoint an Authorised Representative (In case of Foreign Manufacturer or Entity): For a Foreign Business Manufacturer or Entity, it is necessary to appoint an Authorised Representative, who shall be the contact person for the Inspection Authorities at the time of Registration process, help in device approvals, vigilance adverse event reporting. Such Authorised Representative must have a Wholesale Drug License in Form 20B and 21B.
Step 3: Filing Application: In this step, the applicant, i.e., Manufacturer or Importer or Authorised Representative, must fill out the application form online for CDSCO Registration for Pain Management Medical Devices. While applying online, the applicant should upload all the vital documents in the prescribed format. Once completed, the applicant needs to pay the required fee.
Step 4: Obtain License: After submission of the application, documents, and fees, the Authority may send an inquiry letter enclosing the list of questions or queries to the applicant. The applicant must reply to all the queries or questions within the prescribed time limit. In some instances, the applicant may have to undergo a Technical Presentation on the direction of the Authority. After fulfilling all the requirements, the Authority will issue the License.
Validity of CDSCO Registration for Pain Management Medical Devices
Once the Certificate for CDSCO Registration for Pain Management Medical Devices is obtained, then it is valid for 3 years from the date of issue of Registration unless cancelled or suspended by the Authority for proper causes.
Renewal of CDSCO Registration for Pain Management Medical Devices
The application for the Renewal of the CDSCO Registration for Pain Management Medical Devices shall be made at least 9 months from the expiry of the Registration certificate. Though there are no additional requirements for the Renewal, it shall be mandatory for the Certificate holder to provide a copy of the Plant Master File & Device Master File, where there are no changes in the Plant Master File & Device Master File.
There are not many compliances in place regarding the Registration Certificate, but it shall be mandatory for the Certificate holder to:
- In case of any change that has taken place regarding the Constitution of the Firm and/or address of the Registered Factory or Office Premises, then the Medical Device Manufacturer or Authorised Representative of the importer to intimate the Licensing Authority regarding the same in writing;
- In case of any such change has taken place, the existing Registration Certificate shall be valid for 3 months from the date on which the change has taken place, and at this time, the Authorised Representative or the Manufacturer shall be required to get New Registration Certificate.
It is clear from the above that approval from CDSCO is mandatory for applicants or manufacturers seeking to engage with the manufacturing or import of drugs & medical devices. CDSCO Registration for Pain Management Medical Devices is the only legal way to start a business.