The Central Drugs Standard Control Organisation (CDSCO) has published the final risk classification list for Class A (non-sterile and non-measuring) medical devices under the Medical Devices Rules, 2017. This final list, contained in Appendix A, follows the publication of a draft list issued earlier this year and is now effective immediately. The classification confirms that these low-risk devices are exempted from most licensing requirements under the Rules, a measure intended to streamline regulatory compliance for manufacturers and importers of over 1,000 types of basic medical instruments and products.
Exemption and Registration Mandate
As stipulated by the notification dated October 14, 2022, all devices classified as Class A (non-sterile and non-measuring) are exempt from Chapters IV, V, VII, VIII, and XI of the Medical Devices Rules, 2017. However, this exemption is subject to a crucial compliance condition: the manufacturer or importer must obtain a registration number for such devices from the CDSCO Online System for Medical Devices, under the provisions of Chapter IIIB of the Rules.
Key Clarifications on Device Types
The notice provides three key points clarifying the boundaries of the Class A classification:
- Intended Use: The general intended use given in Appendix A is for guidance only. An applicant’s device may have a specific intended use, provided it is in similar lines to the general intended use mentioned in the CDSCO list.
- Exclusions: Any device that possesses a measuring function or is supplied in a sterile state cannot be considered a Class A (non-sterile and non-measuring) medical device under these rules.
- List Dynamics: The entire list of Class A devices is dynamic and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017.
Examples of Included Devices
The final list (Appendix A) enumerates over 1,000 devices, including a wide array of non-invasive and non-surgical items:
- General Instruments: Abdominal scissors (reusable), Acoustic Stethoscope, Forceps (dressing, utility), and reusable surgical probes.
- Support and Mobility: Abdominal support/belt/binders, Crutches, Wheelchair, and various orthopedic supports like Ankle/foot orthosis and Cervical spine collar.
- Dental and Ophthalmic: Dental impression trays, Dental spatulas, Fundus camera, Slit Lamp, and various forceps and instruments used for examination and transient procedures.
- Hospital Consumables/Equipment: Absorbent cotton wool, Adult Incontinence Pants/Diaper, Crash cart/Emergency recovery trolley, and Sterilization container.