An Overview:
In a significant regulatory update, the Indian government has amended the Medical Devices Rules (MDR), officially classifying surgical and medical examination gloves as medical devices. The Ministry of Health and Family Welfare (MoHFW) has also designated 27 Medical Device Testing Officers (MDTOs) across six laboratories for enhanced regulatory oversight.
Key Amendments in the Notification
The Central Government, under sub-rule (2) of rule 19 of the Medical Devices Rules, 2017, amended its earlier notification (S.O. 2237(E), dated June 1, 2018). The following changes have been made:
- Inclusion in Medical Devices List:
- Serial No. (2): After “Condoms,” “Surgical Gloves and Medical Examination Gloves” have been added.
- Serial No. (3): After “disinfectant,” “Surgical Gloves and Medical Examination Gloves” have been inserted.
- Serial No. (5): After “and Falope Rings,” “Surgical Gloves, Medical Examination Gloves, Cotton Bandages, Anticoagulant Solutions used in Blood Bags, and Disposable Syringes” have been added.
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Testing Laboratories Designated
The following Central Drugs Testing Laboratories (CDTL) have been authorized for testing surgical and examination gloves:
- CDTL Chennai
- CDTL Kolkata
- CDTL Mumbai
Additionally, 27 Government Analysts have been designated as MDTOs for various medical devices, ensuring rigorous testing and compliance.
Why This Matters
The classification of gloves as medical devices strengthens quality control, ensuring better compliance and safety standards for healthcare products.
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