DOWNLOAD LATEST NOTIFICATIONS, GUIDELINES, RULES AND STANDARDS
- Classification of Anesthesiology Products
- Classification of Cardiovascular Products
- Classification of Dental Products
- Classification of Dermatological and Plastic Surgery Products
- Classification of ENT Products
- Classification of Gastroenterology Products
- Classification of General Hospital Products
- Classification of Interventional Radiology Products
- Classification of Medical Devices and In-Vitro Diagnostic Device Products
- Classification of Nephrology Products
- Classification of Neurological Products
- Classification of Obstetrical and Gynecology Products
- Classification of Oncology Products
- Classification of Operation Theatre Products
- Classification of Ophthalmology Products
- Classification of Pain Management Products
- Classification of Pediatrics and Neonatology Products
- Classification of Personal Protective Equipment Products
- Classification of Physical Support Products
- Classification of Radiotherapy Products
- Classification of Rehabilitation Products
- Classification of Respiratory Products
- Classification of Software Products
- Classification of Surgical Instruments for General Use Products
- Classification of Urology Products
- Exemption of Class A (Non-sterile and Non-Measuring) Medical Devices from Licensing Regime
- Notification for Implementation of Medical Device Wholesale License MD 42
- Notification for Voluntary Registration of Medical Devices
- Notification of all Class A and B Devices under the Licensing Regime from October 1, 2022
- Notification of all Class C and D Devices under the Licensing Regime from October 1, 2022
- National Single Window System NSWS January 1, 2024
ACTS, RULES, FORMS & GUIDELINES
Access the Latest Acts and Rules Governing Medical Devices for Regulatory Compliance
- Medical Device Rules, 2017
- Medical Devices (Fifth Amendment) Rules, 2022
- Medical Devices (Sixth Amendment) Rules, 2022
- Medical Devices (Amendment) Rules, 2020
- Application for Registration Certificate for Sale of Medical Devices-Form MD 41
- Registration Certificate to Sale and Distribute Medical Devices-Form MD 42
- Application for Grant of Manufacturing License of Class A or Class B Medical Devices-Form MD 3
- License to Manufacture Class A or Class B Devices-Form MD 5
- Application for Grant of Manufacturing License of Class C or Class D Medical Devices-Form MD 7
- License to Manufacture Class C or Class D Devices-Form MD 9
- Application for Licence to Manufacture Medical Device for purpose of Clinical Investigations, Test, Evaluation, Examination, Demonstration or Training-Form MD 12
- Licence to Manufacture Medical Device for purpose of Clinical Investigations, Test, Evaluation, Examination, Demonstration or Training-Form MD 13
- Cosmetics Rules, 2020
Let’s Get Started on Your Medical Device Licensing Journey