Do you know? Out of 5000 types of medical devices marketed in India, only 23 types are currently regulated by the Central Drugs Standards Control Organization (CDSCO). To increase the ambit of Regulatory supervision and ensure efficacy and safety of medical devices, in early 2017, the CDSCO drafted and published the Medical Device Rules – 2017, which were made mandatory from January 1, 2018.
Keeping with the requirements of the new rules, the agency has been continuously listing device types that will be regulated. These devices are required to be registered with the local health authority and all the foreign device manufacturers for similar device types must obtain an import license to import and market in the country.
Adding to the list, the CDSCO has recognized and included eight more device types on February 8, 2019. The newly added devices are:
- All implantable medical devices
- CT scan equipment
- MRI equipment
- Dialysis machine
- PET equipment
- X-Ray machine
- Bone marrow cell separator
The devices listed above have been published in a notification by the Ministry of Health and Family Welfare (MHHFW) in the Gazette of India. The rule will become a mandate with effect from April 1, 2020. In addition, previously, the CDSCO has also added four other devices to the list and mandated the manufacturers to register them as per before January 1, 2020.
Isn’t it making the year 2020 crucial for medical device manufacturers importing and marketing their devices in India? Of course, yes!
With the deadline inching closer, have you evaluated your device comparing it with the list of devices to be regulated? If not, you may have to begin the preparations by decoding the guidelines. Start now to meet the target dates. Be informed. Be compliant.