The Union health ministry has exempted State and Central Government testing labs from National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation for two years under new Medical Devices (MD) Rules 2017 through a notification dated October 16, 2019.
The notification was made after consultation with the Drugs Technical Advisory Board (DTAB) which recommended to come out with the Medical Devices (Fifth Amendment) Rules, 2019 by amending MD Rules, 2017.
As per the notification, the following provision shall be inserted in the MD Rules, 2017, in rule 19, namely- “Provided further that the testing laboratories of State Governments and Central Government shall be exempted from the requirement of the accreditation by the National Accreditation Board for Testing and Calibration Laboratories for a period of two years from the date of coming into force of the Medical Devices (Fifth Amendment) Rules, 2019.”
The MD Rules, 2017 was published in the official gazette dated January 31, 2017 and last amended through notification dated September 13, 2019.
The Union health ministry through a notification dated February4, 2019 invited objections and suggestions from all stakeholders before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public on February 5, 2019.
The Central Drugs Standard Control Organisation (CDSCO) has notified four medical devices testing laboratories (MDTL) for carrying out evaluation of medical devices under the new medical devices rules 2017 on behalf of manufacturers in the country.
In the meantime, the Union health ministry is also planning to upgrade manpower at CDSCO towards effective licensing and enforcement activities to ensure safety, quality and performance of medical devices.
As per the road map outlined till 2020, the ministry has set out to upgrade CDSCO manpower by creating additional 1,195 new posts, including 64 experts, and additional 4,300 personnel for new laboratories, mobile drug testing labs, e-governance and training.
As per the recent DTAB recommendation, five laboratories should be set up within a span of five years for testing of various medical devices and in-vitro diagnostics (IVDs) medical device.