Amendments Made In Medical Device Rules For NABL Accreditation

The medical device rules are the set of norms defined by the Ministry of Health and Welfare, GOI and amended from time to time. These rules govern the manufacture, import, sale and all other actions related to medical devices being sold across India.

These medical device regulations in India are amended from time to time to cope up with the latest trends, technology and market perspectives. In-line with these same procedures, a recent amendment was made to these rules related to the NABL accreditation of testing laboratories.

           

The new rules are called the Medical Device(Fifth Amendment) Rules, 2019 and have come into effect in October, 2019.

According to these new rules, a small provision has been added to the Medical Device Rules, 2017. Which states that the testing laboratories of the state government and central government shall be exempted from the requirement of accreditation by the National Accreditation Board for Testing and Calibration Laboratories(NABL) for a period of two years from the date of publication of this notification in the gazette.

What is NABL accreditation and why is it important?

NABL accreditation is a symbol of competence and trust. Just the ISO certification. If a laboratory is NABL accredited, it is a clear indication the it follows the best and standardized procedures with extreme care and precision. NABL accreditation is a globally recognized symbol of quality assurance. Hence being NABL accredited makes a lab look more reliable and credible.

Getting a NABL accreditation for a laboratory ensures that it can test and certify medical devices and drugs being recognized and used on a global scale, and not just in India. Moreover, it is an important step for certain globally scaling companies vying for medical equipment registration.

Why was this amendment made?

With the growing number of applications for testing of devices and drugs for medical device registration in India. The necessity of having an NABL certification can hinder the capability of state and central government laboratories to process such applications.

Obtaining NABL accreditation is a time-taking procedure and takes anywhere between six to eight months.