“The new Medical Device Rules are still under transition period as Central Drugs and Standard Control Organization (CDSCO) pushes the new registration regime for another two years.”

Medical institutions are one of the essential parts of the country’s infrastructure, yet, the medical devices which are used to treat the patients do not fall under the mandatory certification but voluntary. Moreover, the market size of India’s health care sector was 194 billion US dollars in 2020 and as estimated, it would be 372 billion dollars in 2022.

Therefore, India has one of the largest healthcare markets, yet, the certification requirement for medical devices is voluntary. This imposes a great risk on individuals health, thus, giving rise to a question -

Is the government not prioritizing the medical devices certification?

And it is then why medical devices are not popular for certification under Bureau of Indian Standards and Quality Council of India (QCI).

CDSCO has postponed the mandatory registration of medical devices from september 30, 2021 to May 21, 2022 that has given a big push to the sale or distribution of inauthentic medical devices in the Indian market.

The new Medical Device Rules (MDR) - 2017 were supposed to implement the contemporary year, however, CDSCO’s postponement has increased the transition period for another two years i.e., October 1, 2021.

So, according to the notification of the government, it will take two more years to implement the MDR - 2017. Moreover, the earlier government had included 18 products for voluntary registration with the effect on April 1, 2020. Following the same, the medical devices under Class A and Class B will need a duration of 12 months for license processing, while products under Class C and Class D will require another 12 months.

In a nutshell, the complete process will be done by October, 2023 to implement the MDR.

Also, the Experts of the concerned fields hold a similar view in regard to product quality assurance of medical devices if their certification is not obligatory. Because it is to be noted that voluntary certification can only ensure reliable and high-quality products to a certain extent, once crossing the threshold, it is clear evidence that India’s market is flooded with unauthentic medical devices.

To mentioned the words of Former CEO, National Accreditation Board For Certification Bodies (NABCB) - Anil Jauhri, “Until the time regulations are not in place which will most likely come into being by October 2023, the manufacturers will show certificates most of which are unauthentic to impress the buyers who generally are ignorant. The risk of unauthentic certificates remains very high as medical devices are not yet regulated. Once a regulated and licensing regime is in place, there will be some quality assurance. In the absence of regulations, the buyers or customers will not be assured of any quality. Voluntary unauthentic, even fake, certificates will continue to rule the Indian market.”

The statement of Anil Jauhri clearly signifies the importance of mandatory certification for medical devices.

If diving into the notification deeply, according to the earlier notification issued by the Union Ministry on February 11, 2020, the medical devices have to undergo voluntary registration scheme from April 1, 2020 to September 30, 2021.

Thereafter, medical devices under Class A and Class B were subject for implementation of the mandatory scheme by April 1, 2020 to September 30, 2021. On the other hand, medical devices under Class C and Class D were subjected to mandatory registration September 20, 2023. Following the duration of the mandatory registration, these classes will result in transition to a licensing system.

Apart from just talking about limitations created due to voluntary certification schemes, Experts also have mentioned that many certificates under Quality Management System according to IS 13485 signifies the presence of unauthentic medical devices.

Now the question is, how could the quality management system be improved?

No doubt, a major step is required to tackle the limitations of the quality management system - one such solution could be accreditation of certification and inspection bodies by NABCB depending on competent assessment according to the applicable international standards and guidelines. These are the internationally recognized and represented standards which signifies the Indian industry interests at international forums through membership and active participation with the motive to become a signatory to international multilateral or mutual recognition arrangements (MLA or MRA).

Moreover, it is a member of International Accreditation Forum (IAF), International Laboratory Accreditation Cooperation (ILAC), Asia Pacific Accreditation Cooperation (APAC) and signatory to its MRAs for QMS and product certification.

So, below-mentioned is the list of NABCB-accredited certification bodies for ISO 13485 Medical Devices Quality Management Systems (MDQMS) -

Apart from accreditation the bodies, an authentic certificate must include information such as name and address of certified organization, scope of certification (indicating to the activities under certification), standards, and more according to which the certification has been issued.

Moreover, a certificate should also indicate the certification and expiry date, unique identification number of certificate, certification body’s logo, address, accreditation symbol, and more.

Above mentioned could be great pathways to provide safe and sound medical devices in India. It is not only good from the health perspective but also for the consumers.

JR Compliance - a leading compliance service provider is equipped with all the resources including keeping track of mandatory requirements of medical devices. We believe we are a perfect fit to meet your certification requirements because we have professional experience in completing voluntary BIS certification for medical equipment.

Indian Market is Filled With Unauthentic Medical Devices as CDSCO Pushed the New Registration Regime

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