Quality Certifications In Medical Device Sector

5. IAF is creating a database of certificates – see link https://www.iafcertsearch.org/ - you can verify your certificate on this website. However, this database is new and is in the process of being developed – so absence on this website does not mean your certificate is not genuine.

6. All CBs are authorized to issue certificates for Standards and Scope Sectors for which they have been accredited by the respective Abs.

7. The national AB in India is NABCB. Currently, NABCB provides accreditation for a number of management systems standards which includes ISO 9001 as well as ISO 13485.

8. Go to NABCB website and click on ‘Accredited CBs and Ibs’; select ‘MDQMS’ from the list.

9. You will be able to view the list of Cbs accredited by NABCB. The list has 11 names currently. Are you able to find the name of the CB of your interest? If YES, go to next Step; if NO go to Step 11.

10. Click on the name of the CB selected and look for the following 2 facts:
    a. Whether the CB is authorized to certify for Scope Sector in which your activity falls; and
    b. The date on the MDQMS certificate issued is within the date range of ‘Valid from’ and ‘Valid upto’ If it meets both these conditions, the certificate is VALID.

11. It is likely that the CB is authorized by an AB of some other country as ascertained in Step 4.

12. In such a case, go to the AB’s website as given on IAF website and repeat steps 8 to 10 by clicking on the name of the CB.

13. Each CB has to provide a means of verifying its certificates – you can use the mechanism to verify that the certificate is in CB’s database especially if your certificate has been issued through a franchisee of a foreign CB.

14. Some ABs also provide a means of verifying certificates issued under their accreditation – you can check on the concerned AB website.

15. In case you still have doubt, refer the copy of the certificate to NABCB for verification at nabcb@qcin.org. It will help you verify even from foreign AB member of IAF. The same approach applies to verifying ISO certificate for any management systems standard say ISO 9001 or ISO 14001.

Certification Going Forward

As already indicated, even when medical devices are fully regulated, ISO 13485 certificate would remain relevant both for seeking audit time reduction under MDR, 2017 and international acceptability when seeking access to global markets.

Even though regulations typically do not prescribe or demand certification, many times the market or the buyers do. It is possible that buyers, esp government buyers, may demand BIS certification in addition to the licence you may get from the CDSCO or SLA.

QCI and AIMED had jointly launched an ICMED scheme which endeavoured to fill the regulatory vacuum that existed when it was launched in 2016. It was envisaged that it would be a vehicle to certify Indian industry to international standards especially though its product certification variant ICMED Plus which is yet to be launched. This was designed to help Indian industry demonstrate compliance to international standards as exist in global markets, an option not available under BIS certification since it certifies only to BIS standards. Its felt that globally, standards demanded from the Indian industry would remain different from BIS standards unless BIS adopts all international standards and therefore ICMED scheme can serve the industry.

In the foreseeable future, CDSCO should consider providing consideration to voluntary certifications in its regulatory regime by, for example, recognizing any certification which meets its regulations fully or partially (only for QMS or for product compliance) by BIS or NABCB accredited CBs to reduce the regulatory oversight burden on it and the states. This is the approach which is gaining ground in other sectors globally and CDSCO, and indeed other Indian regulators, should be leading such developments rather than following them.

Conclusion

The above narration indicates that voluntary certification in medical devices sector would remain relevant even after devices are fully regulated under MDR, 2017. Should CDSCO provide consideration to them as has been suggested in previous para, the value of voluntary certifications would increase further. It would be important that each manufacturer weighs the benefits of holding certification and chooses the right certification with authentic accreditation which provides maximum benefit to it in the market.

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