30 COVERStory
BioSpectrum | November 2017 | www. biospectrumindia. com
Association of Indian Medical Device Industry( AIMED) Recommendations
Who will the Indian National Medical Devices Regulator Regulate?
The currently proposed Regulatory Framework proposes CDSCO(& SLA) to continue to regulate the Manufacturer, CDSCO for the Importer and to delegate the Regulation of Trading Company to the State Licensing Authority. Our Proposal, in Line with the Japanese Regulatory System, is as follows The CDSCO should regulate the Importer, the Manufacturer( and the specific Manufacturer Site) and the Market Access Authorization Holder( whether the MAAH is the Manufacturer or Marketing Company or an Authorized Agent of the Overseas Manufacturer) and the SLA regulates the Domestic Reseller – Wholeseller OR Retailer OR Healthcare Provider. Not considered,( Against Make in India)
What will be regulated to ensure patient safety?
Only Devices notified as drug will be regulated. Devices which are not notified will be encouraged to go for ICMED certification. For manufacturers who have got ICMED Certification, on getting Notified, the ICMED Certification needs to be recognized and there should then be no need to have a premarket mandatory audit by another Notified Body. This provision should be added at the end of rule 20. Not considered( Against Make in India & Ease of Doing Business)
Reference Rule 1 These rules shall come in force w. e. f. 01 / 01 / 2018( unless specified otherwise) We would suggest a transition period of minimum 2 – 3 years should be given for capacity building for implementing these rules without a procedure for Registration and announcing any Notified Bodies, to register / license 1000 Manufacturers in 225 days is farfetched and target. Not considered( an inadequate transition period of only 11 months has been given)
Reference Rule 20( 4)( ii) For a Manufacturer making Class A Medical Device Compliance with fifth Schedule will be very difficult and unwarranted. We would suggest that for Class A Manufacturer a Certification from a Accredited Notified Body for the Compliance with IS / ISO 9001 should suffice and there will be no need to demonstrate Compliance with fifth Schedule. Not considered( Against Make in India & Ease of Doing Business)
Reference Rule 20( 1) This rule specifies that manufacturing license will be required from State Licensing Authority for the Manufacture of Class A & Class B Medical Devices. Whereas as per earlier draft Class A Medical Devices were to be self-regulated with simple online registration( this provision was added after detailed deliberations and discussion among the stake holders) we would suggest that provision of self-regulation with simple online registration for Class A Devices should be retained and no need for applying for a Manufacturing License. Not considered( Against Make in India and Ease of Doing Business)
Reference Rule 47 This Rule permits import of Medical Devices having Residual Self Life as low as 40 %. We would strongly recommend that any Medical Device having less than 2 / 3rd Residual Self Life should not be allowed for import. Not Considered( Against Make in India)
Reference Rule 79 The term adulterated is not appropriate for Medical Devices, so this should be deleted. Not Considered( Against Make in India & Ease of Doing Business)
Reference First Schedule Part I Classification of Medical Devices other than In vitro diagnostic Medical Devices: We have noted that the Rules seem to be based on GHTF Guidelines.( with language modified) whereas the classification rules circulated with earlier draft were as per European Directives. The rules in EU Directives & GHTF Guidelines are not significantly different but the language in EU Directive is simpler. We would suggest that classification rules based upon EU Directives should be adopted and examples for each of the applicable rules should also be included. Not Considered( Against Ease of Doing Business)