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 )