In a major victory to the industry, the government has conceded three major recommendations of the medical device sector. After a long wait the government has finally agreed to set up a separate regulatory framework and law for the medical devices industry.
In fact keeping in the interest of the stakeholders, the CDSCO has also conceded to have a separate rulebook for medical devices for import, manufacture, clinical investigation and sale under the Drugs and Cosmetics Act until its regulatory framework is in place.
This move comes as huge relief for the stakeholders as a separate rule-book will enable prompt and timely redressal of the manufacturers issues. While bringing in more confidence and clarity to its members on different regulatory aspects. Once medical devices bill comes into place these rules will be added to it subsequently.
Interestingly in a win-win situation that is aimed at sprucing up the morale of the industry, the Centre has also agreed on the utilisation of NABCB accredited third party conformity assessment bodies for QMS quality audit. In case of products approved by any one of the GHTF countries, FSC or CFG from the GHTF countries will be insisted. In case of others, the certifying bodies should be accredited by international accreditation forum or by NABCB with FSC.
While the industry expressed huge relief over the government’s decision they did suggest some changes to the proposed regulations in a recent meeting held in Delhi.
Under the proposed rules, the health ministry plans to delegate the QMS compliance audit through a third party notified confirmatory assessment bodies and have online registration for class A and class B devices. However, it is understood that the Centre wish to directly regulate class C and class D i.e. the moderately high risk and high risk devices under a licensing system.
Rajiv Nath, forum coordinator of AIMED strongly feels that the Centre should allow even class C and class D category of devices to be audited though QMS notified body, while the license should be given by the regulator on review of the technical file with pre-market data and the clinical data.
Nath pointed out that medical devices needs to be regulated on risk proportionate basis, the higher the class of risk, the more should be the regulatory control.
Medical devices usually are categorized in four risk classifications, class A, B, C and D. Class A are low risk devices, examples are wheel chairs, spectacles etc; while class B includes low moderate risk devices, like syringes with needles and urinarary catheters. Class C are moderate high-risk devices, examples are dialysers and bone cement and class D are high-risk devices like cardiac catheters and heart valves.
Finally, Nath stressed that there is a need to have phased notification of devices based on preparedness of regulatory structures with sufficient transition time. The industry needs at least two to three years time to adjust to these new rules and three to five years to comply to the new Act once the medical device bill 2016 is passed, Nath said.