Request for Consideration : Ease of doing Business : MedTech Regulatory Operational challenges in retention of import license and subsequent endorsements

Aug 9, 2023 | Medical Devices Committee

Medical Device Committee Regulatory Team met with Mr Aseem Sahu on 28th July at CDSCO and addressed the Operational Challenges in retention of Import Licese and subsequnet endorsements and other major concerns. As advised by Mr Sahu, AMCHAM submitted the recommedations for consideration and shared Issues/Recommendations and Rationals to improve
1. Pdf copy Original/Retained IL and originally submitted documents
2. Lack of Visibility of Model numbers in Retained IL
3. Generation of challan (post payment) at BharatKosh portal is not consistent
4. Removal of model numbers -no option available to remove the model numbers at the time of retention application submission or via post approval change.
5. Post Approval Changes – reflected in MD-14 but not in MD-15 license

Request for Consideration : E- Waste Management Guidelines

Aug 1, 2022 | Medical Devices Committee

AMCHAM’s Medical Device Committee made a representation on consideration to exempt medical devices as listed under Schedule I of S.O. 360 (E) to Ms. Leena Nandan, Secretary, Ministry of Environment, Forest and Climate Change on August 1st, 2022. The representation highlighted issues such as steps to prevent the spread of contamination, preserving patients’ data integrity, supporting the circular economy and helping in cost savings by usage of old equipment in new centres/Class 2 and 3 Ayusman Bharat Hospitals.

Request for Consideration: Streamlining Medical Device Registration process/ Regulatory Challenges

Aug 1, 2022 | Medical Devices Committee

AMCHAM’s Medical Device Committee made a representation on streamlining medical device registration process/regulatory challenges to Major General Mohammad Yousuf, Director General, Directorate General of Drug Administration, Ministry of Health & Welfare, Bangladesh on August 1st, 2022. The recommendation highlighted DGDA capacity challenges, handling of administrative changes like manufacturer name change and M.R P. (Maximum Retail Price) to help industry stakeholders to obtain faster approvals thereby enabling Bangladesh patients’ access to affordable, new, innovative and novel medical technology devices.

Representation – Inputs on Innovation & R&D on the Draft Drugs, Medical Device & Cosmetics Bill 2022

Jul 20, 2022 | Medical Devices Committee

AMCHAM Medical Device Committee submitted recommendations to use TMR from PTD as a pricing mechanism to make medical devices more affordable for the patients. AMCHAM recommendations also suggested Therapeutic /Price band approach. Recommended to have a detailed industry consultations separately to evolve a suitable methodology for identifying products which need to go for TMR. Recommendations also highlighted that TMR should not applied on B2B products like capital equipment, IVD Bulk reagents and others sold to labs and hospitals which are not billed to the consumers. Regarding Percentage of TMR – supported the DoP report of the committee on High Trade Margin in the sale of Drugs. TMR should have a graded margin depending upon product category. Creation of a legal provision to incorporate TMR from PTD, Stents should also be considered for TMR based pricing, IPDMS instead of Paper format and well documented guidelines on how to calculate the PDT and PTS to avoid confusions were additional points submitted as recommendations

AMCHAM Medical Device Committee’s input on Trade Margin Rationalization of Non-Scheduled Medical Devices

Jun 1, 2022 | Medical Devices Committee

Medical Device Committee submitted the observations and shared inputs /suggestions to improve the Research development of Medical Devices”. Submitted recommendations pertaining Standards of Medical Devices – AMCHAM industry members believes that this is a very pragmatic approach and hope that emphasis will be laid on horizontal QMS standards and onus will be on the innovative medical Device Companies to establish compliance with functional standards based on Essential Principles of Safety and performance of medical devices, rather than dogmatic old product standards which stifles innovation. Another submission was about Transitory Provisions & Repeal and Savings. AMCHAM welcomes the move on continuation of Nineth Schedule Rules, namely: The Medical Devices Rules, 2017 & The New Drugs and Clinical Trials Rules, 2019. These Rules are created after detailed consultation and conforms to the best practices. Regarding non-compliance with quality standards –submitted recommendation to draft a Standard Operating Procedure on Causality Analysis for adverse events before proceeding with such clauses. The proposed act should define a proper mechanism to do the causality analysis of any adverse event on patient, before establishing whether the drugs, /devices are indeed spurious or adulterated or misbranded. Give our full support to work closely with regulators – to ensure patient safety and compensation but also to eliminate the harsher clauses which may deter launch of differentiated technologies.”