On July 29th, 2025, AMCHAM’s Medical Devices Committee’s Subgroup on Regulatory Affairs had an engaging and in-depth meeting with Mr. Aseem Sahu, Deputy Drug Controller, Central Drugs Standard Control Organization (CDSCO), Government of India. The meeting focused on critical regulatory concerns faced by the MedTech industry, with an emphasis on collaborative resolution and streamlining processes to enhance ease of doing business and strengthen the ‘Make in India’ initiative. Key issues discussed included:

1. New Major Post-Approval Changes (PACs) Categories: Clarification was sought on newly introduced categories in the Medical Device (MD) Portal, including changes related to additional brand names, model numbers, and updates to IFUs/user manuals.
2. Sterilization as a Separate Device: Request for clarification on whether changes in the method of sterilization constitute a new device, as per FAQ Addendum No. 02.
3. MD-14 Application Upload Space: Concerns were raised over reduced upload space in fresh MD-14 applications — from 30MB to 10MB per section — impacting submission of high-risk device reports.
4. Loan License for Sterilization: A follow-up was made on the Drugs Technical Advisory Board/ Medical Devices Technical Advisory Group (DTAB/MDTAG) discussion confirming no requirement of a loan license for outsourcing of sterilization process and related labelling changes and requested a timeline for implementation.
5. AE (Adverse Event) and SAE (Serious Adverse Event) Reporting Guidance: Members sought clarity on current expectations and CDSCO’s plans for future rollout.
6. Test License Exemption: A strong case was made for exemption of test licenses for R&D and manufacturing purposes to support innovation under Make in India.
7. Veterinary Product Licensing: Members highlighted the challenge of obtaining NoCs from DAHD and proposed direct coordination between CDSCO and Department of Animal Husbandry and Dairying (DAHD) for efficiency.
8. Class C & D Manufacturing Approvals: Issues around duplicative review processes at the zonal and central level were raised, urging a more streamlined pathway to avoid delays.
9. Alternate Manufacturing Site Registrations: Members proposed a faster review mechanism for already approved products being registered with a new LM/PM site, given no change in manufacturing process, product specs or performance.
10. Parametric Release Implementation: Clarification was sought on whether implementation of parametric release under FAQ guidance should be processed via PAC.
11. Import Clearance & Retention: Concerns were raised over customs delays due to insistence on copy of retention approvals, even when fee submission is complete. Members urged alignment with MDR 2017 which ensures license validity in perpetuity upon timely fee payment.

AMCHAM conveyed sincere appreciation to Mr. Sahu and CDSCO for their openness to dialogue and constructive engagement on key regulatory matters. The meeting marked a valuable step towards improving regulatory clarity, efficiency, and fostering greater industry-government collaboration.