A consultation focused on domestic manufacture
India’s Central Drugs Standard Control Organization (CDSCO) made draft manufacturing guidance for in vitro diagnostic medical devices public on 9 October 2026. The document is numbered CDSCO/IVD/GD/DRAFT/MFG/01/2026 and requests stakeholder comments within 15 days of publication.
Its stated scope is domestic IVD manufacture under the Medical Devices Rules, 2017 and the Drugs and Cosmetics Act, 1940. The draft discusses manufacturing test licences, fresh applications, product endorsements, loan licences and retention. It is not a general import licensing guide for every company supplying IVDs to India.
The document remains a consultation draft. Its notice also describes its public-awareness purpose and directs readers to statutory provisions, amendments and current official clarifications. The publication should not be reported as introducing newly effective legal obligations on 9 October.
Distinguish the manufacturing activity and licence route
The draft describes Form MD-12 applications for manufacturing small quantities across device risk classes for testing, evaluation, clinical investigations, demonstration or training, with Form MD-13 as the corresponding licence. The device description section states that such products are not intended for commercial sale or routine clinical use. A test licence should therefore not be equated with commercial manufacturing authorisation.
For manufacturing for sale or distribution, the draft assigns Class A and B licensing to the State Licensing Authority and Class C and D licensing to the Central Licensing Authority. It separates own-site manufacturing applications from loan licence applications, and distinguishes fresh, endorsement and retention documentation.
A loan licence has a specific regulatory meaning: using another licensee’s manufacturing site to manufacture the same medical device manufactured by that licensee at that site. A commercial outsourcing arrangement should not automatically be assumed to meet that definition.
Inspection timing also depends on the route. In its section on Class A and B licences granted under Rule 20, the draft states that no pre-grant site audit is needed for Class A, while a registered Notified Body audit must occur within 120 days of grant. For Class B, the audit is described as occurring within 90 days of application. Class C and D licensing requires a pre-grant inspection within 60 days of application under Rule 23. These statements concern the licensing situations described in the draft; they do not establish that every Class A IVD requires a manufacturing licence.
Use the draft to assess application consistency
The proposed documentation covers intended use, performance evaluation, risk management, plant and device master files, quality systems, stability and labelling. A useful preliminary assessment is whether the documentation consistently describes the same analyte, specimen, intended user and use setting. The draft’s detailed intended-use instructions make these relationships explicit, rather than simply presenting a list of file names.
Retention is also distinguished from a fresh application. The draft describes manufacturing licences as valid in perpetuity subject to payment of retention fees before completion of five years from issue, including relevant site and device fees and submission of retention documentation. That is not an unconditional statement that no further regulatory action is required, nor should it be loosely described as a complete re-registration every five years.
The official comment window is 15 days from publication. Adding 15 calendar days to 9 October yields 24 October as an arithmetic reference; the notice does not itself state that fixed deadline. Stakeholders should follow the official notice and submission arrangements when planning a response.
For domestic projects, the draft can support an assessment of licence type and consistency between application sections. A project limited to finished-product imports should first establish the applicable import route rather than transfer manufacturing procedures into its submission.
Sources
- Primary official sourceGuidance document for Manufacturers for In-Vitro Diagnostic Medical Device — CDSCO/IVD/GD/DRAFT/MFG/01/2026 (opens in a new tab)Central Drugs Standard Control Organization
- Supporting sourceCDSCO Public Notices (opens in a new tab)Central Drugs Standard Control Organization