India medical device regulations

Class A non-sterile and non-measuring devices have a separate online registration framework under Rules19G-19M and the stated Eighth Schedule exemptions. The licensed major/minor PAC and constitution-clock answers must therefore not be applied to that subset without checking the registration route and its actual recorded information.

The official Import License(Form MD-14) PAC label table marks the old/new label comparison with reasons, revised label and PAC application as mandatory. It marks an existing licence/retention with cover letter, foreign approval and packaging-validation evidence as No or conditional as printed. This is the listed import-PAC branch, not a dedicated subsequent-importer checklist.

Rule 46 (as substituted by G.S.R. 918(E) with effect from 31 December 2021) requires every device approved for manufacture or import to bear a unique device identification from a date and in a manner to be specified by Central Government order. The substituted rule does not itself establish a calendar date for UDI marking.

The MD FAQ says that, for an Indian-agent-owned brand registered under the Trade Marks Act, 1999 and entered in Form MD-14, the brand must be present on the FSC issued to the legal manufacturer by one of the named reference-country authorities; otherwise the brand field is to be Not Applicable. This guidance concerns that import application field and is not a requirement to reissue every FSC for every artwork edit.

For a medical device in the licensed manufacture/import regime, an actual major change specified in the Sixth Schedule requires prior approval. Rule26(iii) requires the manufacture licensing authority to indicate approval or rejection within45 days; Rule38(1)(v)-(vi) gives the import authority60 days. Each provision states that no communication within its stipulated period deems the change approved. For an actual listed minor change, Rules26(iv) and38(1)(vii) require notification within30 days after the change. These are distinct authority decision periods and an applicant notification deadline, not an end-to-end project estimate or a fresh-licence approval clock.

For licensed devices and IVDs, a substantive change to approved label information is a major change under Sixth Schedule A7. Changes only to font size, font type, colour or label design are excluded from that major-change entry. An exclusion from A7 is not, by itself, a positive notification exemption or a classification of every logo edit as a listed minor change.

Class A non-sterile and non-measuring devices have a separate online registration framework under Rules19G-19M and the stated Eighth Schedule exemptions. The licensed major/minor PAC and constitution-clock answers must therefore not be applied to that subset without checking the registration route and its actual recorded information.

For a licensed product, Sixth Schedule A6 lists a change in the name or address of the overseas manufacturer or its manufacturing site, domestic manufacturer or its site, and Indian authorised agent as a major change. A same-entity office-address or company-name change is assessed through this change procedure; it is not automatically a factory relocation or a change in constitution.

The official Import License(Form MD-14) PAC label table marks the old/new label comparison with reasons, revised label and PAC application as mandatory. It marks an existing licence/retention with cover letter, foreign approval and packaging-validation evidence as No or conditional as printed. This is the listed import-PAC branch, not a dedicated subsequent-importer checklist.

The import PAC table for overseas manufacturer or manufacturing-site name without a constitution change requires the PAC application and reason, existing licence/retention documentation, authenticated power of attorney with agent undertaking, origin site/establishment registration and quality certificates showing the name change. Its FSC row is marked No; several label/PMF/undertaking rows are also marked No. Do not replace those flags with a universal all-certificates-first requirement.

For a medical device in the licensed manufacture/import regime, an actual major change specified in the Sixth Schedule requires prior approval. Rule26(iii) requires the manufacture licensing authority to indicate approval or rejection within45 days; Rule38(1)(v)-(vi) gives the import authority60 days. Each provision states that no communication within its stipulated period deems the change approved. For an actual listed minor change, Rules26(iv) and38(1)(vii) require notification within30 days after the change. These are distinct authority decision periods and an applicant notification deadline, not an end-to-end project estimate or a fresh-licence approval clock.

Labels must bear the device name, net quantity, month/year of manufacture and expiry (or shelf life), lot/batch number, storage conditions, sterile state and sterilisation method, single-use indication where relevant, and warnings; imported devices add, by stickering where not printed, the import licence number, importer name and address, manufacturing premises address and date of manufacture; BIS or ISO symbols may replace text.

Rule 46 (as substituted by G.S.R. 918(E) with effect from 31 December 2021) requires every device approved for manufacture or import to bear a unique device identification from a date and in a manner to be specified by Central Government order. The substituted rule does not itself establish a calendar date for UDI marking.

The MD FAQ says that, for an Indian-agent-owned brand registered under the Trade Marks Act, 1999 and entered in Form MD-14, the brand must be present on the FSC issued to the legal manufacturer by one of the named reference-country authorities; otherwise the brand field is to be Not Applicable. This guidance concerns that import application field and is not a requirement to reissue every FSC for every artwork edit.

For licensed devices and IVDs, a substantive change to approved label information is a major change under Sixth Schedule A7. Changes only to font size, font type, colour or label design are excluded from that major-change entry. An exclusion from A7 is not, by itself, a positive notification exemption or a classification of every logo edit as a listed minor change.

Class A non-sterile and non-measuring devices have a separate online registration framework under Rules19G-19M and the stated Eighth Schedule exemptions. The licensed major/minor PAC and constitution-clock answers must therefore not be applied to that subset without checking the registration route and its actual recorded information.

For a licensed product, Sixth Schedule A6 lists a change in the name or address of the overseas manufacturer or its manufacturing site, domestic manufacturer or its site, and Indian authorised agent as a major change. A same-entity office-address or company-name change is assessed through this change procedure; it is not automatically a factory relocation or a change in constitution.

The official Import License(Form MD-14) PAC label table marks the old/new label comparison with reasons, revised label and PAC application as mandatory. It marks an existing licence/retention with cover letter, foreign approval and packaging-validation evidence as No or conditional as printed. This is the listed import-PAC branch, not a dedicated subsequent-importer checklist.

The import PAC table for overseas manufacturer or manufacturing-site name without a constitution change requires the PAC application and reason, existing licence/retention documentation, authenticated power of attorney with agent undertaking, origin site/establishment registration and quality certificates showing the name change. Its FSC row is marked No; several label/PMF/undertaking rows are also marked No. Do not replace those flags with a universal all-certificates-first requirement.

For an overseas legal-manufacturer address change without constitution change, the import-PAC table requires the application/reason, authenticated power of attorney and agent undertaking, manufacturer no-constitution-change undertaking, notarised origin site/establishment registration, a notarised reference-country FSC and quality-certificate evidence. This office branch is distinct from physically relocating a manufacturing site.

For a medical device in the licensed manufacture/import regime, an actual major change specified in the Sixth Schedule requires prior approval. Rule26(iii) requires the manufacture licensing authority to indicate approval or rejection within45 days; Rule38(1)(v)-(vi) gives the import authority60 days. Each provision states that no communication within its stipulated period deems the change approved. For an actual listed minor change, Rules26(iv) and38(1)(vii) require notification within30 days after the change. These are distinct authority decision periods and an applicant notification deadline, not an end-to-end project estimate or a fresh-licence approval clock.

Labels must bear the device name, net quantity, month/year of manufacture and expiry (or shelf life), lot/batch number, storage conditions, sterile state and sterilisation method, single-use indication where relevant, and warnings; imported devices add, by stickering where not printed, the import licence number, importer name and address, manufacturing premises address and date of manufacture; BIS or ISO symbols may replace text.

Rule 46 (as substituted by G.S.R. 918(E) with effect from 31 December 2021) requires every device approved for manufacture or import to bear a unique device identification from a date and in a manner to be specified by Central Government order. The substituted rule does not itself establish a calendar date for UDI marking.

The MD FAQ says that, for an Indian-agent-owned brand registered under the Trade Marks Act, 1999 and entered in Form MD-14, the brand must be present on the FSC issued to the legal manufacturer by one of the named reference-country authorities; otherwise the brand field is to be Not Applicable. This guidance concerns that import application field and is not a requirement to reissue every FSC for every artwork edit.

Class A non-sterile and non-measuring devices have a separate online registration framework under Rules19G-19M and the stated Eighth Schedule exemptions. The licensed major/minor PAC and constitution-clock answers must therefore not be applied to that subset without checking the registration route and its actual recorded information.

The import-PAC model-number table requires proposed details, old/new comparison with justification, existing licence/retention, predicate or similar-device reference, relevant DMF and Essential Principles changes, risk report, proposed label, applicable test reports, three-batch release/analysis evidence and notarised FSC/quality certificates. Use this table only if the changed order code is actually the registered model field.

Rule 46 (as substituted by G.S.R. 918(E) with effect from 31 December 2021) requires every device approved for manufacture or import to bear a unique device identification from a date and in a manner to be specified by Central Government order. The substituted rule does not itself establish a calendar date for UDI marking.

The official Import License(Form MD-14) PAC label table marks the old/new label comparison with reasons, revised label and PAC application as mandatory. It marks an existing licence/retention with cover letter, foreign approval and packaging-validation evidence as No or conditional as printed. This is the listed import-PAC branch, not a dedicated subsequent-importer checklist.

For a medical device in the licensed manufacture/import regime, an actual major change specified in the Sixth Schedule requires prior approval. Rule26(iii) requires the manufacture licensing authority to indicate approval or rejection within45 days; Rule38(1)(v)-(vi) gives the import authority60 days. Each provision states that no communication within its stipulated period deems the change approved. For an actual listed minor change, Rules26(iv) and38(1)(vii) require notification within30 days after the change. These are distinct authority decision periods and an applicant notification deadline, not an end-to-end project estimate or a fresh-licence approval clock.

Labels must bear the device name, net quantity, month/year of manufacture and expiry (or shelf life), lot/batch number, storage conditions, sterile state and sterilisation method, single-use indication where relevant, and warnings; imported devices add, by stickering where not printed, the import licence number, importer name and address, manufacturing premises address and date of manufacture; BIS or ISO symbols may replace text.

The MD FAQ says that, for an Indian-agent-owned brand registered under the Trade Marks Act, 1999 and entered in Form MD-14, the brand must be present on the FSC issued to the legal manufacturer by one of the named reference-country authorities; otherwise the brand field is to be Not Applicable. This guidance concerns that import application field and is not a requirement to reissue every FSC for every artwork edit.

For licensed devices and IVDs, a substantive change to approved label information is a major change under Sixth Schedule A7. Changes only to font size, font type, colour or label design are excluded from that major-change entry. An exclusion from A7 is not, by itself, a positive notification exemption or a classification of every logo edit as a listed minor change.

Class A non-sterile and non-measuring devices have a separate online registration framework under Rules19G-19M and the stated Eighth Schedule exemptions. The licensed major/minor PAC and constitution-clock answers must therefore not be applied to that subset without checking the registration route and its actual recorded information.

A subsequent importer is a new Indian authorised agent seeking an import licence for a device already licensed to another agent with the same legal and actual manufacturer/site. The MD FAQ lists MD-14, POA, FSC, fees, agent eligibility licence/MD-42, label, IFU, earlier agent import licence and a manufacturer no-DMF/PMF-change undertaking. This is not automatic transfer of the earlier import licence and does not establish a route for a new foreign legal manufacturer.

The official Import License(Form MD-14) PAC label table marks the old/new label comparison with reasons, revised label and PAC application as mandatory. It marks an existing licence/retention with cover letter, foreign approval and packaging-validation evidence as No or conditional as printed. This is the listed import-PAC branch, not a dedicated subsequent-importer checklist.

For a medical device in the licensed manufacture/import regime, an actual major change specified in the Sixth Schedule requires prior approval. Rule26(iii) requires the manufacture licensing authority to indicate approval or rejection within45 days; Rule38(1)(v)-(vi) gives the import authority60 days. Each provision states that no communication within its stipulated period deems the change approved. For an actual listed minor change, Rules26(iv) and38(1)(vii) require notification within30 days after the change. These are distinct authority decision periods and an applicant notification deadline, not an end-to-end project estimate or a fresh-licence approval clock.

Labels must bear the device name, net quantity, month/year of manufacture and expiry (or shelf life), lot/batch number, storage conditions, sterile state and sterilisation method, single-use indication where relevant, and warnings; imported devices add, by stickering where not printed, the import licence number, importer name and address, manufacturing premises address and date of manufacture; BIS or ISO symbols may replace text.

Rule 46 (as substituted by G.S.R. 918(E) with effect from 31 December 2021) requires every device approved for manufacture or import to bear a unique device identification from a date and in a manner to be specified by Central Government order. The substituted rule does not itself establish a calendar date for UDI marking.

The MD FAQ says that, for an Indian-agent-owned brand registered under the Trade Marks Act, 1999 and entered in Form MD-14, the brand must be present on the FSC issued to the legal manufacturer by one of the named reference-country authorities; otherwise the brand field is to be Not Applicable. This guidance concerns that import application field and is not a requirement to reissue every FSC for every artwork edit.

Class A non-sterile and non-measuring devices have a separate online registration framework under Rules19G-19M and the stated Eighth Schedule exemptions. The licensed major/minor PAC and constitution-clock answers must therefore not be applied to that subset without checking the registration route and its actual recorded information.

For a licensed product, Sixth Schedule A6 lists a change in the name or address of the overseas manufacturer or its manufacturing site, domestic manufacturer or its site, and Indian authorised agent as a major change. A same-entity office-address or company-name change is assessed through this change procedure; it is not automatically a factory relocation or a change in constitution.

The import-PAC model-number table requires proposed details, old/new comparison with justification, existing licence/retention, predicate or similar-device reference, relevant DMF and Essential Principles changes, risk report, proposed label, applicable test reports, three-batch release/analysis evidence and notarised FSC/quality certificates. Use this table only if the changed order code is actually the registered model field.

Rule 46 (as substituted by G.S.R. 918(E) with effect from 31 December 2021) requires every device approved for manufacture or import to bear a unique device identification from a date and in a manner to be specified by Central Government order. The substituted rule does not itself establish a calendar date for UDI marking.

A change in constitution of the licensee (including the overseas manufacturer that executed the power of attorney) triggers a fresh licence application within 180 days of the change; the existing licence remains valid until the fresh licence is issued or the application is rejected.

A subsequent importer is a new Indian authorised agent seeking an import licence for a device already licensed to another agent with the same legal and actual manufacturer/site. The MD FAQ lists MD-14, POA, FSC, fees, agent eligibility licence/MD-42, label, IFU, earlier agent import licence and a manufacturer no-DMF/PMF-change undertaking. This is not automatic transfer of the earlier import licence and does not establish a route for a new foreign legal manufacturer.

The official Import License(Form MD-14) PAC label table marks the old/new label comparison with reasons, revised label and PAC application as mandatory. It marks an existing licence/retention with cover letter, foreign approval and packaging-validation evidence as No or conditional as printed. This is the listed import-PAC branch, not a dedicated subsequent-importer checklist.

The import PAC table for overseas manufacturer or manufacturing-site name without a constitution change requires the PAC application and reason, existing licence/retention documentation, authenticated power of attorney with agent undertaking, origin site/establishment registration and quality certificates showing the name change. Its FSC row is marked No; several label/PMF/undertaking rows are also marked No. Do not replace those flags with a universal all-certificates-first requirement.

For an overseas legal-manufacturer address change without constitution change, the import-PAC table requires the application/reason, authenticated power of attorney and agent undertaking, manufacturer no-constitution-change undertaking, notarised origin site/establishment registration, a notarised reference-country FSC and quality-certificate evidence. This office branch is distinct from physically relocating a manufacturing site.

For a medical device in the licensed manufacture/import regime, an actual major change specified in the Sixth Schedule requires prior approval. Rule26(iii) requires the manufacture licensing authority to indicate approval or rejection within45 days; Rule38(1)(v)-(vi) gives the import authority60 days. Each provision states that no communication within its stipulated period deems the change approved. For an actual listed minor change, Rules26(iv) and38(1)(vii) require notification within30 days after the change. These are distinct authority decision periods and an applicant notification deadline, not an end-to-end project estimate or a fresh-licence approval clock.

Labels must bear the device name, net quantity, month/year of manufacture and expiry (or shelf life), lot/batch number, storage conditions, sterile state and sterilisation method, single-use indication where relevant, and warnings; imported devices add, by stickering where not printed, the import licence number, importer name and address, manufacturing premises address and date of manufacture; BIS or ISO symbols may replace text.

The MD FAQ says that, for an Indian-agent-owned brand registered under the Trade Marks Act, 1999 and entered in Form MD-14, the brand must be present on the FSC issued to the legal manufacturer by one of the named reference-country authorities; otherwise the brand field is to be Not Applicable. This guidance concerns that import application field and is not a requirement to reissue every FSC for every artwork edit.