Medical Device License for OEM Manufacturers in West Bengal

OEM medical device manufacturing in West Bengal requires the parties to identify the correct regulatory structure before production begins. The applicable manufacturing approval depends substantially on device classification, intended use, manufacturing activities, site responsibility, and the arrangement between the brand owner and actual manufacturer. Quality systems, technical documentation, labelling, testing, inspection, and post-market controls also influence compliance. An OEM commercial arrangement cannot replace statutory licensing requirements or transfer regulatory responsibilities merely through contractual wording.

What Is an OEM Medical Device Manufacturer?

OEM manufacturing generally describes an arrangement in which one business manufactures a medical device, or performs defined manufacturing operations, for another entity that may market the finished product under its own commercial identity.

The parties can perform different functions. One entity may design the device, another may own the brand, while another operates the physical manufacturing facility. Similarly, a manufacturer may perform assembly, processing, packaging, testing, sterilisation, or complete production for another business.

However, commercial descriptions such as “OEM”, “brand owner”, or “contract manufacturer” do not independently determine regulatory status. The applicable legal arrangement, licence, manufacturing site, quality responsibilities, and device-specific requirements determine who can perform regulated activities.

Consequently, OEM parties should define regulatory responsibilities before commencing production.

Does Every OEM Manufacturer Need a Medical Device Manufacturing Licence?

Not every business participating in a medical device supply chain necessarily requires the same manufacturing approval. The regulatory position depends on what the entity actually does and how the Medical Devices Rules, 2017 apply to those activities.

An entity carrying out complete device manufacturing may require the appropriate manufacturing licence. Meanwhile, assembly, processing, packaging, sterilisation, or other operations can also become relevant when they form part of regulated manufacturing.

A business supplying ordinary components or raw materials does not automatically follow the same licensing route as the finished-device manufacturer. Nevertheless, supplier controls remain important under the manufacturer’s quality system.

Loan licence arrangements may be available where the legal conditions permit them, but an ordinary outsourcing agreement does not automatically qualify as a loan licence.

Regulatory Framework for Medical Device Manufacturing

OEM operations in West Bengal operate within India’s national medical device framework. The Medical Devices Rules, 2017 establish important requirements concerning classification, licensing, quality management, documentation, manufacture, import, labelling, and regulatory oversight.

Medical Devices Rules, 2017

The Rules create the principal regulatory structure for medical devices covered by the framework. They use risk-based classification and prescribe different pathways according to device class and regulated activity.

Accordingly, manufacturers should determine classification before choosing an application route. The Rules also address quality management requirements, technical evidence, inspections or audits where applicable, labelling, testing, and continuing responsibilities.

Relevant provisions of the Drugs and Cosmetics Act, 1940 also support the statutory framework under which regulated medical devices are controlled.

Role of the State Licensing Authority

The State Licensing Authority has licensing responsibilities for specified manufacturing pathways involving lower-risk devices under the Medical Devices Rules.

For an eligible manufacturing site located in West Bengal, the relevant state authority can therefore have an important role in applications falling within its jurisdiction.

However, applicants should determine jurisdiction from the device classification and licensing route rather than assuming that the physical location of every factory automatically makes every application a state-level matter.

Role of the Central Licensing Authority

The Central Licensing Authority handles specified medical device functions, including manufacturing licensing pathways for higher-risk device classes and other matters assigned to central jurisdiction.

Therefore, West Bengal manufacturers producing higher-risk devices may need to follow the applicable central licensing pathway even though their production premises remain within the state.

Medical Device Classification Before Licensing

India classifies medical devices according to risk. Classification directly affects the regulatory pathway, authority, scrutiny, documentation, and assessment requirements.

Class A Medical Devices

Class A represents the lowest-risk category within the four-class system. However, low risk does not mean absence of regulation.

Applicants must still identify whether their particular device falls within Class A and follow the requirements applicable to its regulatory status. Certain Class A devices can also receive differentiated regulatory treatment under applicable provisions.

Class B Medical Devices

Class B devices carry a higher risk profile than Class A devices. Consequently, their manufacturing pathway can involve additional regulatory controls and assessment requirements.

OEM parties should confirm classification using the applicable classification framework rather than assigning Class B status merely because a commercially similar product appears low risk.

Class C Medical Devices

Class C covers higher-risk devices and generally attracts greater regulatory scrutiny than Classes A and B.

Manufacturers should expect the device’s intended purpose, design, clinical or performance characteristics, technical evidence, risk management, manufacturing controls, and applicable validation requirements to influence the regulatory assessment.

Class D Medical Devices

Class D represents the highest-risk category. Consequently, manufacturing such devices can involve particularly significant regulatory scrutiny and technical evidence.

An OEM arrangement does not reduce a Class D device’s classification or allow the parties to substitute commercial quality arrangements for the applicable statutory licensing process.

Why Classification Matters for OEM Manufacturers

Classification should occur before an OEM selects its licensing route because it can influence:

• Appropriate licensing authority.
• Applicable application pathway.
• Quality-system assessment.
• Technical documentation.
• Testing and validation expectations.
• Inspection or audit requirements.
• Government fee structure.
• Regulatory scrutiny.
• Post-market responsibilities.

Incorrect classification can direct an applicant towards an unsuitable process and create inconsistencies throughout the technical file.

Therefore, businesses seeking a medical device license in West Bengal should first establish the intended use and correct risk classification of each regulated device.

Manufacturing Licence vs Loan Licence

Direct manufacturing and loan-licence arrangements represent distinct regulatory concepts. OEM parties should not treat them as interchangeable simply because both can involve manufacturing facilities.

Manufacturing Licence

A manufacturing licence generally authorises the licence holder to manufacture specified medical devices at an approved manufacturing site within the scope recognised by the applicable authority.

The applicant must satisfy requirements concerning the premises, quality system, equipment, technical documentation, personnel, testing arrangements, and other applicable controls.

Approval remains linked to its authorised scope. Consequently, the licence should not be treated as blanket permission to manufacture every medical device.

Loan Licence

A loan licence provides a regulatory mechanism under which an eligible applicant may use manufacturing facilities belonging to another appropriately licensed manufacturer, subject to the requirements governing that route.

However, not every contract-manufacturing or private-label arrangement constitutes a loan-licence arrangement.

The parties must determine whether their proposed structure legally fits the applicable route and allocate quality and regulatory responsibilities accordingly.

Who Should Apply for the Licence in an OEM Arrangement?

There is no universal answer based solely on who owns the brand. The appropriate applicant depends on the legal manufacturing structure and regulated activities.

Relevant considerations include:

• Who operates or controls the manufacturing premises.
• Which entity performs regulated manufacturing.
• Device classification.
• Applicable licence category.
• Quality-system responsibilities.
• Product-release controls.
• Contract-manufacturing structure.
• Whether a legally permissible loan-licence route applies.

A brand owner cannot assume that owning trademarks, specifications, or commercial rights automatically makes it the licensed manufacturer. Conversely, outsourcing physical production does not necessarily eliminate every regulatory responsibility of the entity placing the device on the market.

Eligibility Requirements for OEM Medical Device Manufacturers

An applicant should establish a compliant organisational and manufacturing framework appropriate to the devices it proposes to manufacture.

Relevant considerations can include:

• Legally constituted applicant entity.
• Suitable manufacturing premises.
• Appropriate technical resources.
• Implemented quality management system.
• Correct device classification.
• Suitable production equipment.
• Testing arrangements.
• Technical documentation.
• Controlled material and product storage.
• Record-keeping systems.
• Applicable regulatory permissions.

Specific personnel, infrastructure, testing, and documentation requirements depend on the device, class, processes, and licensing pathway. Therefore, applicants should not apply generic qualification criteria to every manufacturing facility.

Manufacturing Premises Requirements

A compliant site should support controlled and reproducible manufacturing appropriate to the medical devices produced there.

Depending on the processes, regulators or assessors may examine production areas, workflow, segregation, cleanliness, utilities, equipment, environmental conditions, storage, testing, and contamination controls.

Facilities should appropriately manage:

• Incoming materials.
• Work-in-progress products.
• Finished devices.
• Rejected or non-conforming materials.
• Testing activities.
• Equipment calibration.
• Controlled documentation.
• Production records.

Sterile, environmentally sensitive, or contamination-sensitive devices can require additional infrastructure and controls. Therefore, premises design should follow actual manufacturing risks rather than a standard factory layout.

Quality Management System Requirements

A quality management system should govern how the OEM consistently manufactures devices that meet approved specifications and regulatory requirements.

Important areas can include:

• Document and record control.
• Design controls where applicable.
• Supplier qualification and monitoring.
• Purchasing controls.
• Production procedures.
• Process validation.
• Equipment maintenance and calibration.
• Personnel training.
• Non-conforming product control.
• Corrective and preventive action.
• Complaint handling.
• Traceability.
• Internal audits.
• Management review.
• Change control.

The QMS should function in practice. Written procedures that employees do not follow provide weak evidence of manufacturing control.

Additionally, responsibilities shared between an OEM facility and brand owner should integrate with the relevant quality processes.

Technical Documentation Required for Licensing

Technical documentation establishes what the device is, what it is intended to do, how it is designed and manufactured, and what evidence supports its safety and performance.

Depending on device type and classification, documentation can address:

• Device description and specifications.
• Intended use.
• Classification rationale.
• Design information.
• Manufacturing processes.
• Essential principles compliance.
• Risk-management records.
• Verification and validation.
• Performance evidence.
• Biocompatibility where applicable.
• Electrical safety where applicable.
• Software validation where applicable.
• Sterilisation validation where applicable.
• Packaging validation.
• Shelf-life support.
• Labels and instructions for use.

Higher-risk or technologically complex devices can require more extensive evidence than straightforward lower-risk products.

Documents Commonly Required for an OEM Licence Application

The exact checklist depends on the device class, manufacturing structure, site, authority, and application route. Relevant records may include:

• Applicant constitution documents.
• Authorised signatory records.
• Manufacturing-site information.
• Ownership or lawful occupancy documents.
• Site-related information.
• Proposed device list.
• Classification information.
• Quality-system documentation.
• Technical personnel records where applicable.
• Equipment details.
• Manufacturing process flow.
• Testing arrangements.
• Product technical documentation.
• Proposed labels and instructions.
• OEM or manufacturing agreements where relevant.
• Required declarations.
• Government fee records.
• Additional device-specific documents.

All submissions should consistently identify the applicant, manufacturing site, devices, manufacturing roles, and responsible parties.

Step-by-Step Process for OEM Medical Device Licensing

A sound licensing process begins with the device itself and then determines classification, manufacturing structure, authority, site requirements, documentation, and assessment route.

Step 1: Identify the Device and Intended Use

Define the product clearly, including its intended medical purpose, users, patient population where relevant, operating principle, duration or nature of use, and significant technological characteristics.

Intended use is particularly important because classification and technical evidence can depend on what the manufacturer claims the device does.

Step 2: Confirm the Risk Classification

Apply the relevant classification principles to determine whether the device falls within Class A, B, C, or D.

Document the classification rationale. Incorrect classification can affect the authority, application route, evidence package, and subsequent regulatory assessment.

Step 3: Determine the OEM Regulatory Structure

Establish whether the applicant will manufacture at its own facility, outsource defined stages, use a contract manufacturer, or pursue another legally permissible licensing arrangement.

Commercial agreements should reflect, rather than attempt to replace, the regulatory structure.

Step 4: Identify the Appropriate Licensing Authority

Determine whether the applicable pathway falls under state or central licensing jurisdiction based on device class and the relevant provisions.

Do not choose an authority merely because the manufacturing facility is physically located in West Bengal.

Step 5: Prepare the Manufacturing Site

Configure premises, production areas, storage, utilities, equipment, testing arrangements, environmental controls, and material flows according to the devices and processes involved.

Site readiness should correspond with documented procedures.

Step 6: Establish the Quality Management System

Implement procedures governing production, suppliers, training, calibration, validation, non-conforming products, CAPA, complaints, traceability, records, audits, and changes.

Personnel should use these systems consistently before any applicable assessment.

Step 7: Compile Technical Documentation

Prepare device-specific technical records demonstrating design, intended purpose, classification, risk management, manufacturing, safety, performance, validation, and labelling.

Evidence should correspond to the actual device proposed for manufacture.

Step 8: Prepare and Submit the Application

Complete the application through the applicable regulatory process using the route prescribed for the relevant class and licensing arrangement.

Ensure that site, applicant, device, and supporting-document information remains consistent throughout the submission.

Step 9: Pay Applicable Government Fees

Pay the fees prescribed for the applicable regulatory transaction. The amount can depend on the licensing route, device category, number of devices, and prevailing regulatory provisions.

Applicants should verify the applicable fee rather than relying on outdated figures.

Step 10: Complete Inspection or Audit Where Applicable

Depending on the regulatory pathway, the manufacturing site and quality system may undergo inspection, audit, or assessment by the competent regulatory mechanism or a notified body where the Rules assign such involvement.

Assessment scope varies according to the device and route.

Step 11: Address Regulatory Deficiencies

Respond accurately to observations or deficiencies. Correct procedural, technical, facility, documentation, validation, or quality-system shortcomings and provide supporting evidence where requested.

Incomplete responses can prolong assessment or leave substantive concerns unresolved.

Step 12: Receive the Manufacturing Approval

After satisfying applicable requirements, the applicant may receive authorisation covering the approved devices and manufacturing site.

Production and commercial supply should remain within the authorised scope and conditions.

Inspection and Audit Requirements

Assessment can examine whether documented controls correspond with actual manufacturing practices.

Potential review areas include:

• Premises and manufacturing workflow.
• Quality-system implementation.
• Production and batch records.
• Equipment maintenance.
• Calibration.
• Personnel responsibilities.
• Testing arrangements.
• Process validation.
• Product traceability.
• Complaint handling.
• CAPA.
• Labelling controls.
• Device documentation.
• Relevant OEM agreements.

The precise assessment mechanism depends on device class and licensing pathway.

Role of Notified Bodies

Notified bodies have defined functions within specified medical device regulatory pathways under the Rules. Their involvement can include quality-system or manufacturing-site assessment where the applicable framework assigns that responsibility.

However, every manufacturer does not necessarily undergo an identical notified-body process.

OEM applicants should determine whether notified-body involvement applies to their device class and licensing route rather than treating such assessment as universal.

Labelling Requirements for OEM-Manufactured Devices

Labelling should accurately represent the device and comply with applicable medical device requirements.

Depending on the product, required particulars can address manufacturer identification, device identity, batch or lot information, relevant manufacturing or expiry particulars, storage conditions, sterile status, warnings, and instructions.

OEM arrangements require particular care where the brand owner differs from the physical manufacturer. Commercial branding should not obscure information that applicable law requires the label to disclose.

Additionally, labels should remain consistent with the authorised product, intended use, technical documentation, and manufacturing arrangement.

Testing and Validation Requirements

Testing should demonstrate that a device meets applicable safety and performance requirements for its intended purpose.

Depending on the device, relevant evidence can involve:

• Performance testing.
• Biocompatibility evaluation.
• Electrical safety.
• Software verification and validation.
• Sterilisation validation.
• Packaging validation.
• Shelf-life evidence.
• Stability where relevant.
• Process validation.
• Risk-based verification.

Not every test applies to every product. The evidence programme should arise from device characteristics, materials, intended use, risks, applicable standards, and regulatory requirements.

Sterile Medical Device Manufacturing

Sterile devices require controls appropriate to maintaining the required sterility assurance throughout manufacture and the claimed shelf life.

Relevant areas can include controlled environments, contamination controls, sterilisation processes, process validation, packaging integrity, bioburden management, monitoring, and manufacturing records.

Where an external party performs sterilisation, the manufacturer should maintain appropriate supplier controls, agreements, validation evidence, and traceability.

Sterility requirements should not be applied indiscriminately to devices supplied non-sterile.

Software and Digital Medical Devices

Software that qualifies as a medical device, or software forming part of a regulated device, can require product-specific lifecycle and validation controls.

OEM arrangements involving software should address development responsibility, configuration, version management, verification, validation, cybersecurity risks where relevant, defect handling, and change control.

A software update can affect device performance or risk. Consequently, manufacturers should evaluate regulatory implications before implementing significant changes rather than treating software revisions as ordinary commercial updates.

Post-Licence Compliance Obligations

Regulatory responsibilities continue throughout manufacturing and market supply.

Manufacturers should maintain:

• An effective QMS.
• Manufacturing within approved scope.
• Production and batch records where applicable.
• Traceability.
• Controlled manufacturing changes.
• Complaint-handling procedures.
• CAPA systems.
• Applicable adverse-event reporting.
• Recall procedures.
• Current technical documentation.
• Required regulatory updates.
• Inspection readiness.
• Record retention.
• Compliant labelling.

Post-market information should also feed back into risk management and corrective action where appropriate.

Changes That May Require Approval or Intimation

Regulatory review may become necessary when significant details change after licensing.

Examples can include:

• Manufacturing-site relocation.
• Change in legal entity.
• Addition of devices.
• Significant process changes.
• New sterilisation methods.
• Major design modifications.
• Relevant personnel changes.
• Revised OEM arrangements.
• Additional production lines.

The required action may involve approval, amendment, notification, documentation updates, or another prescribed procedure depending on the change.

Manufacturers should assess regulatory impact before implementation.

OEM Agreements and Regulatory Responsibility

A written OEM agreement can clarify responsibilities between the commercial parties, but it cannot override statutory obligations.

The agreement should appropriately address:

• Manufacturing responsibilities.
• Quality control.
• Testing and acceptance.
• Product release.
• Supplier controls.
• Complaint handling.
• Adverse-event communication.
• Recall coordination.
• Regulatory correspondence.
• Change control.
• Technical documentation.
• Confidentiality.
• Audit rights.

Responsibilities should also align with the quality system. For example, a contractual change-control clause provides limited protection if one party changes materials or processes without completing the required quality and regulatory assessment.

Cost of Medical Device Licensing

Total expenditure extends beyond government application fees. Costs depend on device class, number of devices, manufacturing model, site condition, technology, and evidence requirements.

Potential cost areas include:

• Government fees.
• Manufacturing infrastructure.
• QMS implementation.
• Equipment.
• Calibration and maintenance.
• Product testing.
• Process validation.
• Technical documentation.
• Sterilisation validation where relevant.
• Audit or assessment activities where applicable.
• Premises improvements.
• Voluntary professional assistance.

A higher-risk or technically complex device may require substantially different evidence and infrastructure from a straightforward lower-risk product. Therefore, one universal licensing budget would be misleading.

How Long Can the Licensing Process Take?

Processing time depends on the specific application rather than a guaranteed standard period.

Important variables include device classification, submission completeness, technical-file quality, manufacturing-site readiness, quality-system maturity, applicable inspection or audit requirements, testing evidence, and regulatory queries.

Deficiencies involving classification, intended use, validation, manufacturing arrangements, or inconsistent documentation can require additional responses.

Applicants should therefore prepare the technical and quality systems before submission instead of relying on a fixed commercial launch date.

Licence Validity, Retention, and Continuation

Manufacturers should follow the current provisions governing licence continuation, applicable retention requirements, amendments, and maintenance of regulatory status.

They should not rely on older assumptions that every approval follows a traditional periodic renewal model.

A compliance calendar can track applicable payments, regulatory submissions, approved devices, manufacturing-site details, reportable changes, and other continuing requirements. Failure to maintain the licence according to current provisions can affect lawful manufacturing.

Common OEM Licensing Mistakes

Frequent compliance errors include:

• Incorrect device classification.
• Treating brand ownership as manufacturing authorisation.
• Selecting an unsuitable licensing route.
• Using vague OEM agreements.
• Submitting incomplete technical documentation.
• Maintaining a paperwork-only QMS.
• Inadequate process validation.
• Using labels inconsistent with regulatory responsibilities.
• Manufacturing outside the approved scope.
• Ignoring regulatory change control.
• Assuming outsourcing eliminates regulatory responsibility.

These errors can cause application deficiencies and post-approval compliance problems. More seriously, manufacturing outside an authorised scope can expose both the manufacturing operation and affected products to regulatory action.

Risks of Manufacturing Without Proper Approval

Manufacturing regulated medical devices without required authorisation can lead to enforcement under the applicable legal framework.

Depending on the facts and statutory powers involved, regulatory consequences can include notices, restrictions on manufacturing or distribution, seizure where legally authorised, suspension or cancellation of licences, recalls, or other compliance action.

Unsafe or non-compliant devices can also create product-liability, contractual, reputational, and patient-safety consequences.

Accordingly, OEM parties should establish the lawful manufacturing route before commercial production begins.

Practical Compliance Checklist for OEM Manufacturers

OEM manufacturers operating in West Bengal should:

• Confirm each device’s classification.
• Define the legal manufacturing model.
• Identify the appropriate applicant.
• Verify licensing jurisdiction.
• Maintain an effective QMS.
• Keep technical files current.
• Validate critical manufacturing processes.
• Control suppliers and outsourced operations.
• Maintain product traceability.
• Review labels before release.
• Control design and process changes.
• Monitor complaints and post-market information.
• Maintain audit readiness.
• Document OEM responsibilities.
• Obtain required regulatory clearance before adding devices.

Conclusion

OEM medical device manufacturing in West Bengal requires more than a commercial production agreement. Manufacturers should classify each device correctly, establish a legally appropriate manufacturing structure, prepare suitable premises, implement effective quality controls, compile technical evidence, and obtain the applicable regulatory approval. They must then maintain traceability, validation, labelling, complaint handling, change control, and post-market compliance throughout the product lifecycle. Clear allocation of responsibilities between brand owners and manufacturing facilities supports regulatory consistency, but statutory obligations ultimately remain governed by the applicable medical device framework.

FAQs

1. Does an OEM medical device manufacturer need a manufacturing licence?

An OEM performing regulated manufacturing activities may require appropriate manufacturing authorisation, but the exact route depends on the device, risk class, manufacturing activities, site, and legal arrangement. A component supplier does not automatically follow the finished-device pathway. Parties should classify the device and define their manufacturing responsibilities before selecting an application route.

2. Who should hold the licence in an OEM arrangement?

Licence responsibility cannot be determined from brand ownership alone. The correct applicant depends on the manufacturing model, site, device classification, regulatory route, and applicable provisions. The parties should identify who performs regulated manufacturing and how quality responsibilities operate. A private agreement cannot substitute for the licence required by law.

3. Does the licence depend on the medical device class?

Yes. India’s medical device framework uses Class A, B, C, and D risk categories, and classification materially affects the licensing pathway. It can influence the competent authority, documentation, assessment, inspection or audit mechanism, and regulatory scrutiny. Applicants should therefore establish classification before preparing their manufacturing application and technical documentation.

4. What is the difference between a manufacturing licence and a loan licence?

A manufacturing licence generally authorises manufacture at the approved facility within its licensed scope. A loan licence involves an eligible applicant using another appropriately licensed manufacturer’s facilities under the prescribed regulatory framework. Ordinary contract manufacturing does not automatically constitute a loan-licence arrangement, so applicants should verify whether their proposed structure qualifies.

5. Can a brand owner outsource all manufacturing?

A brand owner may use outsourced manufacturing where the regulatory framework and chosen arrangement permit it. However, outsourcing production does not allow either party to disregard licensing, quality, labelling, technical documentation, complaint, or post-market obligations applicable to its role. The legal manufacturing structure should therefore be settled before commercial supply begins.

6. Is a quality management system mandatory?

Medical device manufacturing requires quality-system controls appropriate to the applicable regulatory framework and devices manufactured. The system should operate practically across documentation, suppliers, production, validation, calibration, training, non-conforming products, CAPA, complaints, traceability, and changes. Written procedures alone are insufficient when actual manufacturing practices do not follow the established controls.

7. Are OEM agreements required for regulatory compliance?

OEM agreements provide important evidence of allocated manufacturing, quality, testing, release, complaint, recall, change-control, and documentation responsibilities where multiple parties participate. However, contractual provisions cannot alter duties imposed by applicable law. Agreements should therefore reflect the lawful regulatory structure and integrate with the parties’ operational quality systems and procedures.

8. Can multiple devices be manufactured under one licensed facility?

A manufacturing facility may be authorised for multiple devices where the applicable licensing framework permits them, and each device falls within the approved scope. Manufacturers should not assume that facility approval automatically covers newly introduced products. Additional devices may require prescribed applications, technical documentation, fees, assessment, or regulatory approval before manufacture.

9. What happens if the manufacturing site changes?

Relocating manufacturing can materially affect an existing regulatory approval because the authorised site, premises, equipment, processes, quality controls, and assessment history may change. The licence holder should determine the applicable approval, amendment, inspection, or other regulatory procedure before relocation. Production should not simply transfer to a new site without regulatory assessment.

10. Can production begin while the licence application remains pending?

Submitting an application does not itself authorise commercial manufacture of a regulated medical device. The applicant should obtain the manufacturing permission required for the relevant device and arrangement before commencing activities that legally require approval. Development, testing, or evaluation activities may follow separate regulatory provisions depending on their nature and purpose.