BIS Medical Device Standards 2026: Five Standards Established

The Bureau of Indian Standards (BIS) has notified five BIS medical device standards in 2026 covering microwave therapy apparatus, photodynamic therapy and diagnostic apparatus, home light therapy apparatus, and medical endoscopes and endotherapy apparatus. The standards were developed on 3 August 2026.

The notification is dated 5 August 2026 and was published in the Gazette of India on 12 August 2026 under reference HQ-PUB013/1/2020-PUB-BIS (1584). For three revised standards, BIS has allowed the earlier editions to remain in force concurrently until 3 February 2027. The other two entries are shown as new standards with no earlier standard or withdrawal date listed.

Manufacturers, importers, testing laboratories, product designers, quality control units, and buyers involved with the equipment listed above need to determine the relevant standard and evaluate the technical documentation during the transition. The notification sets and revokes the standards but does not itself indicate that BIS certification or the Standard Mark is mandatory.

Notification at a Glance

The Regulatory Framework

BIS is India's national standards body. The present notification was issued under Rule 15(1) of the Bureau of Indian Standards Rules, 2018. Rule 15 deals with the preparation, publication, revision, and withdrawal of Indian Standards. Schedule is the part of this notification that works: it mentions the new edition, its date of adoption, the previous edition, if any, and the date of its withdrawal.

This notification should not be confused with a Quality Control Order (QCO). BIS guidance explains that product certification is generally voluntary. At the same time, the Central Government can make conformity and use of the Standard Mark compulsory through a QCO or another applicable legal instrument. No QCO, mandatory Standard Mark direction, license condition, certification scheme, enforcement provision, or penalty appears in this five-page notification.

The listed standards draw on publications of the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO). The Gazette identifies three IEC-based standards for medical electrical equipment and two ISO-based standards for endoscopes. The technical text of those standards is not reproduced in the notification, so clause-level product requirements must be checked against the complete standards themselves.

Scope and Applicability

The notification applies only to the five stated standards, not to all devices or all types of electrical medical equipment. Applicability depends on whether the product falls within the scope of any of the mentioned standards.

The document does not mention any exemptions, risk classifications, turnovers, locations, or special considerations for MSMEs. In addition, it does not state that all manufacturers, importers, or distributors are obliged to make an application immediately. These considerations depend on the complete standard and the related medical device or BIS instrument.

What Has Changed

BIS established five standards on the same date. Three are revised editions with six months during which the old and new versions remain in force together. Two are listed without a predecessor.

The notification does not provide a redline or clause-by-clause comparison. A business should not assume the changes are limited to the amended years shown in the titles. A proper gap review requires the complete old and new standards.

Detailed Standard-Wise Analysis

IS 13450 (Part 2/Sec 6): 2026 - Microwave Therapy Equipment

This is the first revision of the Indian Standard that contains specific requirements for the basic safety and essential performance of microwave therapy equipment. BIS identifies it with IEC 60601-2-6:2012, Amendment 1:2016, and Amendment 2:2022, in consolidated form, with modifications.

Indian Standards of 2018 and their revisions until 2026 will remain relevant until 3rd February 2027. For businesses using the 2018 standard, they can check for changes in the technical specifications between the two versions of the standard and identify which designs, tests, risks, and products will require modification. The notice provides no list of modified clauses and testing.

IS 13450 (Part 2/Sec 75): 2026 - Photodynamic Therapy and Diagnosis Equipment

This standard address particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment. It is identified with IEC 60601-2-75:2017 and Amendment 1:2023 in consolidated, modified form.

The schedule has marked NA for both the earlier standard as well as the withdrawn date of the same. Based on the information provided, the BIS has not identified any predecessor that runs parallel to it. However, this is not conclusive evidence of the absence of any other general/collateral/product standard which may be applicable.

IS 13450 (Part 2/Sec 83): 2026 - Home Light Therapy Equipment

This new entry covers particular requirements for the basic safety and essential performance of home light therapy equipment. It is linked to IEC 60601-2-83:2019 and Amendment 1:2022 in consolidated, modified form.

Unlike Section 75, the Gazette has no precedent for this standard and no withdrawal date. It would be best for manufacturers and importers to ensure that the product falls under the jurisdiction of Section 83 first. This is because the title alone must not determine whether equipment belongs to this category.

IS 15732 (Part 1): 2026 - General Requirements for Endoscopes

IS 15732 (Part 1): 2026 is the second revision of the general requirements standard for medical endoscopes and endotherapy devices. It adopts ISO 8600-1:2025. The earlier IS 15732 (Part 1): 2018, based on ISO 8600-1:2015, remains in force until 3 February 2027.

The heading is rather broad and could influence product specifications and technical documentation across a range of endoscopes and endotherapy devices. The Gazette does not include the new technical provisions. Companies will have to obtain the complete 2026 standard in order to make an accurate comparison.

IS 15732 (Part 4): 2026 - Maximum Width of the Insertion Portion

IS 15732 (Part 4): 2026 is the second revision of the method for determining the maximum width of the insertion portion of medical endoscopes and endotherapy devices. It adopts ISO 8600-4:2023. The earlier 2021 Indian Standard, based on ISO 8600-4:2014, is scheduled to be withdrawn on 3 February 2027.

All concerned teams, engineering, metrology, quality, and testing, should review whether the new procedure modifies any procedures, equipment, acceptance documentation, or product dimensions. Since no figures, tolerances, or procedures are provided in the notice, none should be derived from the title.

Meaning of CSV, MOD, and Revision Labels

The standard titles contain technical publication labels that help readers identify the source edition but do not replace the full Indian Standard.

CSV means consolidated version. IEC explains that a CSV merges a publication and its amendments into a single document.

MOD indicates that the Indian Standard is a modified adoption of the referenced international standard. Product teams should therefore use the Indian Standard and identify the national modifications rather than relying only on the IEC text.

The first and second revisions identify the revision status of the Indian Standard. They do not, by themselves, describe which clauses changed.

NA in the predecessor and withdrawal columns means the schedule lists no earlier standard for withdrawal for that entry.

Implementation Timeline/Norms

It is clear from The Gazette that February 3, 2027, is not mentioned as a universal certification deadline. These are just withdrawal dates of three identified standards. Any conversion requirement arising from a license, QCO, purchasing agreement, or medical device approval should be assessed according to the instrument that creates the requirement.

Old vs. New Requirements

The authenticated comparison is restricted to edition identification, international publication citation, and transfer date due to the absence of the technical content of the standards in the Gazette.

An old-versus-new comparison table cannot detail the technical differences between the two editions because access to both versions is unavailable.

Does This Notification Make BIS Certification Mandatory?

This notification does not impose any mandatory BIS certification. This notification issued by BIS is based on Rule 15(1). This rule involves both the establishment of new standards and the discontinuation of existing ones. There is nothing in this notification about the compulsory use of the standard mark. Neither is there any BIS license, conformity assessment scheme, nor any penalty.

The BIS's formal guidance on QCO distinguishes between voluntary and mandatory certification through the QCO process. Hence, businesses are required to perform the second check with regard to any QCO, license condition, procurement requirement, regulatory requirement in connection with medical devices, or other legal document that may reference these standards. However, the impact depends on the instrument itself and is not implied by this notice.

Impact on Businesses

The direct impact on business will be to determine whether a listed standard is applicable and, for revised standards, whether existing technical data remain applicable when the older edition is phased out.

Manufacturers and Product Designers

• Map each model and variant to the relevant standard instead of applying the notification to the entire product portfolio.
• Obtain the complete 2026 standard before changing product design, specifications, labels, or test plans.
• Compare old and new clauses for the three revised standards and document the effect on design inputs, risk controls, and verification evidence.
• For Sections 75 and 83, conduct a fresh scope assessment because no predecessor is listed.

Importers, Distributors and Institutional Purchasers

• Ask suppliers which edition supports the product's technical evidence and whether transition work is planned.
• Review contracts, tender specifications, and purchase requirements that cite an older standard.
• Avoid describing the product as legally required to hold BIS certification solely because the standard appears in this notification.

Laboratories and Quality Teams

• Confirm whether test methods, equipment, measurement procedures, and report templates align with the new edition.
• The two different editions need to be clearly separated during concurrent validation.
• Include the standard's number and year in the report to avoid confusion.

MSMEs and Startups

There is no specific transition period or exemption given for MSMEs and startups. Smaller business establishments will find it more challenging to meet standards, conduct gap assessments, and update technical files.

These cost effects are likely implications, not charges imposed by the Gazette. No testing fee, certification fee, or compliance cost is specified in the notification.

Benefits for Businesses

This amendment ensures companies have a well-defined history of the editions and transition period for three standards. Some possible advantages are:

• an updated Indian reference based on recent IEC or ISO publications;
• proper identification of standards belonging to new classes of products such as photodynamic therapy and light therapy equipment; and
• an opportunity to compare three obsolete editions before withdrawal.
• more consistent edition references in design, testing, procurement, and quality records;
• an opportunity to remove outdated specifications from contracts and technical files; and
• Better coordination among engineering, regulatory, quality, and purchasing teams.

These are the practical advantages of proper standards management. The announcement will not ensure any certification, regulation, market access, product safety, or commercial success.

Challenges and Cost Implications

The main problem here is that the standards are included in the Gazette, but the technical information contained in them is not. A good assessment will require comparing the standards with earlier versions.

Possible short-term cost issues might include engineering review, acquisition of standards, lab capability review, supplier coordination, document revision, and testing as necessary according to the gap assessment process. There might also be recurring costs due to the different controls required by the revised method. The quantity or rate cannot be given from this source.

Two additional items will require careful consideration. In the absence of an older standard, teams may have to develop a scope and evidence map rather than rely on a migration file. At the same time, teams must determine if any other standards still apply.

Risks and Consequences of Non-Compliance

There is no punishment prescribed for non-compliance with the notification. Therefore, it would be incorrect to say that failure to meet the deadline of 3 February 2027 will result in a penalty or recall.

However, practical risks may emerge if the company continues to reference the withdrawn standard in testing reports, tenders, contracts, and technical specifications. If other binding documents or licenses require the use of the existing Indian Standard, then the consequences of migration should be evaluated separately.

Best Practices

• Maintain a controlled standards register with the exact part, section, year, establishment date, and withdrawal date.
• Assign an owner for each affected product family and record the scope decision.
• Obtain the full standards and use a traceable clause-comparison method for revised editions.
• Separate legal requirements from voluntary technical improvement and customer-specific requirements.
• Record which external instrument, if any, makes conformity or certification mandatory.
• Update supplier questionnaires, purchase specifications, and laboratory instructions with the correct edition year.
• Retain approval for each change to design, testing, or documentation.

Common Mistakes or Risks to Avoid

• Treating the Gazette publication date as the date of establishment.
• Calling 3 February 2027 a universal certification deadline rather than a withdrawal date for three standards.
• Assuming “NA” means no other standard or regulation can apply.
• Using only the referenced IEC or ISO document without checking modifications in the Indian Standard.
• Claiming BIS certification is mandatory without locating the instrument that creates that duty.
• Describing technical changes without comparing the complete old and new standards.
• Applying one listed standard to all medical devices based only on a broad product description.

Future Outlook

The only confirmed future action in the notification is the withdrawal of three earlier standards on 3 February 2027. No future review, amendment, certification deadline, or additional phase is announced.

Companies must keep an eye on BIS and relevant sectoral regulators for manuals, implementation guidance, QCOs, license directions, and any other notices. Monitoring is a practical suggestion and not an action to be taken in the future.

What Businesses Should Do Next

How Can Corpseed Help?

Corpseed supports manufacturers, importers, and other businesses affected by the 2026 BIS medical-device standards update. The support is tailored to the product, applicable standard, and actual compliance requirements.

1. Checking Which BIS Standard Applies

Corpseed can help determine whether the new standards cover a particular medical device.

• Review the product’s purpose, design, and technical features.
• Identify the relevant BIS standard.
• Check different models and product variants.
• Avoid applying an unrelated standard to the product.

2. Mapping Products to the Correct Standards

A business may manufacture or import several devices. Each product must be assessed separately.

• Prepare a product-to-standard mapping.
• Separate covered products from products outside the notification.
• Identify the correct standard number, part, section, and year.
• Create a clear reference for regulatory and quality teams.

3. Comparing Old and New Standards

Three earlier standards will remain valid only until 3 February 2027. Corpseed can support a structured comparison when the complete editions are available.

• Compare the old and revised standards.
• Identify changes affecting the product.
• Highlight possible gaps in existing technical records.
• Prepare a practical transition plan.
• Help teams prioritize actions before the older standard is withdrawn.

4. Reviewing Technical Documents and Test Reports

Technical documents should mention the correct standard and edition.

• Review product specifications and technical files.
• Check test reports and supporting records.
• Identify outdated or incorrect standard references.
• Review whether available evidence supports the applicable standard.
• Suggest document updates where necessary.

5. Supporting Product Testing

Testing should be arranged only after confirming that it is required and identifying the correct standard.

• Help determine whether additional testing may be needed.
• Identify the relevant testing scope.
• Support coordination with a suitable laboratory.
• Review whether test reports mention the correct standard and edition.
• Help organize testing records for future reference.

6. Checking BIS Certification and QCO Applicability

The 2026 notification establishes and withdraws standards. It does not, by itself, make BIS certification compulsory.

Corpseed can help businesses:

• Check whether a separate Quality Control Order applies.
• Review whether a BIS license or Standard Mark is required.
• Examine other applicable certification or regulatory conditions.
• Separate voluntary standards from mandatory requirements.
• Avoid unnecessary certification applications or unsupported compliance claims.

7. Planning the Transition and Ongoing Compliance

Businesses using the three older standards should prepare for their withdrawal on 3 February 2027.

• Create a product-specific transition plan.
• Assign responsibilities to regulatory, quality, and technical teams.
• Update internal standards registers and compliance records.
• Review supplier and laboratory documents.
• Monitor relevant BIS and regulatory updates.
• Maintain clear records of compliance decisions and completed actions.

A medical device regulatory consultant helps connect the correct product, technical standard, and legal requirement. Corpseed can support businesses dealing with microwave therapy equipment, photodynamic therapy and diagnostic equipment, home light therapy equipment, medical endoscopes, and endotherapy devices.

Businesses may contact Corpseed for a document-specific assessment and practical support with medical-device compliance. Certification, approval, or a fixed regulatory result is not guaranteed.