The Bureau of Indian Standards is India’s national standard body, responsible for developing and implementing quality and safety standards across various domains including Medical Laboratory Instruments.

For manufacturers and importers, obtaining a BIS certificate for Medical Laboratory Instruments is considered their commitment to standard quality products for a high level of patient care. BIS certification for medical laboratory Instruments certifies that the product meets quality and safety standards and is a mark of trust, credibility, and stringent regulatory standards.

Connect with us for a seamless grant of a BIS certificate for your products. Our experts will guide you through the whole process of obtaining a BIS license for medical laboratory Instruments with compliance.

Overview of BIS Certification For Medical Laboratory Instruments

The BIS certificate serves as a testament to the quality and safety of products, affirming their adherence to stringent regulatory benchmarks. Obtaining BIS certificate for Medical Laboratory Instruments requires rigorous testing and evaluation to ensure compliance with established standards.

In the context of medical laboratory instruments, precision and accuracy are paramount for diagnostic and testing purposes. Consequently, these instruments must undergo a thorough assessment and secure BIS certification.

The BIS plays a pivotal role in product certification, quality assurance, and testing, thereby safeguarding consumers from potential hazards. By enforcing strict regulatory frameworks, the BIS certificate enhances consumer confidence and looks after trust in certified products.

What Are Medical Laboratory Instruments?

Medical laboratory Instruments are the specialized instruments used for conducting diagnostic tests and analysis in the healthcare sector. Below are some examples of medical laboratory Instruments  

• Microscope: Used in the laboratory for examination of tiny organisms in samples.
• Autoclave: Used in the laboratory as sterilization equipment.
• Incubator: Helps in bacterial growth and culture media.
• Spectrophotometer: Measures light absorption for testing blood samples.
• X-ray Machine: Provides images for diagnosis of fracture or disease.

Who Needs BIS Certificate For Medical Laboratory Instruments?

Following are the applicants who need BIS Certification for Medical Laboratory Instruments:

• The manufacturer is the primary applicant for the BIS certificate and is responsible for manufacturing medical laboratory Instruments.
• Importers who want to import and sell medical laboratory Instruments in India can apply for a BIS certificate.
• The distributor can apply for a BIS certificate, provided he must have the manufacturer’s authorization.
• An authorized representative may submit a BIS certificate application on behalf of the manufacturer, importer, or foreign entity.

Importance Of Obtaining BIS Certification For Medical Laboratory Instruments?

There are several benefits of having a BIS certificate for Medical Laboratory Instruments, hence listed below:

• Regulatory Compliance: Adhere to regulatory standards to ensure legal compliance, which is mandatory for selling medical devices in India.
• Quality Assurance: Ensures medical laboratory Instruments meet regulatory standards provided it has gone through rigorous testing and evaluation.
• Market Access: BIS-certified Instruments and products get easy and fast market access.
• Global Recognition: Enhances global recognition and unlocks new market opportunities.
• Market Expansion: BIS-certified Instruments and products can be easily exported to other countries.
• Brand Credibility: Build consumer trust with the ISI Mark, ensuring legal market assessment of the product.
• Patient Safety: Enhances patient confidence and builds trust in the brand, as the BIS certificate is an assurance of quality and reliability.
• Facilitates Innovation: Encourage manufacturer to innovate and improve their products to contribute to advancement in the healthcare sector.
• Improved Performance: Reduces chances of product recall from the market or rejection.

Documents Required For Obtaining BIS Certificate For Medical Laboratory Instruments

To apply for a BIS certificate for medical laboratory Instruments, an applicant must prepare and submit the following documents:

• Application Form
• Company Details
• Manufacturer Declaration
• Quality Management System (QMS) Documents
•  Product Specification
• Test Reports
• Manufacturing Facility Details
• Equipment Labels and Packaging

How To Obtain BIS Certification Medical Laboratory Instruments?

Following are the key steps involved in obtaining a BIS certificate for medical laboratory Instruments, that an applicant must follow:

• STEP 1 Visit BIS Website: Visit the BIS website and select the application form for medical laboratory Instruments and fill the form carefully.
• STEP 2 Document Submission: Upload and submit the required documents as per the requirements including product specifications, test report, and manufacturing site details.
• STEP 3 Fee Payment: Pay the required fees based on the type and number of Instruments.
• STEP 4BIS Inspection: BIS will review the submitted application along with the uploaded documents and may conduct an on-site inspection of your manufacturing site.
• STEP 5 Grant of Certification: Once the evaluation is successfully performed, and the equipment passes all the testing parameters, BIS will grant a certificate.

Also Read: BIS Certificate For Thoracic And Cardiovascular Surgery Instruments

What Is The Validity Of BIS Certification For Medical Laboratory Instruments?

The BIS certificate for medical laboratory Instruments is valid for one year, after which renewal is necessary. Renewal involves a reassessment of compliance with the regulatory standards and may require updated documentation and fees.

Timeline For Obtaining BIS Certificate For Medical Laboratory Instruments

The timeline for the grant of a BIS certification for medical laboratory Instruments takes around 5-6 months. As it is based on the responsiveness of the manufacturer and the schedule of manufacturing site inspection.

What Are The Indian Standards For Medical Laboratory Instruments?

Here we have listed down the Indian Standards for BIS certificate For Medical Laboratory Instruments, you can check them here:

SI. No.	IS No.	TITLE
1	IS 10269: 1982	Specification for haemocytometer counting chambers clinical and diagnostic apparatus
2	IS 10615: 1983	Needle Holder, Bozemann’s Pattern
3	IS 10867: 2018/ISO 6710: 2017	Single – Use containers for human venous blood specimen collection (First Revision)
	(1 Revision)
4	IS 10916: 1984	Specification for evacuated tubes for blood specimen – Collection (Vacutainers)
5	IS 11383: 1985	Specification for thin-walled glass capillary pipettes
6	IS 12622: 1989	Medical thermometers for hypothermia, subnormal range – Specification
7	IS 14284: 1995/ISO 7712	Laboratory glassware – Disposable pasteur pipettes – Specification
8	IS 16004: 2013/ISO 6009: 1992	Hypodermic needles for single use – Colour coding for identification
9	IS 3055: Part 1: 1994	Clinical thermometers: Part 1 solid stem type – Specification (Second Revision)
	(2 Revision)
10	IS 3055: Part 2: 2004	Clinical thermometers: Part 2 enclosed scale type – Specification (Third Revision)
	(3 Revision)
11	IS 3740: 1966	Specification for tubes, and glass, for pathological work
12	IS 3741: Part 1: 1990	Medical instruments sedimentation tubes – Specification: Part 1 westergren tube (Second Revision)
	(2 Revision)
13	IS 3741: Part 2: 1990	Medical glass instruments – Sedimentation tubes – Specification: Part 2 wintrobe tube (Second Revision)
	(2 Revision)
14	IS 3742: 1990	Medical glass instruments – Pipettes, dilution for haemocytometers specification (Second Revision)
	(2 Revision)
15	IS 4067: 1967	Specification for tube, swab (West Type), for throat
16	IS 4069: 1967	Specification for urinometer
17	IS 4087: 1980	Specification for pipette for haemoglobinometers and blood pipette for biochemical work (First Revision)
	(1 Revision)
18	IS 4364: 1967	Specification for pipettes, serological
19	IS 4381: 1967	Specification for pathological microscope
20	IS 4444: 1967	Specification for bottles, bacteriological
21	IS 4529: 1968	Specification for glass tubes for medical thermometers
22	IS 4708: 1968	Specification for urine glass, conical
23	IS 4754: 1968	Specification for staining troughs and jar
24	IS 5155: 1969	Specification for pipettes, Ostwald – Folin type
25	IS 6606: 1972	Albuminometer (Esbach’s) with Stopper, Stand and Case
26	IS 6942: 1973	Specification for flask, roux, bacteriological, with or without offset neck (1000 Ml Nominal Capacity)
27	IS 6943: 1990	Medical glass instruments – Cover glass used with hemckytometer – Specification (Fw Reviiim)
	(1 Revision)
28	IS 6944: 1973	Specification for bottle, bijou, bacteriological
29	IS 7039: 1973	Specification for tube, culture, screw cap
30	IS 7183: 1973	Specification for flask, culture, haffkine
31	IS 8501: 1977	Specification for anaerobic jar
32	IS 9430: 1980	Specification for tube, haemometer
33	IS/ISO 17593: 2007/ISO 17593:2007	Clinical laboratory testing and in vitro medical devices – Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Why Choose ELT Corporates For Obtaining BIS Certificates for Medical Laboratory Instruments?

At ELT Corporates, we understand the complete process of obtaining a BIS certificate along with the regulatory requirements. Our expert team can make the process easier for our clients through in-depth guidance and support, ensuring you understand each step of the certification process.

From initial consultation to certification issuance, we will be with you at every step of the way, ready to address any challenge that may arise during the certification process. With our support you will not only obtain a BIS certificate but also gain a competitive edge in the market, showcasing your commitment to quality and safety.