FMCS Registration & ISI Mark for Medical Devices - Process & Fee

Introduction

Medical Devices include equipment that are required in the Health Sector Industry. The equipment can be as menial as a Band-aid and as crucial as a Pacemaker. 

Medical devices must adhere to the specifications set forth by BIS and established under Section 3 of the BIS Act of 1985.  

Any standard for medical devices  that is not covered under BIS ACT OF 1985 shall comply with ISO (International Standard Organization) standards. In case medical equipment standards are not specified in any rule it shall conform to validated manufacturer’s standards 

Foreign manufacturers must have FMCS accreditation in order to trade medical devices into India. While Indian manufacturers are permitted to create and market medical products with the ISI Mark.

Few health-related items are traded under voluntary certification, although some essential medical equipment must be FMCS Certified in order to be sold. 

Note: Any medical device standard that does not comply with the BIS Standard shall comply with ISO (International Standard Organization) . If any standard does not comply to BIS or ISO Standards, they shall conform to the validated manufacturer’s standards”

 

Table of Contents:

1. Why are Certifications important?

2. FMCS Registration

3. Prerequisite for FMCS Registration

4. Process of FMCS Registration

5. ISI Mark

6. Process of ISI Mark

7. Documents of ISI Mark

8. Conclusion

9. Frequently Asked Questions

 

Why are BIS Certifications is important?

Medical Devices are used for the respective Patients. Its objective is to provide aid to the public suffering from a certain illness.India is considered as one of the largest healthcare  sectors . 

Safety and Reliability is the foremost responsibility of the manufacturers. FMCS registrations ensure that all the equipment are in accordance with BIS Standards, thus securing public health.As mentioned earlier, there are several medical equipment that have voluntary certifications which poses a threat to a patient’s life . In this case , it is even more essential to obtain any of the eligible BIS Certification.

FMCS Registrations also allows manufacturers to expand their business. Such certifications work as a proof of quality assurance as well as risk-free , which leads to reliability and confidence of customers in the organization. Along with that , it helps the manufacturers to distinguish itself from the competition.  Consequently, a positive reputation of the particular organization is built which results in the increase in sales.

 

Requirement of FMCS Registration For Medical devices

FMCS is an acronym for Foreign Manufacturers Certification Scheme. It states that all Foreign or International Manufacturers must apply for BIS registration to import the medical equipment within the country. 

FMCS Registration ensures that the manufacturers who deal with Pharmaceuticals , drugs , thermometers,pregnancy kits or any implantable device produce and import High Quality Products, which are highly reliable , efficient and Safe for the use of patients. 

FMCS registration is a testament for the customers to use the medical device , in other words it benefits manufacturers in gaining the confidence of customers to make use of medical devices. 

 

Prerequisite of FMCS Registration:

• Factory Registration proof: Registration documents of the factory premise should be present. 

• Flow Chart of manufacturing Process: A copy explaining the manufacturing process of medical devices should be available. 

• Laboratory Testing Report: A laboratory report of the sample product stating the organization’s compliance with BIS Standards is required. 

• List of Testing Facilities at the factory premise : A detailed list of the various testing equipment/ machinery that are present at the manufacturing unit should be available. 

• List of manufacturing equipment/machinery: A detailed list of the various machinery that is used to manufacture medical devices is required.

• List of quality control parameters at factory: A detailed list of all the quality control protocols that are followed by the organization is listed.

 

Process of FMCS Registration: 

• First and foremost it is essential to fill out the application form to register the manufacturing company. Fill all the details that are required in the application form.

• After filling the form , the manufacturer has to pay the required fee to register themself . After the payment , a factory inspection is conducted under which quality control, machinery etc is examined. 

•  The FMCS Authority visits the premises and takes a sample of the product to examine the quality and efficiency of the drug and sends the sample to the laboratory for further processing.

• The FMCS Registration process progresses further according to the Laboratory Results. If the Laboratory result is positive i.e. if the manufacturing company’s standards are in compliance with the BIS FMCS Standards , the registration process is taken forward.

• Moving Forward, the manufacturer has to pay for the FMCS License fee as well as advance minimum marking fee. 

• Manufacturer has to sign an indemnity bond.

• Lastly, after all the successful payments , the FMCS License is  granted to the eligible manufacturers.

 

ISI MARK

ISI refers to the Indian Standard Institution .Medical Device Manufacturers can use ISI Mark if their products are conforming to BIS Standards i.e. the products consist of top quality , highly efficient, and take care of the well-being of humans and animals.

Manufacturers that are looking to produce and sell medical devices within India have to obtain an ISI Certificate.  The ISI mark is a proof that  makes the customers trust the manufacturer and utilize the medical device to resolve their medical issue. 

 

Procedure For ISI MARK Registration

• The first step for a manufacturer of medical devices is to fill an application form of registering themself to obtain ISI Mark .

•  Subsequently, a Factory Inspection is conducted to assess the factory premise and the equipment used for manufacturing.

• Product samples are tested to understand the efficacy of the product . 

• The test report of laboratory testing is thoroughly examined to finally take a decision to progress the registration further.

• If the organization conforms to the standards of BIS Standards i.e. quality assurance , well being of public etc , They are likely to be granted ISI Certification. 

 

Documents Required For BIS Registration For Medical Devices

• Registered Address of manufacturing unit: Documents of the whereabouts of  factory premises  are required.

• Laboratory Reports :  A copy of laboratory test reports of product samples are required to further progress the process.

• List of machinery used at the premise: A detailed list of equipment that are used to manufacture medical devices are required.

• Flow Chart of manufacturing process:  A copy explaining the manufacturing process of medical devices should be available. 

• Trademark proof: A trademark proof is needed.

 

Registration Fee for FMCS Certification

Applicant Fee (Non Refundable)	1000
Testing Charges	As Applicable
Annual License Fee	1000
Renewal Application Fee (Non Refundable)	1000
Late Fee for renewal	5000
Marking Fee	As Applicable
Issue of Duplicate License	1000

Note: The Fee for FMCS Registration can differ depending upon the  category of product.

 To be noted: 

Apart from FMCS Registration and ISI Mark , Medical Devices Industry can also register for CDSCO Certification. CDSCO stands for Central Drugs Standard Control Organization. CDSCO Certificate ensures quality assurance for the medical devices and the Drugs that respective manufacturers are producing, selling and importing. 

 

Conclusion:

Manufacturers who deal with trading of medical devices , Pharmaceuticals etc are required to register for FMCS Registration and ISI Mark.  Over the years, the Indian HealthCare Sector has rapidly grown into one of the largest sectors .

FMCS Registration ensures that medical devices are of efficient as well as top quality . It is important to consider the safety of the general public while trading healthcare equipment .