A Free Sale Certificate (“FSC”) is a certificate issued by the national regulatory authority of the exporting country on the basis of national legislation stating that the product is freely available in the country but without any confirmation that the product is tested for safety and effectiveness and is licensed for use in the country.
The Free Selling Certificate is also known as the "Export Certificate" or the "International Government Certificate." It offers confirmation from a foreign entity that the goods included in the certificate are freely distributed and produced in a country that intends to export a specific drug.
In India, the State licensing authority is responsible for issuing the Free Selling Certificate for export purposes.
The exports of medical devices are dealt with by Rule 91 of the Medical Devices Regulations 2017 ("Laws"). When a person wishes to export any medical device manufactured in India, he must apply for a certificate of quality, health and performance with regard to the medical device in the form of a free sale certificate or a credential, which is provided by the importing country authority. The Central Licensing Authority shall grant a certificate to the applicant if the required conditions are met. The guide has been issued under Rule 91 by the CDSCO
Free Sale Certificate is compulsory for import or export of medical devices to and from India. Free Sale Certificate has certain benefits as well:
1. Verification of the Manufacturer
Although verification that the manufacturer is an authorized business entity can be carried out in a number of ways, CFS is a definitive proof that the manufacturer contains a valid license. An authentication of the producer's license immediately validates that the company complies with the CE labeling guideline.
2. Facilitates Verification of the Product
Importing countries want to maintain a strict level of health and safety in their healthcare sector. They will therefore not permit the use by a manufacturer of medical devices, pharmaceutical products and other critical products which can not provide proof that a certain exporting medical product is authorized to be used in the country where it is based.
For this purpose, CFS is an important piece of information where an associated regulatory body vouches to the importing manufacturer that a specific certified medical device is an authorized health product in the county where it is manufactured.
3. Verification of GMP Certification
CFS also confirms that the device in question complies with the Good Manufacturing Practice (GMP) guidelines of the International Society for Pharmaceutical Engineering. Apart from the CE marking, there is another important certification which further confirms the veracity of any medical product.
As you can see how important the CFS information for a medical device can be. The fact that it makes CFS more important is that it is essentially a guarantee issued by the importing country to the exporting country as to the authenticity of the manufacturer and its product.
For manufacturers interested in moving globally with their medical devices, we can provide them with the services to apply and secure CFS from the Ministry of Exports. We also provide the necessary tests required for CE marking and other relevant certifications.
4. Mandatory for permission to import medical devices
FSC is a mandatory attachment for application to import medical devices (MD-15) in India.
1. The following documents are required for the issuance of a Free Sale Certificate – Request in the Descriptive cover letter form.
2. Copy of valid manufacturing licenses
3. List of products for which a Free Sale Certificate is needed
4. Copies of the Product
5. Permission Letters of the requested products for the issuance of Free Sale Certificate
6. Fees of Rs. 250/-+ service Tax per Free Sale Certificate containing a maximum of 10 products in one certificate and Rs. 50 + service Tax for each additional copy in the form Demand draft or pay order. The list can vary depending on the requirement of the regulatory authority from time to time.
The validity of a Free SaleCertificate is of 2 years from the date of issue.
➲ Prepare and file the application along with a cover letter and respective attachments.
➲ Submit a list of products for which the Free Sale Certificate is required
➲ Make a payment of INR 1000 (prescribed fees) in accordance with the second schedule of Rules for Certificate to export medical device. The fee is to be paid for each distinct medical device through electronic means of a challan vide the banks authorised by the Ministry of Health and Family Welfare.
➲ Once the licence is issued, share a valid copy of same with the manufacturer for Sale or for Distribution of Medical Devices along with the list of approved products issued by the competent authority (State Licensing Authority or Central licensing).
➲ The application is to be accompanied by an undertaking stating that no action has been initiated against the applicant pertaining to adverse events or market complaints and Not of Standard Quality (NSQ) report of any product in India.
We share the detailed and reasonable estimated costs, documents and prerequisites for the complete process before starting the process to ensure transparency.
Our team warrants hassle free documentation. We collect the necessary documents and share the relevant drafts to ensure a timely filing and delivery.
Upon collecting the necessary documents and information, we waste no time in preparation and filing of your application. development on your application is brought to your attention.
On successful completion of the case we share all the relevant documents electronically and physically along with an assurance to pay you back if something is wrong.
Registration for PF is compulsory for the companies / Organizations who employ 20 or more individuals. Also, a small organization that does not have the maximum Strength can register them voluntarily. The organization which grows to strength of 20 membersRead More
All the business which are operating in the market and want to get a legal existence and want avail benefits under MSME scheme can get register themselves under Micro, small and medium enterprise development act 2006 and as per government enacted act MicrRead More
In 2017 parliament if India has passed the Goods and Service Tax act (GST act) and this act came into effect from 1st July 2017. It’s an indirect tax which replaced many other prevailing indirect taxes in India. It is all in one tax which includes a vRead More
Startup means an entity, incorporated and registered in India which fulfils the following: Is any of the following Private Limited Company Public Limited Company Limited Liability Partnership Partnership Firm The annual turnover of the applicant sRead More
RNI stands for the Registrar of Newspapers of India. RNI registration is a mandatory requirement to start a business of newspapers, magazines or journals in India. In India all the publishing industry is governed under the press and books registration actRead More
In India, the real estate sector plays an important role in meeting the housing and infrastructure growth needs and demands. Although this sector has developed rapidly in recent years, it has been largely unregulated, given the absence of professionalismRead More
An autonomous body created by the law under the Ministry of Labour and Employment, Government of India is known as Employee State Insurance Corporation. This scheme is started for Indian workers. The workers get a huge variety of medical, monetary and othRead More
NSIC stands for National Small Industries Corporation. It is a Govt. of India enterprise with the aim of helping small and micro-entrepreneurs to flourish in business activities. NSIC operates through a countrywide network of offices and aims to promote aRead More
No person shall begin or carry on the export business of any spice, unless it has obtained registration under Spice board for making such export. The Spices Board is the regulatory and export promotion body for Indian spices under the Indian governmentRead More
Under Ayushman Bharat or National Health Protection Scheme, every qualifying family will receive an annual rs.5 lakh insurance premium Benefits under this scheme are not exclusive to any hospital or branch in question. The patient will benefit from anyRead More
The Legal Metrology Directorate is a separate government department of the Ministry of Consumer Affairs, Food and Public Distribution. Legal Metrology is responsible for the standards and regulations relating to measurements and weights of measuring instrRead More
A Free Sale Certificate (“FSC”) is a certificate issued by the national regulatory authority of the exporting country on the basis of national legislation stating that the product is freely available in the country but without any confirmationRead More
MSME udyog aadhar registration has been replaced by Udyam Registration with effect from 1st of July 2020 as per the notification dated 26th of May 2020. The Ministry of Micro small and medium enterprises notified certain criteria for classifyingRead More
Pursuant to the amendments in the 1975 Professional Tax Act , a person (natural / legal) registered under the MGST Act is liable to register for Professional Tax Enrollment Certificate (PT-EC) and pay Rs.2500 annually. Furthermore, if the business has anyRead More
PSARA License is a prerequisite before any person in India starts a private security company. The Private Security Agency is an entity involved in providing security guards and other related services as an alternate to the police at an establishment. TheRead More
Registration and regulation of clinical establishments are provided for in the Clinical Establishments Act. Health facilities throughout the country with a view to prescribing essential care Minimum criteria for special kinds of facilities and servicesRead More
Pursuant to the 1948 Factory Act, it is compulsory for each factory owner to register their premises with local authorities before starting a business. Factory License acts as an approval document provided by authorities to carry out manufacturingRead More
Uniquely repurpose strategic core competencies with progressive content. Assertively transition ethical imperatives and collaborative manufactured products.Write About Us
© 2022 Corpzo Ventures Private Limited.