Medical Device Sales Distribution License in Bhar

Are you dealing with medical devices manufacturing or sales licence in Bihar then must understand about sales distribution license in Bihar. It is mandatory to obtain for all the seller and distributor of medical devices. With the help of Nawcare Business Solutions you can simply apply for the medical device sales distribution license.

The Medical Device Sales Distribution License (MD 42) in Bihar is a regulatory requirements in India. It is necessary for the businesses that are involved in the sales, distribution and wholesale of medical devices. The medical device license is a part of medical devices rules, 2017. 

The medical device rules are implemented by the CDSCO (Central Drugs Standard Control Organization) under the drugs and cosmetics act, 1940. The purpose of these rules and license ensure that medical devices in the market are safe, effective, and meet quality standards.

To obtain the license you have to understand the few more aspects that help you to boost your business and regulatory of medical devices in India. So when you applied for this then must consider all these aspects to obtain MD 42 sales and distribution license in India:

Eligibility

Entity such as wholesalers, distributor, or retailer involved in the sale of medical device must obtain the sales and distribution license. This includes both Class A & B devices (Low to Moderate risk.

Required Documents

• Application Form (MD 42)
• Proof of ownership and tenancy of the premises.
• Details of the responsible person with qualifications (pharmacist or competent person).
• Authorized person identity and address proof.
• Undertaking for compliance with the provisions of the Medical Devices Rules, 2017.
• Proof of the registered office and premises layout.

The facility must have adequate storage space, including temperature-controlled areas for temperature-sensitive devices. The premises should comply with good storage practices to ensure the safety and efficacy of the products.

Qualified Personnel

A registered pharmacist or a competent person with at least one year of experience in handling medical devices must be appointed to oversee operations.

MD 42 Application Fees

The application fee of the MD 42 needs to be submitted as per the regulatory guidelines. The fees of the license may varies as per the state and the type of medical devices handled.

Compliance

License must comply with the labeling requirements, storage standards, and maintain proper records of sales, distribution, and recalls (if applicable). The CDSCO regularly inspects premises to ensure adherence to guidelines.

Validity and Renewal

The license validity is 5 years, after that it must be renewed. Renewal application should be submitted at least 3 months  before the expiry date.

PROCESS OF REGISTRATION WITH US

List Of Documents Required For Application Of MD-41

• Details of the applicant or firm including its constitution, along with identification proof, such as, Aadhar card or PAN card.
• Documentary evidence in respect of ownership or occupancy on rental of the premises.
• Educational Qualification Details of competent technical staff.
• Experience Details of competent technical staff.
• Brief description on other activities carried out by applicant, namely, storage of drugs, medical items, food products, stationeries, etc., or any other activities carried out by the applicant in the said premises.
• Self-certificate of compliance with respect to Good Distribution Compliance.
• An undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device .
• Any Other Documents like GST, Trade License, and Premise Plan etc.

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