If you are an importer and you want to Import medical devices into India, then both Form MD-26 and MD-27 are important forms that you must be aware of, for the grant of import license for medical devices under Medical Device Rules, 2017, allowing your medical device to legally brought in Indian market.

Welcome to our comprehensive guide on what are Form MD-26 and MD-27 as per CDSCO, the importance of these forms, and how they streamline the process of importing medical devices in India, ensuring your medical device meets regulatory standards. Central Licensing Authority is responsible for granting import licenses for all classes of medical devices in India.

What Is Form MD-26 and MD-27?

Form MD-26

Form MD-27

Form MD-26 is a legal application form required to be submitted to obtain the import license for medical devices under the Medical Device Rules, 2017. This form is filled and submitted by the importer seeking to bring medical devices from other countries into India. It includes information related to product specifications, manufacturer, free sales certificate, and compliance with the regulatory authority. The Drug Controller General of India appointed by the central government reviews the submitted application Form MD-26 and if the medical device meets the regulatory standard, an import license is granted under Form MD-27.

Once an importer submits Form MD-26 and the application is reviewed successfully, CDSCO grants an import license under Form MD-27. This import license ensures that the medical device has met all the regulatory requirements under Medical Device Rules, 2017. Medical devices to be imported into India require clearance from regulatory authorities, safeguarding public health by ensuring the quality and safety of medical devices.

Who Can Apply For MD-26 And MD-27?

Importer and business owner who wants to import medical devices in India can apply for Form MD-26 and MD-27.

• Manufacturers having manufacturing licenses under the Drug and Cosmetic Act, of 1940, can apply for import licenses of medical devices in India.
• Any person who wants to import and bring medical devices to the Indian market for different purposes can apply for Form MD-26 and Form MD-27.

What Are The Benefits Of Form MD-26 And MD-27?

When you apply for the license registration of Form MD-26 and Form MD-27 then you will get lots of benefits as a manufacturer and importer of India. It is necessary to obtain a medical device registration license before regulatory in India.

• Ensure Patient Safety – Regulatory compliance confirms that medical devices are of safe and quality standards for patient use.
• Improve Brand Identity – Commitment to safe and quality standards enhances brand identity, making it a trustworthy and reputable brand in the marketplace.
• Competitive Edge – Organizations that consistently comply with regulations and maintain high-quality standards gain a competitive advantage by being reliable and trustworthy towards customers.
• Legal Compliance – Ensuring that medical device meets all the regulatory requirements is essential to avoid any kind of penalties or any other legal challenges.
• Enhances Consumer Trust – Regulatory compliance and focus on safety and quality build consumer trust, which is vital for the long-term success and loyalty of customers.
• Ensuring Legal Operation – Import licenses ensure that the products meet the regulatory standard set by the regulatory authority, helping your business operate smoothly without facing any legal penalties.
• Promote Consumer Safety – The import license confirms that the product has gone through safety testing, protecting consumers from harmful effects.
• Enable Market Assess – Import licensed medical devices are only allowed to be imported legally into the Indian market. Obtaining an import license for medical devices is compulsory for introducing your product to consumers in India.

What Are The Documents Required For Obtaining Import License Under Form MD-27? 

To obtain an import license for medical devices in India, the following are the key documents that are typically required:

• Cover Letter
• Application Form (MD-26)
• Power of Attorney
• Memorandum of Association
• Manufacturing License
• Free Sales Certificate
• ISO 13485:2016 (QMS) Certificate
• Product Details
• Clinical Evaluation Report
• Fees Receipt

What Is The Validity Of Import License Issued Under Form MD-27?

Import license grant under Form MD-27 has a validity of five years from the date of issue. However, it remains valid if the applicant pays the license renewal fees every five years. In some cases, if the product is found non-compliant, the Central Licensing Authority can cancel or suspend the license.

How We ELT Corporate Can Assist You With Form MD-26 and MD-27 License?

We, ELT corporate with deep industry knowledge and expertise can help you by granting of import license under Form MD-27 for the import of medical devices in India. Let’s collaborate for a smooth and seamless process of obtaining an import license and to drive your success and meet regulatory compliance. Our offering includes:

• MD-26 Submission
• ISO 13485: QMS Certificate
• Audit Preparation
• CDSCO, SUGAM Portal Queries Response

FAQs