Medical Device Manufacturing License

In recent years, the Indian healthcare market has changed dynamically which could be accredited to increasing consciousness regarding healthcare & well-being, an increase in the disposable income in the middle-class segment, economic development, and improved healthcare facilities. Such expansion could be further driven through higher healthcare expenditures inclined by shifting demographics and a move from chronic illnesses to lifestyle-related diseases. But with increasing cases of life-endangering diseases, there is a critical need for standardized medical devices that could help more people to test, analyze and prevent such potential dangers.

For those unknown, medical devices involve a variety of types with each one focused on prevention, assistance, diagnosis, and treatment, with India being one of the leading manufacturers of medical devices in the world. Therefore, to offer quality & effective medical devices to be offered to the general public, the approval & oversight of medical devices are conducted by the State Licensing Authority (SLA) & Central Licensing Authority (CLA) under the Central Drugs Standards Control Organization (CDSCO) in pursuance of the Drugs & Cosmetics Act 1940 & Rules 1945.

Medical Devices include any instrument, apparatus, appliance, implant, material or another article, either used solely or in combination including any software or accessory designed by the manufacturer to be employed particularly for human beings or animals that don't attain the key proposed action in or on human body or animals through any pharmacologic, immunological, metabolic means but assist in its envisioned function:

• Diagnosis, monitoring, treatment, mitigation or assistance for any injury or disability.

• Diagnosis, prevention, monitoring, treatment or mitigation of any disease, or disorder.

• Examination, replacement or variation, or support of the composition or a physiological process

• Allows sustaining or support of life, Enables disinfection of medical devices, Regulation of conception

Some of the medical devices that need registration in India include spinal needles, cochlear implants, annuloplasty rings, tracheostomy tubes, dental implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, etc.

The manufacturing license for medical devices from the Indian CDSCO falls within the scope of the Central Licensing Approving Authority (CLAA) the body responsible for ensuring medical compliance under the stipulation that the licensee complies with all the requisites outlined in the Medical Devices Rules. The manufacturing of medical devices that have been officially notified falls under the purview of the CLAA scheme.

Acquiring a CDSCO manufacturing license requires meeting the prerequisite of an ISO 13485 certificate and adherence to the guidelines of the notified body. While voluntary registration shall be necessary for non-notified Class C and Class D medical devices, and from 1.10.2023, such non-notified shall be subject to compulsory licensing.

While manufacturing licenses for Class A and Class B medical devices will be authorized by the central authority with involvement from the state authority, licenses for the production of Class C and Class D devices will be directly conferred by the central authority.

Depending on the intended purpose of the device and the degree of danger they pose to the patients and the users, the Central Drugs Standard Control Organization (CDSCO) divides medical device into four categories:

• Class A: It comprises medical devices with low risk.

• Class B: It encompasses medical instruments with a moderate.

• Class C: It pertains to medical devices with a sensitive level of risk.

• Class D: It includes medical instruments with the highest level of risk.

1. Meets the Significant Requirements of the Indian Market: To address the substantial need for accessible healthcare in India, the Indian authorities are progressively depending on international manufacturers to fulfil the considerable requirement. As a result, the implementation of the medical device registration scheme becomes valuable for ensuring control and uniformity in the quality of these products.

2. Registration Monitoring and Oversight: Following registration, the Drugs and Cosmetics Act mandates manufacturers and distributors to give precedence to adhering to the provisions of the Act. This involves conducting on-site evaluations of medical devices. Manufacturers have the opportunity to aid the audit team in identifying possible concerns, thereby averting penalties for violations through product registration. This process guarantees adherence to regulations and the safety of patients.

3. Legal Protection through Compliance: Relentless pressure to maintain medical device compliance has made manufacturers worry about preparing and distributing products according to prescribed guidelines, but with medical device registration, it becomes easier.

4. Opportunities for Higher Growth & Sales: The Indian government addresses escalating demand for medical devices by allowing overseas manufacturers to enter the Indian market, ensuring compliance with CDSCO guidelines, and maintaining a high profit margin.

5. Improve Brand Identity and Market Value: The Indian market has seen a shift in manufacturers' obligations to register their products, allowing them to explore the market dynamically. However, the steep penalties make it sense not to infringe on guidelines for profit.

• Details of the Product such as Brand or Proprietary name and device category. 
• Copy of the Site Master File and Device Master File as per applicable formats. 
• Addresses of the manufacturing units and registered offices of the Manufacturer.
• Addresses of the manufacturing units and registered offices of the Manufacturer.
• Manufacturing process flowchart of devices to be manufactured on the premises.
• A detailed explanation of the manufacturing process of the devices to be manufactured.
• Copies of the ISO 13885 certificate obtained by the firm for its manufacturing premises.
• Details of the applicant entity including Names, and Addresses of the company's Directors
• Qualification and experience of technical staff under whose supervision the devices will be manufactured.
•  Method of use and intended use, Specification of the materials used, Variations in style, size, or shape of the device, if applicable, Recommended storage conditions, Brief description of the device.
• List of accessories & other devices or equipment to be used in combination with the device including Packaging description comprising pack sizes and labelling details in accordance with the Drugs & Cosmetics Act 1940 & Rules 1945.

               
Step 1: Verification of Product: The initial step in the process of importing a medical device involves confirming whether it requires registration as per the Medical Device Rules of 2017 and categorizing it as regulated or unregulated.

Step 2: Portal Registration: Next, access the CDSCO SUGAM online platform and commence the registration process to obtain login credentials. Provide your email address and other details, including a registration certificate, incorporation certificate, import-export certificate, and identification proof of an authorized individual.

Step 3: Online Application: After completing the registration successfully, access the portal and proceed to the "Online Application" category. In this section, select "Medical Devices," and proceed to indicate the specific kind of license you wish to apply for, like a manufacturing license.

Step 4: Application Submission: Complete and submit your application forms MD-3 & MD-7, accompanied by the required documents and applicable fees.

Step 5: Verification and Application Assessment: After receiving your application, CDSCO will conduct a comprehensive verification process. Following this, an inspection of your manufacturing facility will be conducted to ensure alignment with CDSCO regulations.

Step 6: Granting of Registration: Once your manufacturing facility satisfies CDSCO's criteria, a manufacturing license will be issued to you by CDSCO.

Upon being granted a license, the license holder is obligated to adhere to the following conditions:

• The licensee must keep records of manufacturing and sales, which should be made available upon request by the Medical Officer.
• The license must be presented upon request by the Medical Device Officer or any higher-ranking officials from the Central Licensing Authority or State Licensing Authority.
• If there is an occurrence of a suspected unexpected serious adverse event, the licensee must promptly notify either the State Licensing Authority or the Central Licensing Authority, along with an account of the actions taken, within 15 days.
• Any substantial modifications sought by the licensee necessitate prior approval, as outlined in the Sixth Schedule. Following approval, the licensee is obliged to furnish comprehensive information to the State Licensing Authority or Central Licensing Authority within 45 days.
• In accordance with sub-rule (3) of rule 83, the holder of the license is obligated to conduct tests in the laboratory before product release. The documentation of all conducted tests must be provided to the Central Licensing Authority or State Licensing Authority.
• If the manufacturer of medical devices standstills production for a duration exceeding 30 days, they are required to inform the relevant authority, either the Central Licensing Authority or the State Licensing Authority, about this circumstance.

Obtaining the Medical device registration could be a bit challenging due to the complex process of the documents required and the processes involved. However, with the right amount of guidance and consultation, you could easily acquire Medical Device registration within the prescribed time. At Agile Regulatory we are committed to helping budding entrepreneurs by enabling them to acquire business licenses smoothly and carry on their business.