Regulatory Pathway for Manufacturing Medical Devices

Actually, the COVID-19 pandemic has halted the world. Infections on a vast scale have contributed to global lockdowns. Tests are the most crucial step to get a grip on the situation at this vital juncture. There is no distinction between the situation in India. The need for rigorous testing has become paramount in the face of a rise in the number of COVID-19 cases in India. Low supply of test kits continues to be a significant problem for the government and health professionals. This is aggravated by our large population, considering the sum needed in the current scenario. This lack of availability of test kits mainly is the lack of sufficient indigenous COVID-19 test kits in India, which rely heavily on imported kits.

From the regulatory point of view, these kits fall under an 'in-vitro diagnostic' category, as given under the D&C Act of 1940, and are governed in compliance with the Medical Devices Rules of 2017 (MD Rules).

Pathway to Obtain Manufacturing License for Test Kits

If any company wishes to build a COVID-19 test kit in India, then before beginning commercial development of their kits, they will need to follow the following regulatory path:

Step 1: Test License

Process:

According to Article 31 MD Law, for clinical trials, research, measurement, evaluation, evidence, or training, the Drugs Controller General of India (DCGI) shall be authorised to manufacture even small amounts of any medical product. This license allows the developer to create samples and test the test package for the same. Such a license shall be given in MD-12 and MD-13. The following details must be added to a request for a grant of a test license:

1. A brief medical product overview, including planned uses, construction material, designs, and undertakings specifying, for the manufacture of such medical devices, the appropriate facilities, including machines, instruments, and staff;
2. A detailed list of equipment and machines installed;
3. List of the competent personnel and technical staff;
4. A copy of previously issued manufacturing licences issued under these rules;
5. Letter (if any) from any Government organisation approving R&D.

Timeline:

Issuance of such a licence in Form MD-13 by DCGI is usually done within a period of 30 (thirty) days from the date of the application. However, given the current scenario and emergent situation, a shorter approval period of less than 7 (seven) days has been indicated by the regulator.

Step 2: Evaluating the Performance of the Kits

Process:

Article 59 of the MD Rules specifies that the kits manufactured shall be submitted for testing and clinical performance assessment following the satisfactory production of the test kits. Such performance assessment is carried out in line with the global practices for complying with current test requirements laid down by ICMR. In this respect, there is also a requirement for rapid inspection. If such conditions are taken into consideration of the general public interest, they may be deferred/exempted by Rule 59(4) of the MD Rule. To allow fast monitoring of the kits, various institutions like the National Institute of Virology, Pune, NIV, have been designated for the evaluation and validation of these kits by the Indian Medical Research Council (ICMR).

TImeline

For a span of less than a week, findings of such a professional assessment will be released. If it is observed that the test kits work adequately, the same are recommended for manufacturing approval, and the developer will apply for the manufacturing license. However, if the review finds problems with the efficiency of the kits, the applicant will resupply the test kits until appropriate improvements have been made to the clinical performance assessment. The ICMR updates details on test kits that are accepted on a regular basis.

Step 3: Manufacturing / Import License

Process

After the ICMR / NIV / other properly approved testing institutes have issued a satisfactory report, the developer shall seek a license to import/manufacture certain COVID-19 kits for import/manufacture for sale or distribution in India. A variety of supporting documentation and records will be needed to accompany this application. The processing plant must also be tested by the regulatory authority until a license is issued under Rule 21(5). Then a Manufacturing License or Leasing Manufacturing License is issued in Form MD-9 or Form MD-10, as applicable, where all is in order, if applicable.

Timeline:

The time taken for the issuance of the license in the ordinary business course can be up to 105 (100 and 5) days from the date of the applicant's submission. The actual emerging condition has, however, been minimized by this time frame.

Expedited process of Approval

On 19 March 2020, the CDSCO released a public notice, which explained the expedited regulatory approval procedure for these test kits, in order to facilitate the manufacture and production of COVID-19 test kits and to speed up the long approval process. The CDSCO issued a public notice.

Process:

In compliance with the aforesaid correspondence, high priority will be granted to applications submitted to the CDSCO for performance appraisal and for imports and processing of in-vitro diagnostic sets for the sale and distribution, whereby the appropriate applicant will approach the CDSCO's Office for guidance on the expedited regulatory route. Furthermore, the note notes that, depending on the quality and type of the diagnostic device, current records on the product and proof of usable clinical performance appraisal data on those kits can be delayed, abbreviated, or waived on a case-by-case basis. Applications for performance assessment and import or manufacture applications for test kits for the sale or delivery are often required by an expedited review and accelerated approval process to process them on a high-priority basis.

Timeline:

For research, assessment, or further use in performance measurement, the applications for producing or importing the in vitro diagnostic kits in compliance with the above notice are required to be processed within seven days.

Conclusion

With COVID-19 issues in view, the Government and regulatory bodies have taken the opportunity to prioritize approvals and to reduce applications, paperwork, and testing criteria for critical products. The examination of test kits is carried out expeditiously, and records of such reviews are completed in less than 36 hours have been completed. Processes like the tedious inspection of the site are, in many cases, done within 1 (one) day, and within 24 hours of a satisfactory appraisal result, permissions are issued. This is an improvement in the evaluation and acceptance period, which will help to ensure that India responds to the demand for test kits that increased as a result of the current pandemic if they are continued and more streamlined. Where little else, those proactive moves are ample evidence that our regulatory authorities will face any obstacle and that this is a NEW normal way of dealing with it.

Question 1: What is the regulatory pathway for manufacturing medical devices in India?

Answer: The regulatory pathway for manufacturing medical devices in India involves obtaining the necessary licenses under the Medical Device Rules, 2017, registering the device with CDSCO, and ensuring compliance with quality standards. CorpZo helps businesses navigate this pathway efficiently.

Question 2: Do I need CDSCO approval for manufacturing medical devices in India?

Answer: Yes, CDSCO approval is a key part of the regulatory pathway for manufacturing medical devices in India. Any Class A to D medical device requires registration and licensing, and CorpZo assists with the entire CDSCO approval process.

Question 3: What licenses are required for medical device manufacturing in India?

Answer: The licenses required include a Manufacturing License under the Medical Device Rules, 2017, and product registration with CDSCO. This is an essential step in the regulatory pathway for manufacturing medical devices in India, supported by CorpZo’s expert services.

Question 4: How can startups ensure compliance in the regulatory pathway for medical devices?

Answer: Startups can ensure compliance by following the Medical Device Rules, maintaining proper documentation, and obtaining all necessary licenses and approvals. CorpZo guides startups through every step of the regulatory pathway for manufacturing medical devices in India.

Question 5: How long does the regulatory pathway for medical device manufacturing take in India?

Answer: The time for completing the regulatory pathway for manufacturing medical devices in India varies based on the device class. It can take several months for approvals and registrations, and CorpZo helps streamline the process to save time and ensure compliance.