;   Medical Translation Insight: Indian device regulations continue to evolve - ForeignExchange Translations

Indian device regulations continue to evolve - medical translationMedical device regulations continue to change in India. The Central Drugs Standard Control Organization (CDSCO) oversees India's Drug and Cosmetics Act (DCA). Under the DCA, more than a dozen categories of medical devices are listed as drugs. There are an additional number of medical devices that are listed in the DCA as "notified medical devices". These are currently regulated under the DCA and require registration.

In recent years, there has been significant discussion - and some forward movement - on how to begin regulations on the rest of the medical devices in India. In another step forward, the CDSCO released draft version of the medical device guidance documents last August. The documents can be obtained from the CDSCO website [PDF links]:

  1. Guidance Document on Common Submission Format for Registration of Medical Devices in India
  2. Requirements for Conducting Clinical Trial(s) of Medical Devices in India
The guidance sets out the expectations of the Indian authorities for device technical files, manufacturing information, and certifications that must be submitted in support of licensing application. Brandwood Biomedical points out that the content is based on the templates from the Asian Harmonization Working Party and the Global Harmonization Task Force, reflecting a trend for emerging jurisdictions to look specifically at the overseas post-market track record of new products.

The folks at Pacific Bridge Medical summarize the two guidance documents as follows:
In the "Guidance Document on Common Submission Format for Registration of Medical Devices in India," there are general instructions on how to apply for medical device registration. The guidance lists the 15 commonly required components, including: a "covering letter" (essentially a signed summary of the application's purpose and contents), an authorization letter that serves as proof of a local agent, and Form 40 (a standard form that includes information on the device, manufacturing site, fees for registration, and more), Plant Master File, etc. Most of the Indian government issued documents are included as annexes in the guidance.

"Requirements for Conducting Clinical Trial(s) of Medical Devices in India" similarly provides basic instructions on how to apply for clinical trials for medical devices. Most companies will have to include 17 parts in the application. Key forms are included in this guidance. For example, significant technical data will be required for submission, such as design analysis data, biocompatibility data, animal study data (if applicable), and more.
From a translation perspective, the guidance documents have only a limited impact. Both documents stipulate that information be provided "in English only". Unless comments and opinions received by CDSCO indicated a strong need for local-language labeling, medical device manufacturers are likely to be able to use their existing English language labeling.

For more on India, take a look at the following:
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