New guidance notes for import and sale of medical devices

The central government has issued new notifications to regulate the manufacture, sale and distribution of medical devices in India. The notifications categorize 14 sterile medical devices as “drugs” within section 3(b) of the Drugs & Cosmetic Act, 1940. The new guidelines have been introduced to eliminate the hazards associated with the import and manufacturing of substandard medical devices.

Issuing notifications in 2005 and recently to identify medical devices as drugs is the first step towards regulating these devices in India. Despite this initiative, specific rules relating to product standards, safety, clinical trials and manufacturing practices for each device have yet to be drafted.

The Ministry of Health and Family Welfare has now approved a process to license the import and manufacture of these devices. The office of the Drug Controller General of India has uploaded the proposed requirements for the procedure on its website (www.cdsco.nic.in) for stakeholders likely to be affected. Any comments on the requirements need to be submitted by 30 September.

The legislative and regulatory update is compiled by Nishith Desai Associates, a Mumbai-based law firm. The authors can be contacted at nishith@nishithdesai.com. Readers should not act on the basis of this information without seeking professional legal advice.