Skip to main content

Health Ministry Notifies New Qualification Norms for Inspectors, Government Analysts Under Medical Devices Rules


New Delhi: The Ministry of Health and Family Welfare has issued a notification to further amend the Medical Devices Rules, 2017, introducing specific qualification requirements for Inspectors and Government Analysts involved in the regulation of medical devices.

The notification, published in the Gazette of India, under G.S.R. 165(E), states that the amendments have been made in exercise of the powers conferred under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board.

The ministry noted that a draft of these amendment rules was earlier published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide G.S.R. 748(E) dated October 10, 2025, inviting objections and suggestions from stakeholders within a period of thirty days from the date on which copies of the Official Gazette were made available to the public.

Copies of the Gazette containing the draft notification were made available on October 10, 2025. The Central Government confirmed that objections and suggestions received from the public were duly considered before finalizing the amendments. 




Now, therefore, in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics

Act, 1940 (23 of 1940), the Central Government, after consultation with Drugs Technical Advisory Board, hereby

makes the following rules further to amend the Medical Devices Rules, 2017, namely: ⸻

1. (1) These rules may be called the Medical Devices (Amendment) Rules, 2026.

(2) They shall come into force on the date of their publication in the Official Gazette.

2. In the Medical Devices Rules 2017, after Rule 18, the following rule shall be inserted, namely: ⸻

“18A. Qualifications of Inspector ⸻ A person who is appointed as an Inspector under the Act for the purposes of

the implementation of the Medical Devices Rules, 2017 shall be a person who has a ⸻

(i). Bachelor’s degree in engineering or equivalent in Bio medical or Chemical or Mechanical or Electrical or

Electronics or Instrumentation or Bio-technology or Polymer or Computer Science or Medical Electronics

Engineering from a recognised university or institute; or

(ii). Bachelor's degree in Pharmacy or Pharmaceutical Science or Microbiology or Bio- Chemistry or Chemistry

or Life Sciences from a recognised university or institute.

18B. Qualifications of Government Analyst. ⸻ A person who is appointed as a Government analyst under the Act

shall be a person who has a ⸻

(a) Bachelor’s of engineering or equivalent in Bio medical or Chemical or Mechanical or Electrical or

Electronics or Instrumentation or Bio-technology or Polymer or Computer Science or Medical Electronics

Engineering from a recognised university or institute; and who possesses not less than five years' post-

graduate experience in the testing of medical devices or in-vitro diagnostics devices in a laboratory under

the control of ⸻

(i) a Government Analyst appointed under the said Act, or

(ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority

(or has completed two years' training on testing of medical devices or in-vitro diagnostics devices);


TO VIEW OFFICIAL NOTICE CLICK HERE


Comments

Post a Comment

Popular posts from this blog

Curated Compendium of Drug Discovery

  Drug discovery is a multidisciplinary process that integrates biology, chemistry, pharmacology , and cutting-edge technologies to identify and develop new therapeutic agents. From target identification to lead optimization and clinical evaluation, each stage requires precision, innovation, and collaboration. A curated list of drug discovery resources provides researchers, students, and professionals with a structured pathway to explore advancements, tools, and strategies that shape modern therapeutics. This compilation serves as a gateway to understanding the evolution of drug discovery, recent breakthroughs, and future directions, fostering knowledge-sharing and accelerating translational research. Databases and Chemical Libraries General Compound Libraries DrugBank  - Comprehensive data on approved and investigational drugs. ZINC  - Free compounds for screening. ChemSpider  - Chemical structures and data. DrugSpaceX  - Chemical and biological spaces. Mcule ...
Post a Comment
Read more

Understanding NMR Spectroscopy and Chemical Shift Ranges for Functional Groups

  Nuclear Magnetic Resonance ( NMR ) spectroscopy is one of the most powerful analytical tools in pharmaceutical chemistry. It helps chemists determine the structure, purity, and chemical environment of molecules by analyzing the behavior of nuclei (commonly ¹H or ¹³C ) when exposed to a strong magnetic field. In proton NMR ( ¹H-NMR ), the chemical shift (δ, in ppm) provides information about the type of hydrogen atoms present in a compound and their surrounding electronic environment. Depending on nearby atoms and functional groups, signals appear in specific regions of the spectrum — often referred to as upfield (shielded, lower δ values) or downfield (deshielded, higher δ values). The image above summarizes the characteristic δ ranges for different functional groups in ¹H-NMR. Let us break it down systematically: 1. Downfield Region (δ 12 – 6 ppm) Hydrogens in this region are strongly deshielded due to electronegative atoms or π-bond systems. Carboxylic Acids (–COOH) : δ 1...
Post a Comment
Read more

Pushing the boundaries of computational drug discovery at Isomorphic Labs

  The Isomorphic Labs Drug Design Engine (IsoDDE) has unlocked a new frontier in in-silico drug design, representing a significant evolution beyond AlphaFold 3. What IsoDDE delivers: 🔹 Massive accuracy leap on unconstrained structure prediction The engine more than doubles AlphaFold 3's accuracy on extremely challenging protein-ligand prediction tasks — including systems far outside the training distribution. 🔹 Best-in-class binding affinity prediction IsoDDE predicts how strongly small molecules bind to targets with accuracy that exceeds gold-standard physics-based methods, at a fraction of the computational cost and time. 🔹 Blind identification of novel binding pockets Even without existing structural data, the engine reveals previously unseen binding sites — just from an amino acid sequence — enabling drug designers to explore entirely new chemical action spaces. 🔹 Expanded support for complex biologics Beyond small molecules, the engine boosts prediction fidelity for...
Post a Comment
Read more