Pakistan Therapeutic Goods Framework: Devices and Medicated Cosmetics

1. Key takeaways

Pakistan’s institutional design places drugs, biologics, vaccines and blood products, alternative medicine products, OTC and health products, medical devices, and medicated cosmetics uniformly under the “therapeutic goods” framework, regulated by DRAP as a single authority, with medical devices and medicated cosmetics assigned together to the Medical Devices and Medicated Cosmetics Division (MD&MC Division / MDMC). The direct consequence of this arrangement is: devices are subject to an administrative system designed on the prototype of drug regulation. That single sentence carries more explanatory power for Pakistan than any amount of procedural detail: it tells a foreign manufacturer in advance that entity-level licensing, import-side controls and pharmacovigilance duties will shape the project, and that the device file will travel through channels built for drug files first and adapted for devices second.

• One authority, one framework: devices live inside the therapeutic goods system.
• The device division also owns medicated cosmetics, so the two share rule families.
• Import procedures mirror the drug import chain, not a device-native one.
• Vigilance for devices runs through the therapeutic goods vigilance rules.
• The founding statute, the DRAP Act, 2012, supplies every power that the device rules exercise.

2. Legal basis

The table below maps the framework to its sources, from the founding statute down to the vigilance rules that carry devices inside their scope. The last row is marked as pending verification, because the licence categories and the split of distribution supervision involve administrative practice that continues to settle.

3. Expert insights

Insight 1: Placing devices inside “therapeutic goods” explains every step in the Pakistani process that looks “strange”. Establishment licences, import permits, arrival notices and clearance endorsements — none of these are native concepts of device regulation; they were transplanted from the drug import system. Once this is understood, the next document required at each step becomes predictable.A company that assumes device-native logic will keep being surprised: it will ask why a product certificate alone does not clear customs, why an entity-level licence precedes any product filing, and why import documentation tracks consignment batches the way drug consignments do. All of these questions answer themselves once the drug-protoype framing is adopted, and project plans built on that framing allocate the right documents to the right stages from the start. The framing also helps in conversations with local partners, because Pakistani import professionals work in exactly these drug-derived terms, and using the same vocabulary shortens every discussion.

Insight 2: The Indian “devices as drugs” model is isomorphic but follows a different path. India, under s.3(b)(iv) of the Drugs and Cosmetics Act, 1940, “notifies” devices as drugs while maintaining separate MDR 2017 rules; Pakistan instead established a unified authority through the DRAP Act, 2012, and then made dedicated MDR 2017 rules. The latter is one step further in legislative technique, but the institutional base colour is the same. For companies operating in both markets, the shared logic helps: expectations about entity licensing, import control and pharmacovigilance-style duties transfer, even though the instruments, authorities and procedural details differ. The difference in legislative technique also has a practical edge: because Pakistan built its authority first and then made device rules under it, the device rules sit inside a settled institutional machinery, whereas regulatory announcements that look novel in other markets usually have an established administrative owner in Pakistan from day one.

Insight 3: Medical devices and medicated cosmetics sharing one division means labelling and advertising rules are shared. The labelling requirements and advertising restrictions for devices come from the same body of provisions as those for medicated cosmetics (Chapter VI of MDR 2017 and related provisions), and the review positions can be read across from one to the other. A labelling fix made for a device product can usually be anticipated for a medicated cosmetic product, and vice versa, which saves review cycles for portfolios that span both categories. It also means a single internal team can own both categories’ compliance language, keeping terminology consistent across labels, inserts and advertising copy.

4. Practical recommendations

• In GRZAN training for clients on Pakistan, the “therapeutic goods” concept is taught first, and the device process is taught second.
• We have found that once clients understand the pharmaceutical base of the system, the cost of understanding establishment licences, arrival notices and clearance endorsements drops sharply.
• Client preparation becomes more proactive, because the drug-import analogy lets them anticipate document needs before being asked.
• Internal checklists are organised by the therapeutic goods chain rather than by device-native stages, so the sequence matches how DRAP actually processes files.
• Vigilance obligations are briefed to clients as therapeutic goods duties under the Pharmacovigilance Rules, 2022, not as device-only obligations.
• Where supervision at the distribution stage is at issue, the provincial health department role is flagged as pending verification before any advice is given.

5. Verification checklist

• □ Understood that devices sit inside the “therapeutic goods” framework
• □ Anticipated the document needs of later stages using the drug import system
• □ Confirmed that labelling and advertising rules share the same source as medicated cosmetics
• □ Distinguished the Pakistani path from the Indian “devices as drugs” path
• □ Included the concept explanation in internal training materials

Regulatory information verified as of 28 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Pakistan. Our team prepares dossiers to DRAP expectations, manages eCTD-format submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com